Court Finds Political Bias in FDA; Orders OTC Access and New Review of Plan B

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Teenage girls 16 and younger could soon have unrestricted access to a controversial over-the-counter contraceptive known as Plan B.

A federal judge in New York ruled last month that the Food and Drug Administration (FDA) had politicized the approval process for the so-called “morning-after” pill, and ordered the agency to reconsider its decision to require girls under age 18 to get a prescription in order to obtain the drug.

U.S. District Judge Edward R. Korman of New York found that the FDA delayed the approval process and ignored studies by career staff and independent researchers that found the pill caused only minor side effects, did not lead to promiscuity and was safe for women 17 and older. The court also found that the FDA had improper contact with White House officials and bowed to administration pressure not to approve the pill in order to appease constituents of President George W. Bush.

“These political considerations, delays, and implausible justifications for decision-making are not the only evidence of a lack of good faith and reasoned agency decision-making,” Korman wrote in his decision. “Indeed, the record is clear that the FDA’s course of conduct regarding Plan B departed in significant ways from the agency’s normal procedures regarding similar applications to switch a drug product from prescription to non-prescription use.”

The pill was ultimately approved for non-prescription use in August 2006, but only for women age 18 and older and only after years of delays and several reneged promises – made to speed up the confirmation process for top FDA officials – to issue a ruling soon.

The court ruling lists a series of peculiarities in the way the FDA handled the process on whether to allow girls under age 18 to obtain the pill without a prescription – a requirement the court said would render the pill useless since Plan B must be used within 72 hours, and it could take young women longer than that to obtain a prescription.

For instance, the court found that the people appointed by the FDA’s Office of the Commissioner to the FDA’s Advisory Committee for Nonprescription Drugs did not have any recognized expertise that would help the FDA in its deliberation process.

Instead, the court found, the people appointed to the committee had an “ideological commonality” and were “very active in the Right to Life anti-abortion world.”

The court ordered the FDA to approve immediately over-the-counter access for 17-year-old girls, since FDA reviews had already shown the pill did not cause significant health effects among that age population. The court also ordered the FDA to reconsider its prior decision to ban over-the-counter access for girls under age 17.