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Barr Pharma Down on FDA Ruling

The agency rejects its application to grant a contraceptive over-the-counter status.

Updated from 9:21 a.m. EDT

Barr Pharmaceuticals


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.

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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.

For the nine months ended March 31, Barr earned $108.7 million on sales of $1 billion. Barr specializes in contraceptives and women's health products as well as a wide variety of generic drugs.

A Measured Response

"While we are disappointed that FDA did not approve our application at this time, we are encouraged by FDA's suggestions, and look forward to working with the agency toward approval of Plan B for over-the-counter use," Bruce L. Downey, Barr's chairman and CEO, said Thursday. "In the meantime, we remain committed to providing Plan B as a prescription-only product and to increasing awareness among the health care provider community and women of this safe and effective option."

Downey didn't comment on strategy or a timetable for Barr's next move. His latest comments reflect the measured, low-key remarks made by Barr executives on the politically-sensitive product in recent months, following the FDA's decision to delay its review of Plan B. The agency was supposed to act by Feb. 20, but it said on Feb. 13 that it would extend its review and make a decision by May 21.

Supporters of Plan B being converted to nonprescription status have been less restrained in their comments. In early April, for example, the New England Journal of Medicine issued an editorial expressing concern that the FDA's deliberations were "being influenced by political considerations." The editorial feared that any FDA approval would be filled with restrictions "designed to intimidate women who require access to this medication."

The Planned Parenthood Federation of America said late Thursday that the FDA's decision was an example of politics trumping science. "There is no scientific reason to restrict access to this safe, effective backup method of contraception," said the organization's vice president for medical affairs, Dr. Vanessa Cullins, in a prepared statement. "Comprehensive scientific data show that Plan B meets the FDA's criteria for over-the-counter status."

In mid-December, two FDA advisory committees meeting jointly voted 23 to 4 in support of converting Plan B to over-the-counter status.

Plan B supporters say an OTC version of the drug would reduce the number of unwanted pregnancies because women could act quickly, without having to wait for a prescription. Other supporters include the American Medical Association and the American College of Obstetricians and Gynecologists.

Opponents of Plan B becoming a nonprescription product say easier access to the pill would increase promiscuity and sexually transmitted disease. Opponents include the U.S. Conference of Catholic Bishops, the Catholic Medical Association and antiabortion groups. Many opponents maintain that Plan B acts as an abortion agent, a claim vigorously rejected by Barr and its medical supporters.