U.S. District Court Dismisses Lawsuit Against FDA Over Nonprescription Sales Of Plan B

Main Category: Women's Health / Gynecology
Also Included In: Sexual Health / STDs;  Medical Malpractice / Litigation
Article Date: 07 Mar 2008 - 5:00 PDT

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The U.S. District Court for the District of Columbia on Tuesday dismissed a lawsuit that sought to overturn an FDA decision allowing nonprescription sales of the emergency contraception Plan B to women older than age 18, Reuters reports. The court in its ruling said the plaintiffs failed "to identify a single individual who has been harmed by Plan B's [over-the-counter] availability" (Dixon, Reuters, 3/4).

The Family Research Council -- along with the Association of American Physicians and Surgeons, Concerned Women for America and Safe Drugs for Women -- filed the suit in April 2007. The suit alleged that FDA had no authority to approve the same drug and labeling for simultaneous nonprescription sales and prescription-only distribution. The lawsuit also claimed that the agency could not treat the drug differently based on the age of the buyer because "FDA lacks the authority to enforce Plan B's age limitations." It also alleged that the decision to approve Barr Laboratories' application was made under "improper political pressure" from Sens. Patty Murray (D-Wash.) and Hillary Rodham Clinton (D-N.Y.) (Daily Women's Health Policy Report, 4/13/07).

The court ruled that the groups filing suit did not have standing to sue, adding that the "plaintiffs have failed to exhaust their administrative remedies and have therefore failed to state a claim upon which relief can be granted." FDA spokesperson Rita Chapelle said the agency is pleased with the ruling. Carol Cox, a spokesperson for Barr, said the suit was "meritless."

The Center for Reproductive Rights has filed a separate suit against FDA that alleges the agency's decision to prohibit nonprescription sales of Plan B to girls younger than age 18 was based on politics rather than science, Reuters reports (Reuters, 3/4).

Oregon Health Department Files Rules To Enforce EC Law

In related news, the Oregon Department of Human Services on Monday filed administrative rules to implement a law (PL 435.254) that requires hospital staff to inform sexual assault survivors about EC and make it available upon request, the Oregonian reports. The department distributed fliers and posters informing doctors and patients about the rule, which went into effect Jan. 1. In addition, the department set up a system to address complaints about violations of the law.

Gary Young, medical director of the emergency department at Sacred Heart Medical Center in Eugene, Ore., said he was not aware of the law but added that it has been standard practice to offer EC to sexual assault survivors. He added that most survivors ask for EC after receiving information about the drug (Dworkin, Oregonian, 3/4).

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