Drug maker resubmits bid to sell 'morning-after' pill

Articles: Drug maker resubmits bid to sell 'morning-after' pill

Posted by admin on Friday, July 23, 2004 - 01:09 AM

Barr Pharmaceuticals Inc. resubmitted its bid for approval to sell a ''morning-after" contraceptive without a prescription, the company said yesterday.
The new proposal would allow girls and women age 16 and older to buy the drug over the counter, but girls 15 and younger would still need a prescription, Barr said. The Food and Drug Administration in May rejected an earlier request from Barr to sell the emergency contraceptive, called Plan B, sparking controversy over whether the decision was based on scientific evidence or political pressure. Despite a 23-4 vote from an FDA advisory panel of outside experts in favor of the over-the-counter plan, a top scientist at the agency, Dr. Steven Galson, said there was not enough evidence that girls ages 11 to 14 could use the drug safely. Yesterday, Barr said it believed its new proposal ''will lead to approval." The FDA must respond to Barr's new application within six months, the company said. An FDA spokeswoman said the agency had no comment. The agency has faced political pressure over the pill, which reduces the chance of pregnancy if taken within 72 hours of unprotected sex. Supporters have said easier access to Plan B would reduce the number of abortions; conservative lawmakers and other opponents say it would lead to more promiscuity and sexually transmitted diseases.

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