WASHINGTON, May 9 (UPI) -- Medicare chief Mark McClellan is set to testify June 13 in a lawsuit attempting to force over-the-counter sales of Plan B.
McClellan, administrator of the Centers for Medicare & Medicaid Services and former commissioner of the Food and Drug Administration, will be questioned as part of a lawsuit charging FDA wrongfully rejected an application submitted by Barr Laboratories to sell the emergency contraceptive without a prescription, Long Island Newsday reported Tuesday.
The FDA said the May 2004 application submitted by the manufacturer was not approvable because the company did not have data about the effects of the medication on women younger than 16.
The company then resubmitted its application in January 2005 to include only sales to women 17 and older, but the agency announced it would be delaying its decision.
The lawsuit was then filed by the Center for Reproductive Rights on behalf of the Association of Reproductive Health Professionals and other groups in a New York U.S. District Court, claiming the agency violated its own procedures when it first denied the application.
Plan B, also known as the morning after pill, can reduce the likelihood of pregnancy after unprotected or unwanted intercourse for several days, but is more effective the sooner it is taken.
