Washington Internal documents made public Thursday have raised new questions about the federal government's continued refusal to allow over-the-counter sales of the emergency contraceptive known as "Plan B."
The documents, obtained by Rep. Henry Waxman, D-Calif., show that in February 2004, policymakers at the U.S. Food and Drug Administration found no problem in allowing the so-called morning-after pill to be sold without a prescription to women of all ages.
Yet 18 months later, former FDA Commissioner Lester Crawford cited concerns about selling the drug to younger teens as a major reason for blocking the move.
The move prompted outrage from women's rights groups and Democratic lawmakers, who claimed that the agency was blocking the measure for political reasons despite scientific evidence that showed nonprescription sales of the pill were safe.
One FDA official opposed to the decision resigned.
FDA spokeswoman Susan Bro said Thursday night that the agency was reviewing the matter and had no further comment.
Barr Laboratories, the maker of Plan B, originally sought to sell the drug over-the-counter to women of all ages. Only after meeting resistance from FDA officials and conservative organizations did the company opt to require prescriptions for women ages 16 and younger.
The FDA records indicate that the change was engineered by FDA senior officials who worked behind the scenes against the company while appearing to remain neutral.
After mid-level FDA officials made their recommendation to approve Plan B sales without prescriptions, their superiors told them that FDA Commissioner Mark McClellan and other senior managers at the agency "cannot support the non-prescription switch of Plan B," according to the agency's records.
By that time, the FDA already had begun urging Barr to seek over-the-counter sales for those 17 and older.
Barr eventually did so, but the request was tabled in August by Crawford, who claimed the move raised "difficult and novel policy and regulatory issues." The FDA hasn't yet decided the matter, and Plan B remains available by prescription only.
In a letter to acting FDA Commissioner Andrew von Eschenbach that was released Thursday, Waxman contends that the FDA "created a regulatory 'Catch 22' to justify the predetermined political decision to block over-the-counter sales of Plan B."
"In essence, the agency was well aware of the regulatory questions that would arise when it suggested age restrictions, but simply did not resolve them in a timely manner," Waxman wrote. Waxman's office wouldn't disclose the source of the documents.
An April 2004 e-mail message from Jane Axelrad, associate director for policy at the FDA's Center for Drug Evaluation and Research, said that allowing over-the-counter and prescription sales of Plan B in the same package would be "consistent with precedent" and comply with "applicable statutory and regulatory provisions."
But that same month, an unidentified FDA deputy division director wrote that McClellan and senior management in Axelrad's department "do not concur" and "cannot support" such a move. They, in turn, asked the FDA's Office of Chief Counsel for a final assessment on whether the drug could be sold both with and without prescription for different age groups.
But that assessment was never made public.
Waxman wants von Eschenbach to disclose by March 27 whether the FDA's legal analysis of Plan B was ever completed.