Oct. 14, 2005 – As national legislators await the final version of a government study on the much-disputed handling of emergency contraception rules under outgoing Food and Drug Administration Director Lester M. Crawford, a bipartisan group of lawmakers is seeking to resurrect the issue quickly. The Government Accountability Office is expected to make the report public by monthâ€™s end.
- FDA Delays Approval of Morning-After Pill, Considers Restrictions (Apr 10, 2004)
- FDA Stalls on Plan B Again (Aug 29, 2005)
- Womenâ€™s Health Chief Quits over Plan-B Procrastination (Sep 2, 2005)
The sale of emergency contraception in the United States has long been under dispute. An FDA decision over making non-prescription sales of pills that can safely prevent the implantation of fertilized cells was expected this year, but Crawford stalled the decision twice, the last time indefinitely.
Plan B is nearly universally recognized as a safe form of contraception. Government-approved research and medical experts have determined that the medication is safe for women as young as sixteen.
In letters sent this month to acting FDA head Andrew C. von Eschenbach, Senators and Representatives of both parties demanded an agency decision on the sale of Plan B, an emergency contraceptive sold by Barr Pharmaceuticals.
On October 7, the Congressional Pro-Choice Caucus sent a letter decrying Crawfordâ€™s August deferral of an FDA decision on the drug. The letter, co-signed by 62 members of Congress, urged von Eschenbach to approve Barrâ€™s application, commenting on early FDA action: "We believe this new delay does not truly reflect valid scientific or regulatory concerns."
Wednesday, New York Senator Hillary Clinton and Patty Murray jointly released a new letter calling for Plan B approval and announced a petition drive to force the FDAâ€™s hand on the issue.
According to the Washington Post, Crawford declined to cooperate with GAO investigators working on the forthcoming Plan B report. Congressional staffers familiar with the report said there are a number of footnotes mentioning the former FDA directorâ€™s refusal to be interviewed, the paper reports.
Criticism over the FDAâ€™s handling of the issue increased this summer when Crawford announced that he was deferring a decision on allowing over-the-counter sales of the so-called "morning-after" pill. The agencyâ€™s handling of the matter spurred the August departure of the FDAâ€™s chief womenâ€™s-health officer.
Earlier this month, an FDA advisor on over-the-counter drug sales resigned his position.
"There wasn't any observable scientific or procedural reason for them to first decline and then further delay the decision," Dr. Frank Davidoff told the AP in an interview. "I had to make the inference this was a decision that was made on the basis of political pressure, and it seemed to me that was unacceptable."