Did FDA Play Politics With Plan B?

Congressional investigators fueled the fire of a seething ideological debate on emergency contraception yesterday when they characterized the Bush administration's handling of the morning-after pill as "unusual."

Although the basic facts of the story, which began in 1999, have been known, the strongly worded Government Accountability Office (GAO) report will provide the Democrats who requested it with support for their charges that high-ranking administration officials interfered with the inner workings of the Food and Drug Administration (FDA).

The GAO does not draw such a conclusion but leaves unanswered the question of why the FDA acted as it did. The GAO did not question White House or Health and Human Services officials. At the center of the storm is the FDA's decision in May 2004 not to approve Barr Laboratories' request that its drug, known as Plan B, be granted over-the-counter status. The company submitted new information in July 2004 but a final ruling has not been issued.

The report states that high-level FDA officials took special interest in Plan B and that the agency departed considerably from its regular procedures. The FDA defended its actions in comments signed by FDA Deputy Commissioner for Operations Janet Woodcock. The report is not definitive about the motives of the FDA leadership, however. One reason for the lack of certainty on this point appears to be that the GAO was unable to interview two former FDA commissioners, Mark McClellan and Lester Crawford.

McClellan ran the FDA from November 2002 to March 2004. "We were unable to arrange an interview, and he did not respond to written questions we submitted," the GAO notes. McClellan responded in writing that the agency's decision on Plan B was made after he left, according to the GAO.

However, the GAO investigation shows that McClellan was aware of and involved in Plan B issues during the months leading up to his departure.

McClellan left the FDA to take the helm at the Centers for Medicare and Medicaid Services, which he still heads. Former FDA Commissioner Lester Crawford responded to the GAO only through his attorney. Crawford was deputy commissioner under McClellan and served as acting commissioner until being confirmed by the Senate this July; he left the FDA in September.

"We were unable to arrange an interview with him or obtain a response to our written questions prior to his departure from FDA," the GAO report says. Crawford denied any direct involvement in the Plan B decision-making process.

Plan B nearly scuttled Crawford's confirmation and may have contributed to his quick departure. Just one month before quitting, Crawford announced an additional delay of a final decision on Plan B. The move broke a promise made by Health and Human Services Secretary Mike Leavitt that the FDA would take action by Sept. 1. The GAO did not evaluate the FDA's actions after May 2004. FDA employees interviewed by the GAO believed their leaders were deeply involved in the consideration of Plan B's application, according to the report.

"FDA review staff told us that they were told early in the review process that the decision would be made by high-level management," the GAO reports. The GAO also says it received conflicting accounts of exactly when the FDA leadership decided to reject Barr's application. Some employees said the decision had been made before agency scientists finished reviewing the application. In a break with normal procedure, the acting director of the FDA's Center for Drug Evaluation and Research, Stephen Galson, notified Barr. Under standard practice, the staff members who conducted the review would have sent a letter to Barr that its Plan B application was not "approvable." In this case, they did not even co-sign Galson's letter because they disagreed with the agency's decision.

The FDA also disregarded the nonbinding recommendation of a joint advisory committee that Plan B could be appropriately used without a prescription. Among the 23 drugs that received an advisory-committee ruling in favor of over-the-counter sales since 1994, Plan B is the only one the FDA rejected.

The GAO also found that the criteria used by Galson to turn down Barr's application were out of the ordinary as well.

Galson told Barr that the FDA did not have enough information about how teenagers below age 16 would use Plan B. The GAO notes, however, "there are no age-related marketing restrictions for any prescription or [over-the-counter] contraceptives that FDA has approved, and FDA has not required pediatric studies for them."

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