FDA faces Plan B law suit for OTC approval

The US Food and Drug Administration has found itself in the middle of a political tug of war between advocates and opponents of a "morning after" birth control drug produced by New Jersey-based Barr Pharmaceuticals. A law suit has been filed against the federal agency over its decision in August 2006 to authorize over-the-counter sales of the oral emergency contraceptive Plan B (levonorgestrel) to over 18 year olds.

The action is supported by a gathering of activist groups: the Family Research Council; the Association of American Physicians and Surgeons; the Concerned Women of America; and Safe Drugs for Women. They argue that the FDA "lacks the authority to enforce Plan B's age limitations" and was the result of "improper political pressure." The compromize by the agency came as two Democratic Party Senators had placed a "hold" on the permanent appointment of the then FDA Acting-Commissioner, Andrew von Eschenbach (Marketletters passim). That protest, by Sens Hillary Clinton (New York) and Patty Murray (Washington), was in turn based on the claim that delays in a decision on OTC sales of Plan B, were based on political considerations, rather than safety or efficacy.

With several Republicans having already launched campaigns for the presidential primaries early next year, the legal action by conservative pressure groups will likely be used to gauge the position of candidates in coming weeks. For its part, the FRC's vice president for external relations, Charmaine Yoest, claimed that the FDA's decision on Plan B was "very clearly caught up in political dynamics, and I would go so far as to say that there is electoral politics involved here," according to the Washington Times.