Judge: Bush White House Wanted Right-to-Lifers on FDA's Contraception Panel

A federal court ruling on Teva’s Plan B “morning after” contraceptive reveals how the Bush White House corrupted the internal operations of the FDA, encouraged decisions not based on science, and led to months-long delays in approvals process.

Judge Edward Korman’s ruling makes Plan B (pictured) available over-the-counter instead of behind-the-counter, ending a long and wasteful drama over Teva/Barr’s contraceptive.

The ruling describes in juicy detail how the Bush Administration twisted the FDA in knots in order to appease right-to-life constituents who were opposed to young women getting contraceptives. The office of the commissioner even proposed right-to-life campaigners be added to an advisory committee on Plan B.

The judge wrote that “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.”

Here’s a digest of the ruling:

Acting FDA Commissioner Lester M. Crawford … 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.

… 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.

… 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 record shows that FDA officials and staff both agreed that 17 year 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 Office of the Commissioner appointed members to the Advisory Committee not for their expertise, but to achieve what the Office of the Commissioner called a “balance of opinion” on the panel.

… Indeed, Dr. Kweder testified that the Commissioner’s office rejected many qualified nominees proposed by CDER in favor of individuals who shared a common ideological viewpoint. … Specifically, “the backgrounds of many of the candidates that were forwarded [by the Commissioner’s office] . . . had an ideological commonality. . . . They were . . . people who were very active in the Right to Life antiabortion world.”

“[t]he results of the AUS [actual use study] demonstrated that the frequency of unprotected sex did not increase, condom use did not decrease, and the overall use of effective contraception did not decrease [with use of Plan B].”

Dr. [Janet] Woodcock, Acting Deputy Commissioner, and Dr. Steven Galson, Acting Director for the Center for Drug Evaluation and Research (CDER), told their subordinates, Drs. Jenkins and Kweder, “that Plan B could not be approved on this round,”…

… they were told that the White House had been involved in the decision on Plan B. Dr. Kweder testified that Dr. Woodcock had told her at that meeting that:

Dr. McClellan had [not] made [the decision] on his own but … the White House was involved … we were told, and that it was made very clear that there were a lot of constituents who would be very unhappy with … an over-the-counter Plan B, and … [there] was part of the public that needed to have the message that we
were taking adolescents and reproductive issues seriously.

Acting Commissioner Crawford removed Dr. Galson’s authority to make a decision on the OTC switch application. This was the only time Dr. Galson had had his authority to make such a decision removed and the only time he is aware of it happening to any Center of Drug Evaluation and Research Director.

Acting Commissioner Crawford’s decision to remove Dr. Galson’s authority effectively froze the review process for more than seven months

When Dr. Wood met with Dr. Woodcock to discuss her resignation, Dr. Woodcock expressed concern that the FDA’s handling of Plan B could damage her own credibility. … On October 7, 2005, Dr. Frank Davidoff, a member of the FDA’s Nonprescription Drug Advisory Committee, also resigned because of the FDA’s delayed action on the Plan B switch application.

• See BNET’s previous coverage of Plan B:
  
• FDA’s “Hit List” List of Drugs With Potential Safety Concerns Features the Usual Suspects
• MTV Ad for Teva’s Plan B Morning-After Pill Has Some Parents Up in Arms
• Bush Administration Rule Stops Rape Victims Getting Plan B “Morning After” Pill