U.S. regulators blocked unrestricted access to generic copies of an emergency contraceptive, affirming a move last week requiring girls under age 17 to have a prescription for the brand-name drug.
Health and Human Services Secretary Kathleen Sebelius ordered the Food and Drug Administration Dec. 7 to reject Teva Pharmaceutical Industries Inc. (TEVA)’s request to sell its Plan B One- Step as the first over-the-counter emergency contraceptive to women of all ages. Sebelius’s intervention was the first time HHS overrode an FDA staff decision. FDA Commissioner Margaret Hamburg said the agency would have approved the request.
The FDA maintained the policy for generic versions from manufacturers such as Watson Pharmaceuticals Inc. (WPI) of Parsippany, New Jersey and Perrigo Co. of Allegan, Michigan. The decision, released in a letter dated Dec. 12, was in response to a 2001 petition by the Center for Reproductive Rights in New York.
“We conclude that FDA needs additional data to support a switch of Plan B for women under 17 years of age,” the agency wrote in yesterday’s latter. “In the absence of such data, FDA declines to initiate a rulemaking to switch Plan B” to an over- the-counter product for those consumers.
The regulator cited lack of label-comprehension data for the two-dose Plan B in its decision. The petition is the subject of a 2005 lawsuit.
The emergency contraceptives reduce pregnancy risk if taken within three days of sex. They are sold behind pharmacy counters without a prescription to women at least 17 years old. Younger girls must obtain a doctor’s approval for the pill.
The center is set to argue in federal court Dec. 13 that the agency is in contempt for not deciding a 2001 request that is the basis of the lawsuit.
Sebelius Draws Criticism
“We’ve had many, too many, unwed births in this country,” he said yesterday at a meeting on health-care jobs in New York. “It would be much better if these young girls didn’t get pregnant. I agree with Hamburg.”
The mayor is founder and majority owner of Bloomberg LP, the parent company of Bloomberg News.
Hamburg said Dec. 7 said she was ready to approve over-the- counter sales based on “well-supported” and “science-based evidence.” Sebelius cited potential sales of Petach Tikva, Israel-based Teva’s One-Step to girls younger than age 17 in justifying her decision.
The Center for Reproductive Rights case is Tummino v. Hamburg, 05-cv-366, U.S. District Court, Eastern District of New York (Brooklyn).
To contact the editor responsible for this story: Adriel Bettelheim at email@example.com.