Judge: FDA Overstepped Bounds in Restricting 'Plan B' Contraceptive
A federal regulatory agency overstepped its bounds in limiting access to the so-called “Plan B” emergency contraceptive, a federal judge has ruled.
In setting special requirements for the controversial contraceptive, the U.S. Food and Drug Administration “departed in significant ways from the agency’s normal procedures regarding similar applications to switch a drug from prescription to non-prescription use,” says U.S. District Judge Edward Korman in a 52-page written opinion today.
The FDA has been requiring teens less than 18 years old to get a prescription, in order to use the over-the-counter Barr Pharmaceutical Inc. medication. As a result, pharmacies must keep it behind the counter, effectively requiring women 18 and older to ask a pharmacist to purchase it.
In his order today, however, Korman tells the FDA to make Plan B available to women age 17 and older within 30 days and to reconsider whether to require a prescription for teens of any age who seek access to the drug, according to Reuters and the Washington Post.
The Center for Reproductive Rights sued the FDA in U.S. District Court in Manhattan in January 2005, and the FDA subsequently approved Plan B for over-the-counter use in 2006. However, the center continued on with the lawsuit, challenging the manner in which the FDA handled the matter, reports the Wall Street Journal (sub. req.).
“Today’s ruling is a tremendous victory for all Americans who expect the government to safeguard their health not undermine it,” says the center’s president, Nancy Northup, in a statement e-mailed to Bloomberg. “The court recognized that the FDA favored politics over science, ideology over women’s health, and violated the law in the process.”
The FDA apparently has not yet commented on the decision.
Related coverage:
PR Newswire: “FDA Grants OTC Status To Barr Pharmaceuticals, Inc.”
