Thought Theater

FDA To Consider Morning-After Pill OTC Sales genre: Hip-Gnosis & Little Red Ribbon-Hood & Polispeak

The Food and Drug Administration has announced that it is ready to consider over-the-counter sales of Barr Laboratories morning-after pill...a move that surprised many observers given the protracted delays that have raised concerns that the agency is allowing politics to guide medical decisions.

Despite the announcement, there is reason for skepticism since President Bush's nominee to head the Agency; Dr. Andrew von Eschenbach is scheduled to appear for confirmation hearings. Two Senators, including Hillary Clinton, have vowed to block the nomination until the agency makes a decision on over-the-counter sales. Read the full article here.

Barr’s application for over-the-counter approval of Plan B has been pending before the F.D.A. for three years and has sparked considerable discord within the agency. It has also become a proxy fight in the debate between foes and supporters of abortion rights.

In December 2003, an F.D.A. advisory committee voted 23 to 4 to approve Barr’s application with no age restrictions. Six months later, however, a top agency official rejected the application, citing concerns that the pill would be available to young teenagers.

Internal F.D.A. documents show that agency officials suggested to Barr that it rewrite its application to allow over-the-counter sales to adult women while still requiring younger teenagers to get a prescription. Barr did that, but in January 2005, the statutory deadline for an F.D.A. decision passed without a decision.

In a letter to Barr today, Dr. von Eschenbach indicated the F.D.A. would not approve Plan B for over-the-counter sale for girls under 18. “We believe that the appropriate age for OTC access is 18," he wrote.

While the F.D.A. has insisted that its decisions to reject or delay the Plan B application were the result of scientific or regulatory concerns, a Congressional investigation found last year that top agency officials decided at one point to reject the application before its staff’s scientific review was even complete.

Senator Clinton and Senator Murray issued a joint statement that accused the agency of making the announcement as a further effort to stall the approval of the pill. They indicated they would still block the nomination until such time as a decision was finalized.

Thought Theater previously reported on the controversy surrounding the agency and the approval of the pill for over-the-counter sales here.