The Burrill Report


Health and Human Services Secretary Kathleen Sebelius has ordered the U.S. Food and Drug Administration to disregard its scientific findings and reject Teva Pharamceuticals’ controversial Plan B emergency contraceptive for over-the-counter sale to adolescents. Though the secretary has the legal authority to override the FDA, it is believed to be the first time that one has actual done so.

“Today’s action reflects my conclusion that the data provided as part of the actual use study and the label comprehension study are not sufficient to support making Plan B One-Step available to all girls 16 and younger, without talking to a health care professional,” Sebelius said. President Obama at a press conference said he was not involved in the process, but expressed support for Sebelius’ decision.

Plan B One-Step was originally approved in July 2009 for use without a prescription for females age 17 and older and as a prescription-only option for females younger than age 17. In February 2011, Teva Women’s Health submitted a supplemental application seeking to remove the prescription-only status for females younger than age 17 and to make Plan B One-Step nonprescription for all females of child-bearing potential.

In a statement issued by FDA Commissioner Margaret Hamburg explaining that the agency was denying approval at the instruction of Sebelius, she said that the FDA’s Center for Drug Evaluation and Research completed its review of the application and determined that the product was safe and effective in adolescent females, that adolescent females understood the product was not for routine use, and that the product would not protect them against sexually transmitted diseases. Additionally, she said, the data supported a finding that adolescent females could use Plan B One-Step properly without the intervention of a healthcare provider.

“I agree with CDER that there is adequate and reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential,” says Hamburg.

Though Plan B has long been steeped in controversy, the decision surprised many people. Some criticized the administration, which has prided itself on basing decisions on science over politics, for kowtowing to conservatives in an election year. Others warned that it created a dangerous precedent that could have lasting effects.

“When the FDA gets politicized the public health loses. This is a precedent whose reverberations will be felt for years and not in a good way. It needs to be reversed,” says Peter Pitts, president of the Center for Medicine in the Public Interest and a former FDA associate commissioner. “It’s a horrible, outrageous, ill-thought decision for a hundred different reasons.”


December 09, 2011
http://www.burrillreport.com/article-sebelius_blocks_otc_sales_of_morning_after_pill_to_adolescents_.html