Non-Prescription Plan B Challenged in Lawsuit

Conservative groups have filed a federal suit against the Food and Drug Administration (FDA) in an attempt to overturn approval of Plan B, the “morning-after pill,” for non-prescription sale to women 18 and older. The plaintiffs, who include Concerned Women for America and the Family Research Council, say that the FDA approved non-prescription Plan B under “unlawful political pressure” from Senators Hillary Clinton (D-NY) and Patty Murray (D-WA).

Plan B, a brand of emergency contraception that prevents pregnancy when taken within 120 hours of unprotected sex, was approved for non-prescription sale after Clinton and Murray in August 2006 placed a hold on the nomination of a new FDA head pending a Plan B decision. The senators did not specify a particular outcome, only urging that the FDA issue a decision on the drug. They acted after the FDA had postponed making a decision on non-prescription Plan B for over three years (such decisions usually take less than a year) despite the fact that two FDA expert advisory panels early on voted 27-1 that Plan B was safe for all ages and 23-4 in favor of non-prescription use, and despite the drug’s overwhelming endorsement from national medical groups.

Many have blamed the FDA’s years of delay on the Bush administration’s political interference. Dr. Susan Wood, who resigned from her post as director of the FDA’s Office of Women’s Health over the Plan B delay, said in a 2005 interview, “The agency was not acting independently. The leadership of the FDA overruled every level of staff review in the agency.” The agency’s head is appointed by the president.

The suit additionally charges that the FDA did not have the authority to create a new class of drug that does not require a prescription for women over 18, must be dispensed by a pharmacist, and requires a dual label for the over- and under-18 markets. These age and label restrictions were imposed by Bush-appointed FDA acting commissioner Andrew C. von Eschenbach and were met with frustration by reproductive-rights groups.

The lawsuit also erroneously claims that over-the-counter Plan B “causes an increase in the incidence of sexually transmitted diseases” and calls it “a dangerous drug.”

“It’s ridiculous to label as a ‘dangerous drug’ something that has been proven safer than aspirin, and it’s ridiculous to withhold this medical breakthrough from women,” says Eleanor Smeal, president of the Feminist Majority Foundation. “The irony is that some of the very people now claiming political interference are those who — for more than three years — used politics to trump good medical science.”


Civil Action Lawsuit No. 07: 0668-RCL 4/12/07; Family Research Council 4/13/07; NPR.org 8/28/06; NYT 8/24/06; Nerve.com 10/16/05; FMF; Guttmacher Institute; Washington Times 4/13/07

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