GAO Draft Report Finds Plan B Rejection “Unusual”; Lawmakers Urge Decision
This article was originally published in The Tan Sheet
Executive Summary
The Government Accountability Office's investigation into FDA's initial denial of Plan B discovered that the agency's decision to issue a "not approvable" letter did not reflect the opinions of scientific review staff.
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The Government Accountability Office's investigation into FDA's initial denial of Plan B discovered that the agency's decision to issue a "not approvable" letter did not reflect the opinions of scientific review staff. GAO's draft report was made available Oct. 12 to members of Congress and FDA for comment. GAO will publish submitted comments in its final report. "The draft GAO report appears to confirm what we have suspected for some time: science was compromised in the FDA's decision making process on Plan B," Sen. Hillary Clinton (D-N.Y.) stated Oct. 13. GAO found the FDA's decision "unusual" in its involvement of high-level agency personnel, according to staff who had access to the report. The Washington Post reported the GAO investigation revealed the rejection of Plan B was discussed at an FDA staff meeting in January 2004 when Mark McClellan was commissioner, months prior to the announcement. The agency issued the "not approvable" letter to sponsor Barr Labs that May, citing concerns about the spread of sexually transmitted diseases among adolescents (1 (Also see "FDA Comes Under Fire From Sen. Clinton Over Plan B Decision" - Pink Sheet, 21 Jun, 2004.), p. 3). Clinton requested that GAO investigate the matter in June 2004. Barr submitted a second application in July of that year, seeking OTC status for the drug's use only by women aged sixteen and older. FDA issued a second letter to Barr on Aug. 26, 2005, indicating it could not reach a decision on the second Plan B switch application due to concerns about its use by adolescents and the legality of the dual marketing scheme. The agency announced an advance notice of proposed rulemaking to seek public comment on "unresolved regulatory and policy issues" related to the decision (2 (Also see "FDA “Unable” To Decide On Plan B, Seeks Comment On Dual-Status Drugs" - Pink Sheet, 29 Aug, 2005.), p. 4). Following the ANPR, Clinton was joined by 12 other senators to request that GAO expedite release of its findings (3 (Also see "FDAer Resigns Over Plan B; Senators Seek Results Of GAO Investigation" - Pink Sheet, 5 Sep, 2005.) p. 3). Separately, Clinton and Sen. Patty Murray (D-Wash.) sent a letter Oct. 12 to FDA Acting Commissioner Andrew von Eschenbach urging him to "expeditiously make a decision on the application for OTC status for Plan B based strictly on scientific evidence." The senators address FDA's focus on age concerns as "a major deviation from the FDA's normal standards" for evaluating reproductive health products. Previously, the agency's standards for reproductive health products "have treated all women of child-bearing age the same," therefore, FDA is "changing the rules midstream," by soliciting comment on the appropriateness of requiring an age distinction. The senators are urging citizens to endorse the letter by attaching their names to an electronic petition on Clinton's website, which will be then submitted to FDA before the Nov. 1 close of the comment period. Clinton and Murray cite a number of OTC products, namely nicotine replacement therapies, which are sold based on an age requirement. The two senators say they "are disturbed that this application has been subjected to scrutiny that far exceeds the normal FDA procedures." "It is virtually unprecedented for an over-the-counter application to be subjected to more than two years of inaction, only to be then subjected to an extended public comment period with no timetable for a decision." Members of the Congressional Pro-Choice Caucus also submitted comments "strongly urging" FDA to approve Plan B for over-the-counter sale in an Oct. 7 letter addressed to von Eschenbach and signed by 62 members of the House. "We are displeased that the FDA continues to delay, postpone and create impediments to issuing a decision on an application that its own expert advisory committee endorsed nearly 20 months ago." Rep. Louise Slaughter (D-N.Y.), who co-chairs the caucus, is among the signatories of the letter. Caucus members point to the May 2004 "not approvable" letter and maintain "the FDA stated that unless an age-based sales distinction was made, it would not approve" the application. "We find it contradictory and disconcerting that the FDA's concerns are a direct result of the agency's own recommendations last May," the letter states. - Melina Vissat |