Friday, April 13, 2007

The Family Research Council and other groups yesterday sued the U.S. Food and Drug Administration, seeking to overturn the 2006 decision that allowed over-the-counter distribution of the contraceptive Plan B also called the “morning-after pill.”

Among its many complaints, the lawsuit — filed in U.S. District Court — accuses the FDA of violating the law by allowing the same drug to be distributed simultaneously by prescription and over the counter, and charges that the FDA’s decision was made under improper political pressure from Democratic Sens. Hillary Rodham Clinton of New York and Patty Murray of Washington state.

“We don’t think moving this to over-the-counter is like moving a cold medicine,” said Chris Gacek, an attorney for FRC, a Washington-based conservative organization. “There are a lot of concerns.”

“It’s really simple — it just needs to be overturned,” said Charmaine Yoest, FRC’s vice president for communications.

An FDA spokesperson said in an e-mail that the FDA does not comment on pending litigation. Calls to the offices of Mrs. Murray and Mrs. Clinton were not immediately returned.

FRC along with Concerned Women for America, Safe Drugs for Women and the Association of American Physicians and Surgeons are suing the FDA and FDA Commissioner Andrew Von Eschenbach over the August decision to allow nonprescription sales of the morning-after pill to those 18 or older, but retain it as a prescription-only product for those 17 or younger.

Their lawsuit charges that the FDA had no authority to approve the same drug and labeling for simultaneous prescription-only and over-the-counter distribution and that the FDA cannot treat the drug differently based on the age of the buyer because “FDA lacks the authority to enforce Plan B’s age limitations.”

The FDA also failed to take some of the steps required during the decision-making process, produced a misleading label and failed to prove the drug is safe for use by teenagers, who could still get it over the counter if it’s purchased by an older person, the lawsuit says.

“This lawsuit argues that the FDA committed numerous violations to approve this drug,” said Wendy Wright, president of CWA.

Notably, it also argues the FDA’s decision was politically influenced because Mrs. Clinton and Mrs. Murray both placed “holds” on Dr. Von Eschenbach’s nomination to lead the FDA until the Plan B decision was made. After the decision was made, they lifted their holds and Dr. Von Eschenbach was confirmed by the Senate in the ensuing months.

“It’s very clearly caught up in political dynamics and I would go so far as to say there is electoral politics involved here,” said Mrs. Yoest.

But Susan F. Wood — a research professor at the George Washington University School of Public Health who resigned her post as the FDA’s assistant commissioner for women’s health in 2005 when the agency refused to allow nonprescription sales of Plan B — said the senators simply urged the FDA to make a decision one way or the other and “didn’t say what the decision should be.”

The Plan B drug has been available by prescription since 1999, but there was a lengthy fight over whether to make it available over the counter. Some pro-life groups say the drug essentially produces an abortion since it prevents implantation of the embryo after conception. Critics also note that Plan B is essentially a higher dose of the main ingredient of the traditional birth control pill, which is still only available via prescription.

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