Barr Pharma Down on FDA Ruling {But not by much <AJM>]
By Robert Steyer
TheStreet.com Staff Reporter
5/7/2004 10:32 AM EDT
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Updated from 9:21 a.m. EDT
Barr Pharmaceuticals(BRL:NYSE - commentary - research) shares fell Friday after the Food and Drug Administration late Thursday rejected the company's permit for a prescription contraceptive to be sold over-the-counter, in an unusual move where the agency went against the recommendation of its advisory panel.
The agency issued a "not approvable" letter to Barr concerning Plan B, the so-called "morning after" pill. Plan B has been sold by prescription as an emergency contraceptive that, if taken within 72 hours of unprotected sex, can reduce the risk of pregnancy by 89%. Plan B is 95% effective when taken in the first 24 hours after intercourse.
The agency said Barr failed to provide "adequate data to support a conclusion that Plan B can be used safely by young adolescent women for emergency contraception without the professional supervision of a [licensed] practitioner," according to portions of the FDA letter released by Barr.
Barr's stock fell 80 cents, or 1.8%, to $43.
According to the letter, the FDA gave Barr two choices: provide additional data "demonstrating that Plan B can be used safely by women under 16 years of age without professional supervision" or supply additional information that would convince the FDA that Plan B could be sold over-the-counter to women 16 years and older and sold by prescription to women under 16.
The FDA's ruling will have a greater impact on political debate than on Barr's bottom line.
Many analysts have said that a nonprescription form of Plan B could produce annual revenue of $25 million to $35 million; the highest estimate has been $100 million a year.
That's more than the estimated $10 million in Plan B revenue recorded by the privately held Women's Capital Corp., which Barr acquired in February. Barr also has acquired the assets and technology of another private company, Gynetics, which sold Preven, the only other emergency contraceptive approved by the FDA. Barr had been manufacturing Preven for Gynetics. Preven is unaffected by Barr's efforts to convert Plan B into an over-the-counter drug.
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