Politics and the FDA
Mar/26/09 10:50
With the election of Barack Obama, many believe that there would be a change in healthcare policy, reversing some of the policies of his predecessor. I had discussed some of the predicted changes several times recently. Additionally, with the appointment of a new FDA Commissioner, Margaret A. Hamburg, I was becoming confident that the FDA would become an advocate for consumers and industry, and that many of the more egregious political decisions that harmed the medical products industry would be overturned or modified. It is clear that the change would be take time because of the many priorities in the new Obama administration, but decisions such as the executive order clearing the way for research using embryonic stem cells are moving medicine and science in a healthy direction.
I personally object to political considerations taking priority for science and medicine. It’s a waste of money, it places undue burdens on both the medical products industry and the agencies that regulate them, and it increases the amount of time to get products onto the market. In addition, it allows foreign companies, whose regulatory agencies may not have these egregious political issues, to bring to market products that help their citizens. In some cases, foreign subsidiaries of US companies provide newer products to residents of those countries than they do for US residents.
Plan B, an emergency contraception drug, composed of two (levonorgestrel, 0.75 mg) progestin-only tablets, was approved by the FDA in 1999 and is currently still the only emergency contraception drug approved. Plan B is not RU-486 (mifepristone), also known as the abortion pill, since Plan B cannot terminate a pregnancy, just prevent it. Additionally, Plan B does not require a prescription to obtain. In August 2006, the FDA restricted sale of the drug to women 18 years or older. Women 17 years or younger could only obtain the drug by prescription from a physician. The intent of this labeling change was to restrict minors from easily obtaining the drug, although I am unconvinced as to ruling’s effectiveness.
This week, Judge Edward R Korman, a United States District Judge for the District of Eastern New York, ordered the FDA to allow 17 year olds to obtain Plan B in the same manner as other women. Essentially, Judge Korman stated that the FDA restricted the availability of Plan B without any scientific or medical basis, probably as a result of pressure from the Bush administration.
Korman’s ruling actually blasted the FDA on a number of points:
In other words, the FDA took political expediency rather than sound medical and scientific review to change the availability of the drug. The Judge then proceeded to attack the interference from politically appointed commissioners in the decision process:
Medical products should be available to citizens because they are safe and efficacious, not to set social policy. I trust the NIH and the FDA on scientific matters. It’s important that science remains their focus.
By Michael W Simpson
I personally object to political considerations taking priority for science and medicine. It’s a waste of money, it places undue burdens on both the medical products industry and the agencies that regulate them, and it increases the amount of time to get products onto the market. In addition, it allows foreign companies, whose regulatory agencies may not have these egregious political issues, to bring to market products that help their citizens. In some cases, foreign subsidiaries of US companies provide newer products to residents of those countries than they do for US residents.
Plan B, an emergency contraception drug, composed of two (levonorgestrel, 0.75 mg) progestin-only tablets, was approved by the FDA in 1999 and is currently still the only emergency contraception drug approved. Plan B is not RU-486 (mifepristone), also known as the abortion pill, since Plan B cannot terminate a pregnancy, just prevent it. Additionally, Plan B does not require a prescription to obtain. In August 2006, the FDA restricted sale of the drug to women 18 years or older. Women 17 years or younger could only obtain the drug by prescription from a physician. The intent of this labeling change was to restrict minors from easily obtaining the drug, although I am unconvinced as to ruling’s effectiveness.
This week, Judge Edward R Korman, a United States District Judge for the District of Eastern New York, ordered the FDA to allow 17 year olds to obtain Plan B in the same manner as other women. Essentially, Judge Korman stated that the FDA restricted the availability of Plan B without any scientific or medical basis, probably as a result of pressure from the Bush administration.
Korman’s ruling actually blasted the FDA on a number of points:
The FDA considered the Citizen Petition in tandem with a number of proposals – referred to as supplemental new drug applications (“SNDA”) – submitted by Women’s Capital Corporation, the drug’s original manufacturer. Women’s Capital Corporation sold its right to market Plan B to Barr Pharmaceuticals, Inc. during the course of the proceedings described below. I refer to them collectively as the “Plan B sponsor.” The first SNDA, like the Citizen Petition, sought non-prescription access to Plan B for women of all ages. After the FDA denied such access, the Plan B sponsor submitted a second SNDA, seeking non-prescription access for women 16 and older. The FDA rejected that application too despite nearly uniform agreement among FDA scientific review staff that women of all ages could use Plan B without a prescription safely and effectively. The Plan B sponsor then submitted a third SNDA, which proposed making Plan B available without a prescription to women 17 and older. While FDA scientists and senior officials found that 17 year olds could use Plan B safely without a prescription, the FDA Commissioner determined that, because of “enforcement” concerns, Plan B would be available without a prescription only to women 18 and older. Putting aside for the moment the specifics of the many claims brought by plaintiffs and the details of each of the FDA’s decisions, the gravamen of plaintiffs’ claims is that the FDA’s decisions regarding Plan B – on the Citizen Petition and the SNDAs – were arbitrary and capricious because they were not the result of reasoned and good faith agency decision-making.
In other words, the FDA took political expediency rather than sound medical and scientific review to change the availability of the drug. The Judge then proceeded to attack the interference from politically appointed commissioners in the decision process:
These political considerations, delays, and implausible justifications for decision-making are not the only evidence of a lack of good faith and reasoned agency decision-making. Indeed, the record is clear that the FDA’s course of conduct regarding Plan B departed in significant ways from the agency’s normal procedures regarding similar applications to switch a drug product from prescription to non-prescription use, referred to as a “switch application” or an “over-the-counter switch.” For example, FDA upper management, including the Commissioner, wrested control over the decision-making on Plan B from staff that normally would issue the final decision on an over-the-counter switch application; the FDA’s denial of non-prescription access without age restriction went against the recommendation of a committee of experts it had empanelled to advise it on Plan B; and the Commissioner – at the behest of political actors – decided to deny non-prescription access to women 16 and younger before FDA scientific review staff had completed their reviews.
Medical products should be available to citizens because they are safe and efficacious, not to set social policy. I trust the NIH and the FDA on scientific matters. It’s important that science remains their focus.
By Michael W Simpson