Does the FDA Have a Plan B for Plan B?

J0302944 Recently, Acting FDA Commissioner Andrew C. von Eschenbach offered testimony before a House subcommittee. During Q&A, he was pressed on the matter of the continually pending RX to OTC switch of Plan B oral contraceptive, popularly known as the "morning after" pill because it acts by interfering with implantation. Because of this, it is regarded by some as a form of abortion.

Dr. von Eschenbach seemed to take the title "acting" to heart when he denied that politics played any role in the treatment of the Plan B application for a switch.

This is patently absurd.

In April 2003, the manufacturer of Plan B filed for the switch. In December 2003, 43 members of Congress which included Tom Delay sent a letter to FDA urging rejection of the application. Later that month, the advisory committee met and voted unanimously to approve the application. There were dozens of people who stepped forward to testify in the open public comment period. A member of Congress showed up. Then in May, 2004, the FDA issued an unapprovable letter to the sponsor of Plan B.

Reproductive rights have been one of the most divisive political issues of our time. A GAO report given to Congress has noted several irregularities in the way this application has been handled by the FDA.

The FDA has been suffering a historic lack of faith in its credibility as a result of a number of circumstances over the past two years. If anything, the agency should be doing everything within its power to re-establish that credibility. Instead, by allowing politics to trump science and issuing a non-approvable letter, the agency further eroded its own credibility. To maintain now that the process has not been political compounds the fracture.

The FDA needs a Plan B for handling this situation.

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