FDA okays Plan B for over-the-counter sale
WASHINGTON --The Food and Drug Administration today waived prescriptions for emergency contraception, a long-delayed move that allows women older than 18 to buy Plan B over the counter and removes the final barrier to confirmation of a permanent commissioner for the embattled agency.
Duramed, a subsidiary of Barr Pharmaceuticals, will specially label the product to indicate the age restriction and provide a tollfree number for an information line, the FDA said in a statement today.
But rather than silencing critics who had accused the FDA of politicizing the matter to appease conservatives, this morning's approval unleashed a new volley of accusations that the FDA was pandering to liberals. Two Democratic Senators, as expected, today lifted procedural holds that had blocked confirmation of the acting FDA commissioner until the agency decided the Plan B question.
Barr shares reacted in early morning trading, trading up 47 cents to $58.44 at just after 10 a.m.
Opponents say they will encourage consumers to avoid doing business with drug store chains that sell Plan B. Wendy Wright, head of the conservative group Concerned Women for America, said the group is stopping short of calling for an across-the-board boycott.
If consumers "have the slightest doubt over whether a drugstore chain or pharmacist is going to have their best interests -- or their child’s best interests -- at heart, then it’s just so easy to go to a different drug store," Wright said.
The FDA's decision simply waives that prescription requirement for women older than 18 and will not erode access to emergency contraception for younger women in Massachusetts, said Susan Winckler, staff counsel for the American Pharmacists Association.
Massachusetts legislators decided, over Governor Romney's veto, that women of all ages could get Plan B and allows pharmacists with special training to write the prescriptions. Some 13 pharmacies in the state currently sell Plan B without a doctor's prescription under the revised state law, according to the Planned Parenthood League of Massachusetts.
The CVS chain is developing a training program that will be voluntary for individual pharmacists who decide or decline to participate, said spokesman Michael DeAngelis. Some 300 CVS stores operate pharmacies in the state.
Wal-Mart Stores Inc. in March began carrying Plan B for purchase with a prescription. The policy reversal came weeks after the state pharmacy board ruled in favor of three women who filed complaints after Wal-Mart refused to fill their prescriptions. The chain, which operates 41 discount stores and three supercenters in Massachusetts, has not decided whether to sell the emergency contraceptive over the counter.
"It is something we would consider. But that’s all we have to say on that right now," said Kevin Gardner, a spokesman.
The contraception controversy began in April 2003, when Barr Pharmaceuticals Inc. sought to sell its emergency contraception to women of all ages without prescription. The so-called morning after pill, a high dose of oral contraceptive, blocks pregnancy when taken within 72 hours of unprotected sex.
When the FDA balked, Barr revised its application to sell Plan B to women 16 and older. Last year, the FDA upped the age restriction by one year, saying women 17 and older could safely take the drug without a doctor's oversight.
This summer, on the eve of a crucial Senate hearing, FDA acting commissioner Andrew von Eschenbach again shifted the age threshold upwards, to women 18 and older. This week, President Bush told reporters that he endorsed the new age criteria. Von Eschenbach had testified before the Senate that he -- not the White House -- drove the agency's changed stance.
