By: John Jordan, CIS Senior Compliance Associate
johnjordan@cis-partners.com
As we have all witnessed, the stock market can be a very volatile entity. We have seen numerous sectors fall in great lengths in something that has not been seen in many people’s lifetimes. One of the industries that has taken a hit is the nation’s biotechnology field. However, Biotechnology Industry Organization (BIO) and Thomson Reuters have predicted that this industry will rebound this year (3). BIO represents more than 1,200 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. The Corporate Services business of Thomson Reuters provides a suite of solutions across the Investor Relations, Corporate Communications, and Business Intelligence functions (1).
John Craighead, Managing Director of Investor Relations and Business Development at BIO, has stated that investors had predicted by mid-year a 15% increase in the market for the biotech field. That prediction has fallen quite short to the gains it has obtained (1). In doing some research, it looks like the large comeback for the industry is partly due to the strong positive clinical trial data. Other aspects such as acquisitions, mergers, and improvements in the market sentiment have also helped in the gains by the sector (1). One aspect that is making the public cautious, though, on biotech’s gains, is that investors predicted that the overall research and developmental productivity for 2009-2011 would be much the same as the years 2006-2008.
With everything taken into account, investors remain bullish about the industry. Two-thirds of the studied participants expect biotech to outperform healthcare and 70% expect biotech to outperform the rest of the market this year (2). With this information one can say that this is quite the bounce back.
Sources:
1. http://www.businesswire.com/portal/site/google/?ndmViewId=news_view&newsId=20090812005799&newsLang=en
2. http://www.fiercebiotech.com/press-releases/biotechnology-industry-expected-rebound-according-bio-thomson-reuters-investor-percep
3. http://www.fiercebiotech.com/story/biotech-industry-shows-signs-strong-comeback/2009-08-13?utm_medium=nl&utm_source=internal
Thursday, August 27, 2009
Tuesday, August 25, 2009
GP Forum: H.R. 3200
By: Craig Kubicek, CIS Compliance Associate
craigkubicek@cis-partners.com
On August 19, 2009 a Government Pricing monthly forum was held. The forum was led by CIS members Lauren Pellicciotti (Compliance Manager), and Chris Cobourn (Vice President of Regulatory Compliance). The topic of discussion was H.R. 3200 America's Affordable Health Choices Act of 2009. The bill was introduced by Representative John D. Dingell on July 14th 2009 and can be found online: http://www.gpo.gov/fdsys/pkg/BILLS-111hr3200IH/content-detail.html
H.R. 3200 is an extensive and comprehensive thousand page document that covers the riveting details of the current administration’s proposed solutions to America’s Health Care. As many of us know, the administration is at full-steam, pushing ahead to create a universal Health Care system that is mandatory for all American citizens. However, what many do not know or understand is the government pricing perspective of the H.R. 3200 bill. As the CIS Government Pricing forum was underway, its attendees spoke on the possible implications of the new Government Pricing changes and what might be affected and what to be expected.
In the hour the forum was held a variety of topics were touched. The conference spoke about:
o Definition in AMP (‘Other Payments’)
o Manufacturer Reporting Requirements (No later than 30 days – Added Clause)
o Disclosure of Price Information In Public (Clause Update)
o Pharmacy Reimbursements Through December 31, 2010
o Additional Rebate For New Formulations of Existing Drugs (‘S’ and ‘I’ drugs)
o Increase Minimum Rebate Percentage for Single Source Drugs (22.1%)
o Increase Minimum Rebate Percentage for Generic Drugs???
A lot of preparation will be needed in order to employ the government’s newly proposed health care overhaul. CIS and its dedicated members have already begun the needed steps of preparing. The Government Pricing forum is just another step in the right direction. Many issues are raised and constructively discussed to ensure that its members are up to date on key government pricing subjects. H.R. 3200 could be a big change for the methodologies in the Government Pricing community. The Government Pricing members are not asking themselves whether or not the new changes will work, but how can they better prepare themselves and make the transition easier.
Next on the list of subjects to discuss
craigkubicek@cis-partners.com
On August 19, 2009 a Government Pricing monthly forum was held. The forum was led by CIS members Lauren Pellicciotti (Compliance Manager), and Chris Cobourn (Vice President of Regulatory Compliance). The topic of discussion was H.R. 3200 America's Affordable Health Choices Act of 2009. The bill was introduced by Representative John D. Dingell on July 14th 2009 and can be found online: http://www.gpo.gov/fdsys/pkg/BILLS-111hr3200IH/content-detail.html
H.R. 3200 is an extensive and comprehensive thousand page document that covers the riveting details of the current administration’s proposed solutions to America’s Health Care. As many of us know, the administration is at full-steam, pushing ahead to create a universal Health Care system that is mandatory for all American citizens. However, what many do not know or understand is the government pricing perspective of the H.R. 3200 bill. As the CIS Government Pricing forum was underway, its attendees spoke on the possible implications of the new Government Pricing changes and what might be affected and what to be expected.
In the hour the forum was held a variety of topics were touched. The conference spoke about:
- The amount of money to be involved and how much of it would add to the deficit and how much would be considered revenue
- Pharmacy Reimbursement Limits:
o Definition in AMP (‘Other Payments’)
o Manufacturer Reporting Requirements (No later than 30 days – Added Clause)
o Disclosure of Price Information In Public (Clause Update)
o Pharmacy Reimbursements Through December 31, 2010
o Additional Rebate For New Formulations of Existing Drugs (‘S’ and ‘I’ drugs)
o Increase Minimum Rebate Percentage for Single Source Drugs (22.1%)
o Increase Minimum Rebate Percentage for Generic Drugs???
A lot of preparation will be needed in order to employ the government’s newly proposed health care overhaul. CIS and its dedicated members have already begun the needed steps of preparing. The Government Pricing forum is just another step in the right direction. Many issues are raised and constructively discussed to ensure that its members are up to date on key government pricing subjects. H.R. 3200 could be a big change for the methodologies in the Government Pricing community. The Government Pricing members are not asking themselves whether or not the new changes will work, but how can they better prepare themselves and make the transition easier.
Next on the list of subjects to discuss
- OMB Budget for FY 2010
- The reauthorization of SCHIP
- The extension of Medicaid rebates to Medicaid Managed Care
- Legal Immigrant Children’s Health Improvement Act of 2009
- 340B Program Improvement and Integrity Act of 2009
Monday, August 24, 2009
Fear of the Unknown: The Upcoming Flu Season
By: Suma Kallurkar, CIS Senior Compliance Manager
sumakallurkar@cis-partners.com
Every year many people worry about the flu season and faithfully obtain their flu shots in an effort to prevent or minimize illness. This year, however, anxiety over the flu has heightened significantly due to the H1N1 flu (swine flu). In the US, H1N1 flu-related illness (including hospitalizations and deaths) has continued to occur even in this summer season, which is normally flu-free. As children and parents prepare to go back to school, and other adults prepare for back-to-normal schedules at work, there is a great deal of nervousness about the H1N1 flu and the havoc it may create. The US Centers for Disease Control and Prevention (CDC) has clearly stated concerns that this flu season could be severe due to the H1N1 virus.
A vaccine for the H1N1 virus is currently in production and expected to be available in the fall. This vaccine will not be taken in lieu of the normal seasonal flu vaccine. Rather, folks who want protection against both strains of the flu will have to concurrently undergo both vaccinations. The H1N1 vaccination will probably require 2 doses spaced a few weeks apart, although some health officials are proposing that 3 doses may be required.
As often is the case, concerns exist over the quantity of the vaccine that will be produced and available. Due to the possibility of limited availability, the CDC has made recommendations on those populations that are at higher risk: pregnant women, those who care for children 6 months or younger, healthcare workers, people aged 6 months to 24 years, and people aged 25-64 years who possess health conditions that place them at greater risk of complications from the flu.
The H1N1 flu could significantly impact the workplace and business. Employers are being warned to prepare for longer absences of their employees due to H1N1 flu. No doubt the same applies for many children potentially being absent from school. A greater understanding for such absences is required, as this is what ultimately can prevent the spread of the virus. There is also a renewed emphasis on common sense activities, such as hand-washing, covering one’s mouth/nose when coughing/sneezing, and isolating oneself from contact with others.
I for one never worried about the flu much and never received a flu shot until I became pregnant. Now that I am a mother of a 4 month-old, my perspective on the flu has undoubtedly changed, as I am concerned for the well-being of my son. We all will have to be extra careful this flu season and be willing to do the little tasks, such as hand-washing, that can help prevent the spread of any flu virus. Hopefully, come the end of the flu season, we will have survived with minimal illness.
Sources:
http://www.cdc.gov/h1n1flu/vaccination/acip.htm
http://www.latimes.com/news/local/la-me-swine-flu20-2009aug20,0,4256379.story
http://www.bloomberg.com/apps/news?pid=20601103&sid=aoKnGT96tLng
sumakallurkar@cis-partners.com
Every year many people worry about the flu season and faithfully obtain their flu shots in an effort to prevent or minimize illness. This year, however, anxiety over the flu has heightened significantly due to the H1N1 flu (swine flu). In the US, H1N1 flu-related illness (including hospitalizations and deaths) has continued to occur even in this summer season, which is normally flu-free. As children and parents prepare to go back to school, and other adults prepare for back-to-normal schedules at work, there is a great deal of nervousness about the H1N1 flu and the havoc it may create. The US Centers for Disease Control and Prevention (CDC) has clearly stated concerns that this flu season could be severe due to the H1N1 virus.
A vaccine for the H1N1 virus is currently in production and expected to be available in the fall. This vaccine will not be taken in lieu of the normal seasonal flu vaccine. Rather, folks who want protection against both strains of the flu will have to concurrently undergo both vaccinations. The H1N1 vaccination will probably require 2 doses spaced a few weeks apart, although some health officials are proposing that 3 doses may be required.
As often is the case, concerns exist over the quantity of the vaccine that will be produced and available. Due to the possibility of limited availability, the CDC has made recommendations on those populations that are at higher risk: pregnant women, those who care for children 6 months or younger, healthcare workers, people aged 6 months to 24 years, and people aged 25-64 years who possess health conditions that place them at greater risk of complications from the flu.
The H1N1 flu could significantly impact the workplace and business. Employers are being warned to prepare for longer absences of their employees due to H1N1 flu. No doubt the same applies for many children potentially being absent from school. A greater understanding for such absences is required, as this is what ultimately can prevent the spread of the virus. There is also a renewed emphasis on common sense activities, such as hand-washing, covering one’s mouth/nose when coughing/sneezing, and isolating oneself from contact with others.
I for one never worried about the flu much and never received a flu shot until I became pregnant. Now that I am a mother of a 4 month-old, my perspective on the flu has undoubtedly changed, as I am concerned for the well-being of my son. We all will have to be extra careful this flu season and be willing to do the little tasks, such as hand-washing, that can help prevent the spread of any flu virus. Hopefully, come the end of the flu season, we will have survived with minimal illness.
Sources:
http://www.cdc.gov/h1n1flu/vaccination/acip.htm
http://www.latimes.com/news/local/la-me-swine-flu20-2009aug20,0,4256379.story
http://www.bloomberg.com/apps/news?pid=20601103&sid=aoKnGT96tLng
Thursday, August 20, 2009
EMEA and FDA Launching Clinical Trial Conduct Initiative
By: Jon Dellaquila, CIS Compliance Manager
jondellaquila@cis-partners.com
On August 3, 2009, the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMEA) announced a collaborative initiative examining the conduct of clinical trials submitted in drug marketing applications. The pilot program, set to begin on September 1, 2009 and last for 18 months, will provide an opportunity for the two organizations to work together and allow for the sharing of information regarding good clinical practice (GCP) inspections conducted by the FDA and EMEA.[1] The intentions of the initiative will provide an open dialogue between the two organizations leading to a more efficient use of resources while improving the quality of clinical trials.
Facing a global economic recession, it is not surprising that some government agencies have begun assessing ideas to harmonize similar procedures. Currently, a large number of clinical trial participants come from the United States and the European Union - increasing the emphasis on why it may be important for these two organizations to work together. Since each agency operates with limited inspection resources, only a small sample of clinical trials can be inspected.[2] The scope of this program will allow for each organization to essentially double the number of inspections due to sharing of information or open the possibility of a joint inspection being performed. The key objectives of this initiative are:
To conduct periodic information exchanges on GCP-related information in order to streamline sharing of GCP inspection planning information, and to communicate timely and effectively on inspection outcomes.
To conduct collaborative GCP inspections by sharing information, experience, and inspection procedures, cooperating in the conduct of inspections, and sharing best-practice knowledge.
To share information on interpretation of GCP, by keeping each regulatory agency informed of GCP-related legislation, regulatory guidance and related documents, and act together to benefit the clinical research process.[1]
The collaborative effort will not only benefit inspectors from both agencies, but also the groups performing the clinical trials as well. The exchange of information will allow inspectors to become better informed with each organization’s inspection methods and styles; therefore, allowing the possibility to better educate the people responsible for performing the trials. At the end of the 18 months, the two agencies will evaluate the program’s success in achieving its goal of providing higher quality clinical trials.
This initiative could be the start of a more common practice among regulatory agencies. Although each agency has its own policies and procedures, they both remain rooted in the ideals of protecting patients and ensuring the highest quality of clinical trials. As the pharmaceutical industry develops new medicines, and additional developing countries begin participating in clinical trials, there is going to be an increasing need for quality inspection and oversight. A worldwide organization or panel governing clinical trial conduct may be closer than one would think.
Sources:
[1] United States. Food and Drug Administration. FDA, European Medicines Agency Launch Good Clinical Practices Initiative. 03 Aug 2009. Accessed on 19 Aug 2009.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm174983.htm
[2] European Union. European Medicines Agency. EMEA-FDA GCP Initiative. 31 Jul 2009. Accessed on 19 Aug 2009 http://www.emea.europa.eu/pdfs/general/direct/internationalcoop/EMEA_FDA_GCP_Initiative_2009.pdf
jondellaquila@cis-partners.com
On August 3, 2009, the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMEA) announced a collaborative initiative examining the conduct of clinical trials submitted in drug marketing applications. The pilot program, set to begin on September 1, 2009 and last for 18 months, will provide an opportunity for the two organizations to work together and allow for the sharing of information regarding good clinical practice (GCP) inspections conducted by the FDA and EMEA.[1] The intentions of the initiative will provide an open dialogue between the two organizations leading to a more efficient use of resources while improving the quality of clinical trials.
Facing a global economic recession, it is not surprising that some government agencies have begun assessing ideas to harmonize similar procedures. Currently, a large number of clinical trial participants come from the United States and the European Union - increasing the emphasis on why it may be important for these two organizations to work together. Since each agency operates with limited inspection resources, only a small sample of clinical trials can be inspected.[2] The scope of this program will allow for each organization to essentially double the number of inspections due to sharing of information or open the possibility of a joint inspection being performed. The key objectives of this initiative are:
To conduct periodic information exchanges on GCP-related information in order to streamline sharing of GCP inspection planning information, and to communicate timely and effectively on inspection outcomes.
To conduct collaborative GCP inspections by sharing information, experience, and inspection procedures, cooperating in the conduct of inspections, and sharing best-practice knowledge.
To share information on interpretation of GCP, by keeping each regulatory agency informed of GCP-related legislation, regulatory guidance and related documents, and act together to benefit the clinical research process.[1]
The collaborative effort will not only benefit inspectors from both agencies, but also the groups performing the clinical trials as well. The exchange of information will allow inspectors to become better informed with each organization’s inspection methods and styles; therefore, allowing the possibility to better educate the people responsible for performing the trials. At the end of the 18 months, the two agencies will evaluate the program’s success in achieving its goal of providing higher quality clinical trials.
This initiative could be the start of a more common practice among regulatory agencies. Although each agency has its own policies and procedures, they both remain rooted in the ideals of protecting patients and ensuring the highest quality of clinical trials. As the pharmaceutical industry develops new medicines, and additional developing countries begin participating in clinical trials, there is going to be an increasing need for quality inspection and oversight. A worldwide organization or panel governing clinical trial conduct may be closer than one would think.
Sources:
[1] United States. Food and Drug Administration. FDA, European Medicines Agency Launch Good Clinical Practices Initiative. 03 Aug 2009. Accessed on 19 Aug 2009.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm174983.htm
[2] European Union. European Medicines Agency. EMEA-FDA GCP Initiative. 31 Jul 2009. Accessed on 19 Aug 2009 http://www.emea.europa.eu/pdfs/general/direct/internationalcoop/EMEA_FDA_GCP_Initiative_2009.pdf
Wednesday, August 19, 2009
Sharing Prescription Drugs Frequent Among U.S. Teens
By: Kerri McCutchin, CIS Compliance Associate
kerrimccutchin@cis-partners.com
Prescription drug abuse by teens and young adults has spiraled into a serious issue in the United States. As reported in the Partnership for a Drug Free America’s annual tracking study:
The study, which appears online in the Journal of Adolescent Health, interviewed 592 English and Spanish speaking adolescents, ages 12 to 17, both black and white. The teens were asked if they had ever “borrowed” or “loaned” a prescription drug and, if so, what kind. The teens were also asked if they ever gave or received any warnings or instructions with the medication. Questions concerning outcomes were also raised, such as did the person taking the drugs visit a doctor anyway? Did side effects or allergic reactions occur [2]? Chris Mayhorn, an associate professor of psychology at North Carolina State University, states in a news release from the Center for the Advancement of Health:
According to lead author Richard Goldsworthy, Director for Research and Development at Academic Edge, Inc., and colleagues, the study found that nearly a third of teens who took a "borrowed" prescription did not inform their doctors. This type of situation can lead to unexpected drug interactions [1]. In addition to the risk of unforeseen side effects, prescription drug sharing can lead to a delay in teens addressing serious health care issues. Teens may skip necessary appointments believing they have already dealt with the problem. Moreover, the misuse of shared antibiotics enhances the increasing problem of antibiotic drug resistance [2].
The findings within the study are important "for physicians, prevention coalitions, school counselors, parents and the youth themselves," said Melissa Haddow, co-author of the study and director of the Community Partnership of the Ozarks. She continues by stating, "this work adds to our knowledge about a growing problem….and highlights the diversity of medications being abused this way, which had not been recognized.”
Sources:
[1] http://news.yahoo.com/s/hsn/20090810/hl_hsn/sharingprescriptionmedscommonamongusteens
[2] http://www.news-medical.net/news/20090810/Sharing-prescription-advice-among-adolescents-can-have-dangerous-repercussions.aspx
[3] http://www.drugfree.org/portal/drugissue/features/prescription_medicine_misuse
kerrimccutchin@cis-partners.com
Prescription drug abuse by teens and young adults has spiraled into a serious issue in the United States. As reported in the Partnership for a Drug Free America’s annual tracking study:
- 1 in 5 teens has abused a prescription (Rx) pain medication
- 1 in 5 report abusing prescription stimulants and tranquilizers
- 1 in 10 has abused cough medication [3]
The study, which appears online in the Journal of Adolescent Health, interviewed 592 English and Spanish speaking adolescents, ages 12 to 17, both black and white. The teens were asked if they had ever “borrowed” or “loaned” a prescription drug and, if so, what kind. The teens were also asked if they ever gave or received any warnings or instructions with the medication. Questions concerning outcomes were also raised, such as did the person taking the drugs visit a doctor anyway? Did side effects or allergic reactions occur [2]? Chris Mayhorn, an associate professor of psychology at North Carolina State University, states in a news release from the Center for the Advancement of Health:
"Other researchers have studied people selling prescription drugs, but we looked
at people with good intentions, trying, for instance, to help a friend who
lacked money or transportation for a doctor's visit" [1].
According to lead author Richard Goldsworthy, Director for Research and Development at Academic Edge, Inc., and colleagues, the study found that nearly a third of teens who took a "borrowed" prescription did not inform their doctors. This type of situation can lead to unexpected drug interactions [1]. In addition to the risk of unforeseen side effects, prescription drug sharing can lead to a delay in teens addressing serious health care issues. Teens may skip necessary appointments believing they have already dealt with the problem. Moreover, the misuse of shared antibiotics enhances the increasing problem of antibiotic drug resistance [2].
The findings within the study are important "for physicians, prevention coalitions, school counselors, parents and the youth themselves," said Melissa Haddow, co-author of the study and director of the Community Partnership of the Ozarks. She continues by stating, "this work adds to our knowledge about a growing problem….and highlights the diversity of medications being abused this way, which had not been recognized.”
Sources:
[1] http://news.yahoo.com/s/hsn/20090810/hl_hsn/sharingprescriptionmedscommonamongusteens
[2] http://www.news-medical.net/news/20090810/Sharing-prescription-advice-among-adolescents-can-have-dangerous-repercussions.aspx
[3] http://www.drugfree.org/portal/drugissue/features/prescription_medicine_misuse
Tuesday, August 18, 2009
Fact: The Color Blue Can Heal Spinal Injuries
By: Lauren Pellicciotti, CIS Compliance Manager
laurenpellicciotti@cis-partners.com
Prior to starting my full day at work, I like to enjoy a cup of Joe at my kitchen table while watching the morning news. Now you might be wondering how this might relate to health care industry news. Well, during my morning routine, I could not believe my ears when I heard that blue M&Ms and Gatorade could help people with long-term spinal injuries[1].
According to a study conducted by the University of Rochester Medical Center, the compound Brilliant Blue G can potentially prevent the cascade of events that leads to inflammation of the spine that usually is followed by a traumatic event[2]. According to Dr. Steven Goldman, who worked on the study, "We have no effective treatment now for patients who have an acute spinal cord injury. Our hope is that this work will lead to a practical, safe agent that can be given to patients shortly after injury, for the purpose of decreasing the secondary damage that we have to otherwise expect."
Proceedings of the National Academy of the Sciences states that inflammation can cause more irreversible damage than the initial trauma. Maiken Nedergaard of the University of Rochester Medical Center and colleagues reported that “One of the chemicals is ATP. Nedergaard's team looked for something that would interfere with this and found the blue dye, which they called BBG, would do this via the P2X7R receptor or doorway. The team found that IV administration of the P2X7R inhibitor BBG significantly reduced the severity of spinal cord damage without any evident toxicity. Remarkably, BBG is a derivative of the widely used food additive FD&C Blue number 1. Currently, more than 1 million pounds of FD&C blue dye No. 1 are consumed yearly in the United States, corresponding to a daily intake of 16 mg per person1.”
Knowing that small bit of information and the probability of this helping a person in need, I will definitely keep this information in my back pocket as a home remedy, as should you! If nothing else, a little chocolate might cheer you up.
Sources:
[1] Blue Food Dye Used in M&M's May Treat Spinal Cord Injuries: http://www.foxnews.com/story/0,2933,535142,00.html
[2] WebMD News: http://www.webmd.com/brain/news/20090729/blue-dye-mms-helps-spinal-cord-injuries
laurenpellicciotti@cis-partners.com
Prior to starting my full day at work, I like to enjoy a cup of Joe at my kitchen table while watching the morning news. Now you might be wondering how this might relate to health care industry news. Well, during my morning routine, I could not believe my ears when I heard that blue M&Ms and Gatorade could help people with long-term spinal injuries[1].
According to a study conducted by the University of Rochester Medical Center, the compound Brilliant Blue G can potentially prevent the cascade of events that leads to inflammation of the spine that usually is followed by a traumatic event[2]. According to Dr. Steven Goldman, who worked on the study, "We have no effective treatment now for patients who have an acute spinal cord injury. Our hope is that this work will lead to a practical, safe agent that can be given to patients shortly after injury, for the purpose of decreasing the secondary damage that we have to otherwise expect."
Proceedings of the National Academy of the Sciences states that inflammation can cause more irreversible damage than the initial trauma. Maiken Nedergaard of the University of Rochester Medical Center and colleagues reported that “One of the chemicals is ATP. Nedergaard's team looked for something that would interfere with this and found the blue dye, which they called BBG, would do this via the P2X7R receptor or doorway. The team found that IV administration of the P2X7R inhibitor BBG significantly reduced the severity of spinal cord damage without any evident toxicity. Remarkably, BBG is a derivative of the widely used food additive FD&C Blue number 1. Currently, more than 1 million pounds of FD&C blue dye No. 1 are consumed yearly in the United States, corresponding to a daily intake of 16 mg per person1.”
Knowing that small bit of information and the probability of this helping a person in need, I will definitely keep this information in my back pocket as a home remedy, as should you! If nothing else, a little chocolate might cheer you up.
Sources:
[1] Blue Food Dye Used in M&M's May Treat Spinal Cord Injuries: http://www.foxnews.com/story/0,2933,535142,00.html
[2] WebMD News: http://www.webmd.com/brain/news/20090729/blue-dye-mms-helps-spinal-cord-injuries
Thursday, August 13, 2009
Over-the-Counter
By: Jordan Mummau, CIS Compliance Associate
jordanmummau@cis-partners.com
To be honest, it took me until I was about 16 to figure out that over-the-counter drugs in any particular pharmacy were never really behind a counter to begin with. Back then, I assumed that a pharmacist had to hand you the product over a physical counter to be qualified as an over-the-counter drug (which is ironic because this would more closely describe the process for obtaining prescription drugs). Is this common? Unfortunately, I doubt it; I would assume most people understand the difference between the term “over-the-counter” and the act of physically passing something over a counter. At 16, I also seemed to share the more mainstream problem of understanding the difference between 10:00pm and 1:00am. I was told to be home at 10:00pm, which I naturally assumed was equivalent to 1:00am. But I digress…
I am pleased to announce that I have come a long way since then. I am older, debatably wiser, and more prone to balding and accidental falls. I am also able to wrap my head around the figurative over-the-counter process, having acquired an understanding of the FDA approval process drugs must go through in order to make it to pharmacy shelves.
The incentives of manufacturing over the counter (OTC) products versus prescription drugs are obvious. Manufacturers are able to market their products directly to consumers (DTC advertising), which allows for increased sales and profits[1]. This also alleviates extra spending on sales reps to visit and educate physicians on prescribing their medications, the side effects of these drugs, and ways to promote the drugs, all things pharmaceutical companies often have to do to foster awareness of their prescription drugs[2]. DTC advertising allows companies to lower the retail prices on their OTC drugs, and provides access to a larger market than physicians alone would be able to expose them to.
However, in order for a drug to be sold over the counter, it must meet the criteria established by the FDA. Over the years, the FDA has made amendment after amendment to the original Food, Drug, and Cosmetic Act of 1938, which was the first piece of legislation to require that drugs be cleared by the U.S. Food and Drug Administration before they could be marketed for human use. In 1951, an amendment was made to the Act which established the distinction between prescription and non-prescription drugs. In short, this amendment basically stated that if a drug product was unable to be labeled with accurate instructions on how to use it safely, it was to be available by prescription only. Another amendment was added in 1962, requiring OTC drugs to be effective for their intended uses[3].
In more recent years, the FDA has used a reclassification process in order to allow products previously indicated as prescription drugs to be sold as non-prescription drugs. There are three ways this change can be administered. (1) The FDA itself is allowed to file a petition for reclassification if it is determined that prescription status is not required for the safe use of the drug. (2) If new clinical research provides information that allows a drug to be approved for an OTC indication or at OTC dosage levels, a New Drug Application (NDA) may be filed by the manufacturer. (3) A supplement to the original NDA may be filed if favorable post marketing safety experience for a product provides evidence that the drug product may be safely used without the supervision of a physician[4].
While there are also several specific drug approval regulations, including formulation, chronic treatments, etc., hopefully this article will assist you in understanding that the phrase over-the-counter should not necessarily be taken literally.
Three OTC Quick Facts[5]:
[1] Dessen, Moses, and Rossitto. "Information About Over-The-Counter Drugs Malpractice." DMS-Lawyers. 28 May 2006. Web. 31 July 2009. http://www.dms-lawyer.com/area/otc.shtml
[2] Dessen, Moses, and Rossitto. "Information About Over-The-Counter Drugs Malpractice." DMS-Lawyers. 28 May 2006. Web. 31 July 2009. http://www.dms-lawyer.com/area/otc.shtml
[3] Jacobs, Lori R. "Prescription to Over-the-Counter Drug Reclassification." American Family Physician. The Medicine Shoppe. Web. 31 July 2009. http://www.aafp.org/afp/980501ap/jacobs.html
[4] Jacobs, Lori R. "Prescription to Over-the-Counter Drug Reclassification." American Family Physician. The Medicine Shoppe. Web. 31 July 2009. http://www.aafp.org/afp/980501ap/jacobs.html
[5] Jacobs, Lori R. "Prescription to Over-the-Counter Drug Reclassification." American Family Physician. The Medicine Shoppe. Web. 31 July 2009. http://www.aafp.org/afp/980501ap/jacobs.html
Additional Sources:
Cohen, Joshua P., Cherie Paquette, and Catherine P. Cairns. "Switching Prescription Drugs to Over-the-Counter." BMJ. 1 Jan. 2005. Web. 31 July 2009. http://www.bmj.com/cgi/content/full/330/7481/39
"Office of Nonprescription Products." FDA US Food and Drug Administration. U.S. Department of Health and Human Services. Web. 31 July 2009. http://www.fda.gov/AboutFDA/CentersOffices/cder/ucm093452.htm
jordanmummau@cis-partners.com
To be honest, it took me until I was about 16 to figure out that over-the-counter drugs in any particular pharmacy were never really behind a counter to begin with. Back then, I assumed that a pharmacist had to hand you the product over a physical counter to be qualified as an over-the-counter drug (which is ironic because this would more closely describe the process for obtaining prescription drugs). Is this common? Unfortunately, I doubt it; I would assume most people understand the difference between the term “over-the-counter” and the act of physically passing something over a counter. At 16, I also seemed to share the more mainstream problem of understanding the difference between 10:00pm and 1:00am. I was told to be home at 10:00pm, which I naturally assumed was equivalent to 1:00am. But I digress…
I am pleased to announce that I have come a long way since then. I am older, debatably wiser, and more prone to balding and accidental falls. I am also able to wrap my head around the figurative over-the-counter process, having acquired an understanding of the FDA approval process drugs must go through in order to make it to pharmacy shelves.
The incentives of manufacturing over the counter (OTC) products versus prescription drugs are obvious. Manufacturers are able to market their products directly to consumers (DTC advertising), which allows for increased sales and profits[1]. This also alleviates extra spending on sales reps to visit and educate physicians on prescribing their medications, the side effects of these drugs, and ways to promote the drugs, all things pharmaceutical companies often have to do to foster awareness of their prescription drugs[2]. DTC advertising allows companies to lower the retail prices on their OTC drugs, and provides access to a larger market than physicians alone would be able to expose them to.
However, in order for a drug to be sold over the counter, it must meet the criteria established by the FDA. Over the years, the FDA has made amendment after amendment to the original Food, Drug, and Cosmetic Act of 1938, which was the first piece of legislation to require that drugs be cleared by the U.S. Food and Drug Administration before they could be marketed for human use. In 1951, an amendment was made to the Act which established the distinction between prescription and non-prescription drugs. In short, this amendment basically stated that if a drug product was unable to be labeled with accurate instructions on how to use it safely, it was to be available by prescription only. Another amendment was added in 1962, requiring OTC drugs to be effective for their intended uses[3].
In more recent years, the FDA has used a reclassification process in order to allow products previously indicated as prescription drugs to be sold as non-prescription drugs. There are three ways this change can be administered. (1) The FDA itself is allowed to file a petition for reclassification if it is determined that prescription status is not required for the safe use of the drug. (2) If new clinical research provides information that allows a drug to be approved for an OTC indication or at OTC dosage levels, a New Drug Application (NDA) may be filed by the manufacturer. (3) A supplement to the original NDA may be filed if favorable post marketing safety experience for a product provides evidence that the drug product may be safely used without the supervision of a physician[4].
While there are also several specific drug approval regulations, including formulation, chronic treatments, etc., hopefully this article will assist you in understanding that the phrase over-the-counter should not necessarily be taken literally.
Three OTC Quick Facts[5]:
- Non-prescription drugs account for 60 percent of all medications used in the United States.
- Criteria that allow a prescription drug to be reclassified as an OTC drug include the following: similar indications for both prescription and nonprescription uses, easy diagnosis and monitoring by the patient, and favorable adverse-effect and drug-interaction profiles.
- Switching a product from prescription to over-the-counter status permits the drug manufacturer to market the product for several more years without generic competition.
[1] Dessen, Moses, and Rossitto. "Information About Over-The-Counter Drugs Malpractice." DMS-Lawyers. 28 May 2006. Web. 31 July 2009. http://www.dms-lawyer.com/area/otc.shtml
[2] Dessen, Moses, and Rossitto. "Information About Over-The-Counter Drugs Malpractice." DMS-Lawyers. 28 May 2006. Web. 31 July 2009. http://www.dms-lawyer.com/area/otc.shtml
[3] Jacobs, Lori R. "Prescription to Over-the-Counter Drug Reclassification." American Family Physician. The Medicine Shoppe. Web. 31 July 2009. http://www.aafp.org/afp/980501ap/jacobs.html
[4] Jacobs, Lori R. "Prescription to Over-the-Counter Drug Reclassification." American Family Physician. The Medicine Shoppe. Web. 31 July 2009. http://www.aafp.org/afp/980501ap/jacobs.html
[5] Jacobs, Lori R. "Prescription to Over-the-Counter Drug Reclassification." American Family Physician. The Medicine Shoppe. Web. 31 July 2009. http://www.aafp.org/afp/980501ap/jacobs.html
Additional Sources:
Cohen, Joshua P., Cherie Paquette, and Catherine P. Cairns. "Switching Prescription Drugs to Over-the-Counter." BMJ. 1 Jan. 2005. Web. 31 July 2009. http://www.bmj.com/cgi/content/full/330/7481/39
"Office of Nonprescription Products." FDA US Food and Drug Administration. U.S. Department of Health and Human Services. Web. 31 July 2009. http://www.fda.gov/AboutFDA/CentersOffices/cder/ucm093452.htm
Wednesday, August 12, 2009
The Definition of Indecent Could Become Ridiculous
By: Judy Fox, CIS Senior Compliance Manager
judyfox@cis-partners.com
On April 29, 2009 State Representative James P. Moran of Virginia introduced a bill – H.R. 2175 into the House of Representatives with the official title, “To prohibit as indecent the broadcasting of any advertisement for a medication for the treatment of erectile dysfunction[ED], and for other purposes.” The short title for the bill as it was introduced is the “Families for ED Advertising Decency Act.” The bill is co-sponsored by Representative Robert A. Brady of Pennsylvania. The title of the bill alone sounded a little ridiculous, but I had to read it to make sure. The bill is not lengthy or wordy, nor does it contain a lot of legal terminology, yet to me, the content is just as confusing.
The bill asks that the Federal Communications Commission (FCC) revise the enforcement policies relating to indecent material so that radio and television stations would be prohibited from broadcasting any advertisements for ED any day between 6am and 10 pm. The bill asks that stations treat all advertisements for ED medication as indecent. Yup, that’s right, INDECENT. The restriction would not include product placement, or the mention of the trademarked or generic name for an ED medication.
There is a possibility that I am missing something, but is the reason why all ads for ED medications are being deemed indecent is because ED is a medical condition that has to do with male genitalia? Or is it because the only reason to take the medication is to have sex? Either way, I find it ridiculous to define indecent in this way.
I tried to recall the ads I have seen for these products and could not remember ever seeing one that I felt was even inappropriate, let alone indecent. I did recall some that were confusing. I remember one in particular where a couple was sitting in separate outdoor bathtubs overlooking the beach. I found it a bit silly, but certainly not indecent. I didn’t want to rely on my memory alone, so I did a little unscientific research. The ads I found showed what appeared to be monogamous couples, usually appearing to be in their 50’s, smiling at each other, dancing, and, in general, enjoying each other. I couldn’t find a single ad that featured people having sex. None of the ads I viewed (in my very unscientific research) did more than imply the indication of the medication. There was the often joked about four hour erection warning, but most direct to consumer (DTC) advertising can cause one to cringe when the possible side effects are rattled off anyway.
The only thing I could conclude was that the indication for these medications must be the cause behind labeling the ads as ‘indecent’. It may be news to Representatives Moran and Brady, but I think I can speak for most couples when I say that sex is a healthy part of a relationship. I can’t find anything indecent about the fact that there are plenty of men who have a medical condition that keep them from being able to enjoy sex with their partners. Many sufferers are embarrassed to seek help for the condition, and labeling the advertisements offering them help as indecent could make them feel even worse. Removing the stigma associated with the problem has made it easier for men to seek help from their doctors and avoid purchasing knock-offs and questionable products through mail order companies.
Furthermore, pharmaceutical marketing teams work hard to target DTC advertising to the appropriate audiences, and place their advertisements during programs that appeal to those target audiences. As such, ED ads are not aired during children’s programming, or during programs that target teen audiences. If the representatives are worried about decency, they should concentrate on ad placement in general, or, and this is a novel concept, on the content of the programming itself. For example, when my sons were young, I remember actually getting angry at the commercials for R-rated movies that were aired during family programming. I would consider that inappropriate, not indecent mind you, just inappropriate and possibly worth looking into. I think we have so many more important issues to worry about before we should target happy, dancing couples.
The way the bill reads, it would be acceptable for a television program to make Viagra® jokes, have Cialis® logos plastered all over the side of a car, or feature Levitra® as a sponsor, but there couldn’t be a commercial for those products during the same program. Ridiculous. What’s next? Banning ads for birth-control pills? After all, these politicians might erroneously reason, only women who have sex need the Pill.
Sources:
http://thomas.loc.gov/cgi-bin/bdquery/D?d111:14:./temp/~bdQWzr:@@@T
www.viagra.com
www.levitra.com
www.cialis.com
judyfox@cis-partners.com
On April 29, 2009 State Representative James P. Moran of Virginia introduced a bill – H.R. 2175 into the House of Representatives with the official title, “To prohibit as indecent the broadcasting of any advertisement for a medication for the treatment of erectile dysfunction[ED], and for other purposes.” The short title for the bill as it was introduced is the “Families for ED Advertising Decency Act.” The bill is co-sponsored by Representative Robert A. Brady of Pennsylvania. The title of the bill alone sounded a little ridiculous, but I had to read it to make sure. The bill is not lengthy or wordy, nor does it contain a lot of legal terminology, yet to me, the content is just as confusing.
The bill asks that the Federal Communications Commission (FCC) revise the enforcement policies relating to indecent material so that radio and television stations would be prohibited from broadcasting any advertisements for ED any day between 6am and 10 pm. The bill asks that stations treat all advertisements for ED medication as indecent. Yup, that’s right, INDECENT. The restriction would not include product placement, or the mention of the trademarked or generic name for an ED medication.
There is a possibility that I am missing something, but is the reason why all ads for ED medications are being deemed indecent is because ED is a medical condition that has to do with male genitalia? Or is it because the only reason to take the medication is to have sex? Either way, I find it ridiculous to define indecent in this way.
I tried to recall the ads I have seen for these products and could not remember ever seeing one that I felt was even inappropriate, let alone indecent. I did recall some that were confusing. I remember one in particular where a couple was sitting in separate outdoor bathtubs overlooking the beach. I found it a bit silly, but certainly not indecent. I didn’t want to rely on my memory alone, so I did a little unscientific research. The ads I found showed what appeared to be monogamous couples, usually appearing to be in their 50’s, smiling at each other, dancing, and, in general, enjoying each other. I couldn’t find a single ad that featured people having sex. None of the ads I viewed (in my very unscientific research) did more than imply the indication of the medication. There was the often joked about four hour erection warning, but most direct to consumer (DTC) advertising can cause one to cringe when the possible side effects are rattled off anyway.
The only thing I could conclude was that the indication for these medications must be the cause behind labeling the ads as ‘indecent’. It may be news to Representatives Moran and Brady, but I think I can speak for most couples when I say that sex is a healthy part of a relationship. I can’t find anything indecent about the fact that there are plenty of men who have a medical condition that keep them from being able to enjoy sex with their partners. Many sufferers are embarrassed to seek help for the condition, and labeling the advertisements offering them help as indecent could make them feel even worse. Removing the stigma associated with the problem has made it easier for men to seek help from their doctors and avoid purchasing knock-offs and questionable products through mail order companies.
Furthermore, pharmaceutical marketing teams work hard to target DTC advertising to the appropriate audiences, and place their advertisements during programs that appeal to those target audiences. As such, ED ads are not aired during children’s programming, or during programs that target teen audiences. If the representatives are worried about decency, they should concentrate on ad placement in general, or, and this is a novel concept, on the content of the programming itself. For example, when my sons were young, I remember actually getting angry at the commercials for R-rated movies that were aired during family programming. I would consider that inappropriate, not indecent mind you, just inappropriate and possibly worth looking into. I think we have so many more important issues to worry about before we should target happy, dancing couples.
The way the bill reads, it would be acceptable for a television program to make Viagra® jokes, have Cialis® logos plastered all over the side of a car, or feature Levitra® as a sponsor, but there couldn’t be a commercial for those products during the same program. Ridiculous. What’s next? Banning ads for birth-control pills? After all, these politicians might erroneously reason, only women who have sex need the Pill.
Sources:
http://thomas.loc.gov/cgi-bin/bdquery/D?d111:14:./temp/~bdQWzr:@@@T
www.viagra.com
www.levitra.com
www.cialis.com
Friday, August 7, 2009
My name is Steven P. Moore and I haven’t smoked in 5 years.
By: Steven Moore, CIS Director of Business Development
stevenmoore@cis-partners.com
Given the industry we work in, I thought that this topic was pertinent. I thank you in advance for reading my story.
I was recently at a gas station in my hometown of Belford, NJ and saw a sign for Newport cigarettes. They were selling for $6.66. I snapped a picture with my cell phone and had planned on using it for this blog article, but my phone zonked out recently and I lost the photo. So I’ll allow you to imagine the fun irony of putting that price tag on a pack of cigarettes…
On August 22, 2004, my wife-to-be and girlfriend at the time, brought over a bag full of goodies. But these weren’t just any goodies --- the bag contained just about every possible quit smoking aid that she could research: Twizzlers, lollipops, toothpicks, etc. The bag was overflowing. She had never asked me to quit but let’s be honest, who wants to kiss a smoker and who wants someone that you care about to smoke?
I had set my quit date for August 23, 2004 a couple months earlier. I think if there is one event that prompted me to say enough is enough (besides wanting to do it for my health and for my wife-to-be) it was a ‘date’ that we had a couple months prior. We had been going out for a month or two and went for a LONG run at Fairmount Park in Philadelphia. I had smoked since I was about 18 and at that time, at 25, this was no joy run for me! But, being the man that I am, I ran with a smile and as soon as I could find a quiet place to cough up a lung…I did so! The saddest part was that I was somewhat of an athlete through high school and college --- but it was clear now that 7 years of coffin nails were starting to take their toll.
So the morning of August 23rd came and I drove into work with my coffee and, for the first time in 5 years, did not have a cigarette. Now here’s one of the more ironic and twisted stories I’ve ever been able to re-tell. As I was driving in that morning, there was a road crew on a local road near my work that was ‘re-tarring’ the road. The crew waived me through and I thought I’d be fine. Well, the tar was still wet and splashed all over my car. So the two pieces of irony are, on the day I intended to quit smoking: 1) My car was covered in TAR. 2) I had an event happen that would usually make me reach for a pack of cigarettes --- not just one. I didn’t smoke then and haven’t smoked since.
My wife recently asked me, “What’s the best part about not smoking?” I didn’t hesitate when I answered, “You know, it’s when we go for our daily runs together and I pass someone on a bench who is smoking.” That may sound strange, but I think when you’re doing something so fundamentally opposite to something harmful, it’s an invigorating feeling. Of course I feel for those who still smoke as I breeze past, but I’m thankful for getting the strength from God, family and friends to get through it.
Quitting smoking was the best decision I’ve ever made, next to asking my wife for her hand in marriage and joining CIS (what a kiss up!). For those of you who are smoking and want to quit, know that you CAN do it. It is possible, and when you do quit, you will feel amazing. Your fingers go from yellow to normal. Your teeth get whiter. You can run. You can keep up with your kids. You can dance. You can hike. You can imagine a future without coughing every morning and every time you run up stairs. You can be proud of it. You can (and should) tell everyone. You can write an article like this one day. You can say that you’re stronger than a tobacco-filled piece of paper.
You can use the gum, the patch, medicine, etc. But I can guarantee you this: The strongest quit smoking aid is your own will power. Remember back to a time when there was something you wanted so badly and you achieved it. Remember how you felt. Find that power and voice and I’m certain you can quit! I registered on www.njquitnet.com, a fantastic site for assistance, and they keep a running tab of certain key stats. As of me typing this article, these were my stats:
My Stats:
Your Quit Date is: 8/23/2004 1:30:00 PM
Time Smoke-Free: 1,805 days, 21 hours, 52 minutes and 32 seconds
Cigarettes NOT smoked: 36,118
Lifetime Saved: 9 months, 5 days, 21 hours
Money Saved: $7,314.30
More than 36,000 cigarettes! Wow! My efforts have allowed me 9 more months of life to breathe, to be with my wife and, God-willing, children and grandchildren. The amount of MONEY that I saved has paid for 3 vacations --- including our honeymoon! What can you do with $7,314.30 over the course of 5 years?
My lone wish in writing this article is that it may just inspire one person to put the cigarettes down and go for it. This isn’t about me bragging about what I’ve been able to do --- it’s about trying to help through words and, for the first time in my life, I have a public forum to do so! I went through it and understand the strength it takes and the feelings you’ll experience. Heck, if this makes you want to quit, call or email me when you’re struggling and I’ll have your back. Do it with a loved one or a friend who wants to quit with you or cares for you. They’ll help. They’ll take walks with you. They’ll stay on the phone with you. They’ll give you a hug when it hurts. They’ll break a cigarette in half and flush it.
And, if you’re lucky enough, they might even bring you a bag overflowing with quit-smoking aids to help you quit.
No wonder my username on NJ Quitnet is:
Quit4Her.
I thank you and love you Noreen.
For your space,
Steven.
stevenmoore@cis-partners.com
Given the industry we work in, I thought that this topic was pertinent. I thank you in advance for reading my story.
I was recently at a gas station in my hometown of Belford, NJ and saw a sign for Newport cigarettes. They were selling for $6.66. I snapped a picture with my cell phone and had planned on using it for this blog article, but my phone zonked out recently and I lost the photo. So I’ll allow you to imagine the fun irony of putting that price tag on a pack of cigarettes…
On August 22, 2004, my wife-to-be and girlfriend at the time, brought over a bag full of goodies. But these weren’t just any goodies --- the bag contained just about every possible quit smoking aid that she could research: Twizzlers, lollipops, toothpicks, etc. The bag was overflowing. She had never asked me to quit but let’s be honest, who wants to kiss a smoker and who wants someone that you care about to smoke?
I had set my quit date for August 23, 2004 a couple months earlier. I think if there is one event that prompted me to say enough is enough (besides wanting to do it for my health and for my wife-to-be) it was a ‘date’ that we had a couple months prior. We had been going out for a month or two and went for a LONG run at Fairmount Park in Philadelphia. I had smoked since I was about 18 and at that time, at 25, this was no joy run for me! But, being the man that I am, I ran with a smile and as soon as I could find a quiet place to cough up a lung…I did so! The saddest part was that I was somewhat of an athlete through high school and college --- but it was clear now that 7 years of coffin nails were starting to take their toll.
So the morning of August 23rd came and I drove into work with my coffee and, for the first time in 5 years, did not have a cigarette. Now here’s one of the more ironic and twisted stories I’ve ever been able to re-tell. As I was driving in that morning, there was a road crew on a local road near my work that was ‘re-tarring’ the road. The crew waived me through and I thought I’d be fine. Well, the tar was still wet and splashed all over my car. So the two pieces of irony are, on the day I intended to quit smoking: 1) My car was covered in TAR. 2) I had an event happen that would usually make me reach for a pack of cigarettes --- not just one. I didn’t smoke then and haven’t smoked since.
My wife recently asked me, “What’s the best part about not smoking?” I didn’t hesitate when I answered, “You know, it’s when we go for our daily runs together and I pass someone on a bench who is smoking.” That may sound strange, but I think when you’re doing something so fundamentally opposite to something harmful, it’s an invigorating feeling. Of course I feel for those who still smoke as I breeze past, but I’m thankful for getting the strength from God, family and friends to get through it.
Quitting smoking was the best decision I’ve ever made, next to asking my wife for her hand in marriage and joining CIS (what a kiss up!). For those of you who are smoking and want to quit, know that you CAN do it. It is possible, and when you do quit, you will feel amazing. Your fingers go from yellow to normal. Your teeth get whiter. You can run. You can keep up with your kids. You can dance. You can hike. You can imagine a future without coughing every morning and every time you run up stairs. You can be proud of it. You can (and should) tell everyone. You can write an article like this one day. You can say that you’re stronger than a tobacco-filled piece of paper.
You can use the gum, the patch, medicine, etc. But I can guarantee you this: The strongest quit smoking aid is your own will power. Remember back to a time when there was something you wanted so badly and you achieved it. Remember how you felt. Find that power and voice and I’m certain you can quit! I registered on www.njquitnet.com, a fantastic site for assistance, and they keep a running tab of certain key stats. As of me typing this article, these were my stats:
My Stats:
Your Quit Date is: 8/23/2004 1:30:00 PM
Time Smoke-Free: 1,805 days, 21 hours, 52 minutes and 32 seconds
Cigarettes NOT smoked: 36,118
Lifetime Saved: 9 months, 5 days, 21 hours
Money Saved: $7,314.30
More than 36,000 cigarettes! Wow! My efforts have allowed me 9 more months of life to breathe, to be with my wife and, God-willing, children and grandchildren. The amount of MONEY that I saved has paid for 3 vacations --- including our honeymoon! What can you do with $7,314.30 over the course of 5 years?
My lone wish in writing this article is that it may just inspire one person to put the cigarettes down and go for it. This isn’t about me bragging about what I’ve been able to do --- it’s about trying to help through words and, for the first time in my life, I have a public forum to do so! I went through it and understand the strength it takes and the feelings you’ll experience. Heck, if this makes you want to quit, call or email me when you’re struggling and I’ll have your back. Do it with a loved one or a friend who wants to quit with you or cares for you. They’ll help. They’ll take walks with you. They’ll stay on the phone with you. They’ll give you a hug when it hurts. They’ll break a cigarette in half and flush it.
And, if you’re lucky enough, they might even bring you a bag overflowing with quit-smoking aids to help you quit.
No wonder my username on NJ Quitnet is:
Quit4Her.
I thank you and love you Noreen.
For your space,
Steven.
Monday, August 3, 2009
Is Pay-for-Delay Here to Stay?
By: Kyle Hodgin, CIS Compliance Associate
kylehodgin@cis-partners.com
In a blow to consumer rights activists and insurance companies, the Supreme Court recently declined to hear a case concerning the pay-for-delay practices made possible under the Hatch-Waxman Act of 1984. The absence of a ruling by the high court translates into secured profitability for branded pharmaceutical manufacturers, and possibly slower availability of generic alternatives to branded drugs for consumers. The decision by the courts to pass on hearing the case perpetuates the existing system under the Act and continues to raise questions in the minds of lobbyists and consumers alike such as; does the public have a right to cheaper generic drugs, and do manufacturers have a right to prolong protection of proprietary materials and information in light of increasing costs for branded meds?
The so-called, “pay-for-delay” practice has become a divisive issue between manufacturers and consumer activists. The practice involves a payment from branded drug makers to generic manufacturers to simply hold off on production as an alternative to enduring patent infringement litigation. The deal provides the generic companies with a substantial amount of cash with relatively little expenditure and the branded makers with a prolonged period of exclusive market share for that particular product. Critics cite the practice as anticompetitive as it prevents other generic manufacturers from entering the market. The Hatch-Waxman Act allows the first generic manufacturer to win FDA approval, for a generic version of a branded drug, 180 days of exclusivity. This provision was intended to incentivize competing generic makers to invest in the necessary tests to achieve bio-equivalency with assurance of recuperating those costs once the drug was approved. However, branded manufacturers have instead offered cash incentives to these generic companies to refrain from bringing the product to market for a specified period of time, in which case other generic companies are unable to obtain FDA approval for that particular product.
The payments, called reverse settlements, have insurance companies and consumer groups on edge, because they view the agreements as collusion, ultimately ending in a significantly higher price to the consumer; however, some generic drug makers and branded companies claim the agreements have multiple benefits to companies and consumers alike. When generic firms apply for an Abbreviated New Drug Application (ANDA), they are required to establish that the patent for the branded product is expired or invalid, and to notify the patent holder of the submission of the ANDA. Under the Act, branded companies are able to file a patent infringement suit within 45 days of the submission of the ANDA, and consequently, the courts must immediately enact a stay of up to 30 months to review the patent and determine if any infringement has occurred, during which time the generic firm may not market the contested product. This may effectively provide the branded manufacturer with up to two and a half additional years of exclusive market share that far outweighs the cost of infringement litigation. During the initial stay, the company has the opportunity to file a secondary patent on the original drug that, if granted, provides another opportunity for the manufacturer to file an infringement suit against the generic maker, thereby opening the door for further stays perpetuating exclusive marketing rights for the branded maker. The reverse settlement agreement is viewed as a means to avoid litigation, which can be costly for generic manufacturers as they often do not possess the same financial means as their branded counterparts. By not continuing the litigation, branded and generic firms can possibly bypass the lengthy stays that are enacted while the courts decide on the infringement suit.
Branded drug companies also cite the agreement as another method to protect property that took years, and tremendous amounts of capital, to develop. With the cost of bringing a single successful drug to market hovering around 800 million dollars and 8-12 years of development, manufacturers look to plow a significant portion of earnings from their branded products into research and development budgets. Some are concerned that further attempts to redefine patent laws will see a shortage in these crucial investments that could ultimately lead to a lesser quality of life for the general public in years to come. The Supreme Court’s decision to pass on hearing the latest case involving pay-to-delay practices means consumer groups and insurance companies may have to look to reform of the Hatch-Waxman Act or a change in patent laws to effectively bring an end to this practice.
Sources:
http://www.fiercepharma.com/story/supremes-wont-revew-pay-delay-case/2009-06-23
http://knowledge.wharton.upenn.edu/article.cfm?articleid=575
http://www.law.duke.edu/journals/dltr/articles/2003dltr0018.html
http://www.unav.es/english/news/105.html
kylehodgin@cis-partners.com
In a blow to consumer rights activists and insurance companies, the Supreme Court recently declined to hear a case concerning the pay-for-delay practices made possible under the Hatch-Waxman Act of 1984. The absence of a ruling by the high court translates into secured profitability for branded pharmaceutical manufacturers, and possibly slower availability of generic alternatives to branded drugs for consumers. The decision by the courts to pass on hearing the case perpetuates the existing system under the Act and continues to raise questions in the minds of lobbyists and consumers alike such as; does the public have a right to cheaper generic drugs, and do manufacturers have a right to prolong protection of proprietary materials and information in light of increasing costs for branded meds?
The so-called, “pay-for-delay” practice has become a divisive issue between manufacturers and consumer activists. The practice involves a payment from branded drug makers to generic manufacturers to simply hold off on production as an alternative to enduring patent infringement litigation. The deal provides the generic companies with a substantial amount of cash with relatively little expenditure and the branded makers with a prolonged period of exclusive market share for that particular product. Critics cite the practice as anticompetitive as it prevents other generic manufacturers from entering the market. The Hatch-Waxman Act allows the first generic manufacturer to win FDA approval, for a generic version of a branded drug, 180 days of exclusivity. This provision was intended to incentivize competing generic makers to invest in the necessary tests to achieve bio-equivalency with assurance of recuperating those costs once the drug was approved. However, branded manufacturers have instead offered cash incentives to these generic companies to refrain from bringing the product to market for a specified period of time, in which case other generic companies are unable to obtain FDA approval for that particular product.
The payments, called reverse settlements, have insurance companies and consumer groups on edge, because they view the agreements as collusion, ultimately ending in a significantly higher price to the consumer; however, some generic drug makers and branded companies claim the agreements have multiple benefits to companies and consumers alike. When generic firms apply for an Abbreviated New Drug Application (ANDA), they are required to establish that the patent for the branded product is expired or invalid, and to notify the patent holder of the submission of the ANDA. Under the Act, branded companies are able to file a patent infringement suit within 45 days of the submission of the ANDA, and consequently, the courts must immediately enact a stay of up to 30 months to review the patent and determine if any infringement has occurred, during which time the generic firm may not market the contested product. This may effectively provide the branded manufacturer with up to two and a half additional years of exclusive market share that far outweighs the cost of infringement litigation. During the initial stay, the company has the opportunity to file a secondary patent on the original drug that, if granted, provides another opportunity for the manufacturer to file an infringement suit against the generic maker, thereby opening the door for further stays perpetuating exclusive marketing rights for the branded maker. The reverse settlement agreement is viewed as a means to avoid litigation, which can be costly for generic manufacturers as they often do not possess the same financial means as their branded counterparts. By not continuing the litigation, branded and generic firms can possibly bypass the lengthy stays that are enacted while the courts decide on the infringement suit.
Branded drug companies also cite the agreement as another method to protect property that took years, and tremendous amounts of capital, to develop. With the cost of bringing a single successful drug to market hovering around 800 million dollars and 8-12 years of development, manufacturers look to plow a significant portion of earnings from their branded products into research and development budgets. Some are concerned that further attempts to redefine patent laws will see a shortage in these crucial investments that could ultimately lead to a lesser quality of life for the general public in years to come. The Supreme Court’s decision to pass on hearing the latest case involving pay-to-delay practices means consumer groups and insurance companies may have to look to reform of the Hatch-Waxman Act or a change in patent laws to effectively bring an end to this practice.
Sources:
http://www.fiercepharma.com/story/supremes-wont-revew-pay-delay-case/2009-06-23
http://knowledge.wharton.upenn.edu/article.cfm?articleid=575
http://www.law.duke.edu/journals/dltr/articles/2003dltr0018.html
http://www.unav.es/english/news/105.html
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