Monday, March 30, 2009

Good News For Reproductive Rights

U.S. District Court for the Eastern District of New York rejected the Bush administrations policy of allowing Plan B to be only over-the-counter. Judge Edward R. Korman found the FDA went against medical opinion to form policy.

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.

Plaintiffs are right. The FDA repeatedly and unreasonably delayed issuing a decision on Plan B for suspect reasons and, on two occasions, only took action on Plan B to facilitate confirmation of Acting FDA Commissioners, whose confirmation hearings had been held up due to these repeated delays. The first occasion involved the confirmation of then-Acting FDA Commissioner Lester M. Crawford, who froze the review process for seven months in 2005. In order to overcome a hold that had been placed on his nomination by two Senators, the Secretary of Health and Human Services promised that the FDA would act on Plan B by September 2005. After Dr. Crawford was confirmed by the Senate in July 2005, however, he reneged on the promise and, instead, delayed action another eleven months to pursue, and then abandon, a rulemaking with respect to Plan B. There is also evidence that when the FDA finally decided to approve non-prescription use of Plan B for women 18 and older, it did so to facilitate the confirmation of Commissioner Crawford’s successor, then-Acting FDA Commissioner Andrew C. von Eschenbach, whose confirmation certain Senators had vowed to block because of the continued delays on Plan B.

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.

The one thead that runs through every Bush cabinet department is putting politics over sound policy. The Obama administration is taking the first step to rescend a Department of Health and Human Services policy that would allow health care providers not to perform abortion. Bush used religious freedom as a cover. The Catholic church was successful in having the Nicaraguan government make abortion illegal. The result has been dead women. The sanctity of life apparently doesn't cover pregnant women.

The HHS rule ‘‘Ensuring that Department of Health and Human Services Funds Do Not Support Coercive or Discriminatory Policies or Practices in Violation of Federal Law’’ can cut off funding to any health care facility that forces a doctor or nurse to perform an abortion or sterilization. I have not read one news story of a health care worker forced to perform these medical procedures. I do remember a Hillsborough County jail preventing a rape victim from taking a second doze of Plan B. The victim reported being raped and the Tampa Police Department arrested her for owing $4,585 restitution. At least the jail worker was able to practice her religious freedom.

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At April 01, 2009 2:22 PM , Anonymous Anonymous said...

Chalk one up for policy based on science versus ideology! The US District Court's decision is an important victory for all Americans who expect the government to safeguard their health, not undermine it. With this ruling we have succeeded in expanding access to 17-year-olds without a prescription and are one step closer to making it fully available to all women.

But, emergency contraception is still difficult to access for many groups of women, including the more than 200,000 women serving in the Armed Services. It’s excluded from the list of what military facilities, including the primary stores where families shop, are required to stock. That can be particularly challenging for women and families who are based overseas and rely solely on those facilities to buy over-the-counter drugs. More than 160,500 American female soldiers have served in Iraq, Afghanistan, and the Middle East since the war began in 2003. According to a 2007 Department of Defense Report, there were 2,688 reported sexual assaults involving military personnel in 2007. Why would the government limit these women’s ability to prevent unintended pregnancies?

In the last Congress, then-Senator Hillary Clinton (D-N.Y.) and Rep. Michael Michaud (D-Maine), introduced legislation that would have required full access to emergency contraception for servicewomen at all U.S. military health care facilities around the world. We no longer, however, need to wait for Congressional action to right this wrong. President Obama has promised to restore scientific integrity to government actions in his administration.

Join me in calling on President Obama to direct Robert Gates, the Secretary of Defense, to make Plan B available to our servicewomen. Click here to send President Obama a message.

At April 01, 2009 2:23 PM , Anonymous Anonymous said...

Corrected link to send President Obama a message:


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