Plan B Decision Mobilizes House Members To Seek FDA Integrity Review
This article was originally published in The Tan Sheet
Executive Summary
A House bill directing FDA to conduct a formal review of the process leading up to its decision to designate as "not approvable" the Rx-to-OTC switch application for the Plan B emergency contraceptive was introduced by Rep. Carolyn Maloney (D-N.Y.) on May 14
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A House bill directing FDA to conduct a formal review of the process leading up to its decision to designate as "not approvable" the Rx-to-OTC switch application for the Plan B emergency contraceptive was introduced by Rep. Carolyn Maloney (D-N.Y.) on May 14. "Thirty days after the enactment of the legislation, the FDA Commissioner would be required to review its Plan B decision and affirm that it is not based on politics, that it is based on sound science and that it conformed to FDA precedent," according to Maloney. The "Science Over Politics Act" is intended to reopen the decision-making process and address widespread concerns that a political agenda influenced the regulatory review, lawmakers said. In a May 6 letter to Plan B sponsor Barr Labs, FDA cited a need for more data on use of the drug in adolescents under age 16 and requested details on the firm's proposed marketing plans (1 (Also see "Plan B OTC Submission Fails On Lack Of Data In Teens" - Pink Sheet, 10 May, 2004.), p. 5). "Evidence suggests that the FDA's decision resulted from an unprecedented political takeover of what is supposed to be an independent scientific review," the bill asserts. Moreover, the agency's "rejection of over-the-counter status for Plan B...directly contradicted the overwhelming weight of scientific evidence." "No one should object to this bill. If there was no political influence, what's wrong with passing this bill?" Maloney asked. "What's wrong with affirming that the decision was based on science, as it should be? What's wrong with having the FDA affirm that there was no political influence?" Reps. John Conyers (D-Mich.), Joseph Crowley (D-N.Y.), Lois Capps (D-Calif.) and Raul Grijalva (D-Ariz.) have joined Maloney in co-sponsoring the bill. The bill was announced at a May 12 Capitol Hill press conference, at which eight House members and more than 15 advocacy groups challenged the Plan B decision. Rep. Louise Slaughter (D-N.Y.) maintained the agency "can no longer be counted on to give scientific information to the citizens of the United States" and called upon FDA Acting Commissioner Lester Crawford, PhD, and Center for Drug Evaluation & Research Acting Director Steven Galson, MD, to resign their posts. The FDAers "need to step down at once," she said. "If this Administration cares at all about its own reputation in medicine, they will put somebody in there who has the guts to follow scientific principles." "They do not deserve to work for FDA," she added. Galson signed the "not approvable" letter sent to Barr Labs, an unusual step indicating the final decision was at odds with the recommendation of the reviewing staff. The decision also diverged from the recommendation of the agency's Nonprescription Drugs and Reproductive Health Drugs advisory committees, who voted 23-4 in favor of the switch (2 (Also see "Plan B Behind-The-Counter Status Discouraged By Panel Members" - Pink Sheet, 22 Dec, 2003.), p. 3). Slaughter said she has requested that the General Accounting Office conduct a study on FDA's decision. "We want [a] good study to be done by the GAO to tell us what exactly happened here. I want a chance to hear from the science. I want the people who were turned down," she said. Rep. Henry Waxman (D-Calif.) is authoring the letter asking GAO to look into the matter. Waxman also organized 48 House members in writing to then-FDA Commissioner Mark McClellan, MD/PhD, asking him to approve the drug before his departure to the Centers for Medicare & Medicaid Services (3 (Also see "Barr Adds Preven To OTC Contraceptive Pipeline" - Pink Sheet, 1 Mar, 2004.), p. 9). FDA's decision also has prompted a rebuttal by Rep. Christopher Shays (R-Conn.), who along with 41 other House members wrote to the agency May 7 asking that the decision be reconsidered. "We believe that in the FDA decision on the application for EC over-the-counter status, science and safety have taken a back seat to politics," the letter states. "This decision ignores the significant need for access to emergency contraception, including by young women," the letter continues, pointing to studies showing EC availability does not increase unprotected sex by teenagers, despite arguments to the contrary by EC opponents. The letter was signed by four Republicans, one Independent and 36 Democrats. |