WASHINGTON (Reuters) – Barr Pharmaceuticals Inc. won U.S. approval to sell its Plan B "morning-after" contraceptive without a prescription to women 18 and older, the company said on Thursday.
Younger girls still need a prescription for Plan B, Barr said in a statement. The Plan B pills may prevent pregnancy when taken within 72 hours of sexual intercourse.
The Food and Drug Administration approval follows more than three years of controversy. Backers and opponents of wider access had fiercely lobbied the agency, and the feud stalled the nominations of two FDA commissioners.
Plan B will be kept behind pharmacy counters, Barr said. The pills should be available in a dual nonprescription and prescription package by the end of the year.
"While we still feel that Plan B should be available to a broader age group without a prescription, we are pleased that the agency has determined that Plan B is safe and effective for use by those 18 years of age and older as an over-the-counter product," Barr Chief Executive Bruce Downey said in a statement.
Considering the President’s comments this week this is no surprise and seems to have been a done deal. Some commented that I shouldn’t jump the gun in my reaction in a previous post and they were probably right. Having your cynicism validated though is not something to cheer about. In a related story.
Federal regulators have not only cleared the way for over the counter sales of a morning after pill.
They’ve also eliminated the hurdle that threatened to sink President Bush’s pick to head the Food and Drug Administration.
Two senators who had blocked Andrew von Eschenbach’s nomination have withdrawn their objections since an FDA compromise was announced today.
The ruling lets women 18 and over buy the Plan B contraceptive without a prescription. Girls 17 and younger will have to have a doctor’s note.
Senators Hillary Rodham Clinton and Patty Murray say they still want the FDA to revisit the age restrictions. But their statement says the ruling is "real progress" toward giving all women access to emergency contraception.
Now since this is an FDA decision I don’t believe there is anything that can be done via either half of the house or the President. Of course since the President already knew the views of Acting Commissioner Andrew von Eschenbach he obviously approves of them when he put him forward to the Congress.
Republican Sen. George Allen was recently cited for having stock in Barr Laboratories Inc. the company that won permission for the OTC use of Plan B. He replied to this accusation by saying:
"I very much like them," Allen said after a campaign speech at a senior citizens home here. "It’s a good company. I don’t use their products, but it’s a good company that works hard in the community."