New York District Court Rebukes FDA Over PLAN B OTC Switch Approval Decision; Vacates FDA Citizen Petition Decision and Remands to FDA

March 23, 2009

By Kurt R. Karst –      

In a scathing 52-page opinion issued earlier today, the United States District Court for the Eastern District of New York takes FDA to task over the Agency’s August 24, 2006 approval of a supplemental NDA (“sNDA”) for Barr Pharmaceuticals, Inc.’s emergency contraceptive PLAN B (levonorgestrel) Tablets, 0.75mg and denial of a citizen petition requesting FDA to switch PLAN B (and all emergency contraceptives like it) from prescription-only to OTC status without age or point-of-sale restrictions.  FDA’s August 24, 2006 approval permitted Over-the-Counter (“OTC”) use of PLAN B in women 18 years and older and maintained prescription status for women 17 years old and younger.  As we previously reported, another attempt to vacate FDA’s PLAN B approval failed when the United States District Court for the District of Columbia ruled in March 2008 that plaintiffs lacked standing to assert the claims in the complaint, and because the plaintiffs also failed to exhaust their administrative remedies.

Today’s decision is filled with intimate details of the FDA PLAN B decision-making process.  Here are the exact words of the court's decision:

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.

. . . [N]o useful purpose would be served by continuing to deprive 17 year olds access to Plan B without a prescription.  Indeed, the record shows that FDA officials and staff both agreed that 17 years olds can use Plan B safely without a prescription.  The FDA’s justification for this age restriction, that pharmacists would be unable to enforce the prescription requirement if the cutoff were age 17, rather than 18, lacks all credibility.

The court ultimately vacated FDA’s citizen petition denial and remanded the matter back to FDA for the Agency to “reconsider its decisions regarding the Plan B switch to OTC use.”  In addition, the court also ordered FDA to permit Barr, within 30 days, “to make Plan B available to 17 year olds without a prescription, under the same conditions as Plan B is now available to women over the age of 18. 

Categories: Drug Development