WASHINGTON — Overruling the recommendation of independent scientific experts, the Food and Drug Administration on Thursday rejected an application to make a "morning-after" birth control pill available without a prescription.
In a letter to Barr Laboratories, manufacturer of the emergency contraceptive Plan B, the agency said the company had failed to prove that girls younger than 16 could safely use the drug, now available by prescription, without the guidance of a doctor or other healthcare professional.
Some socially conservative groups praised the decision as a victory against promiscuity and unsafe sex. But some women's rights groups and scientific experts, who contended that making the drug more accessible would dramatically reduce the demand for abortion, said they believe that the decision reflected the value the Bush administration had put on politics over science.
In rejecting Barr's application to sell Plan B over the counter, the FDA laid out for the company what it needs to do to have another chance at winning approval, which the company said it would pursue.
Based on the FDA's letter, the company must submit results from a new study "demonstrating that Plan B can be used safely by women under 16 years of age without the professional supervision of a practitioner licensed by law to administer the drug."
Although Barr's original study enrolled 585 women, "only 29 ... were 14-16 years of age, and none was under 14 years of age," the agency said.
Alternatively, the FDA told the company, it could submit new information seeking to make Plan B available over the counter to women 16 and older but requiring girls younger than 16 to have a prescription for the drug.
"Wide availability of safe and effective contraceptives is important to public health," the FDA said in its letter. "We look forward to continuing to work with you if you decide to pursue either of these options."
Supporters of making emergency contraception more widely available said the approach by the FDA masked a highly unusual and politicized process. They said it was extremely unusual for the agency to overrule not only its outside advisors but also its staff.
They also questioned the timing of the decision, originally due in February. Because of the time it will take to submit a revised application, it would be at least six months and more likely a year -- after this fall's elections -- before Plan B could be made available without a prescription to at least some women.
