The agency’s scientific advisers had voted 23-4 in favor of over-the-counter access to emergency contraception as a safe way to prevent thousands of abortions. Historically the FDA has usually followed its advisers’ recommendations.
Despite the decision, FDA acting drug chief Dr. Steven Galson told reporters Friday that “we’re not shutting the door on (over-the-counter availability).” Galson overruled his own staff when he rejected Barr Laboratories’ application to sell Plan B, their emergency contraception, over the counter.
The FDA complained that Barr provided no data on use by girls under 16. Warned in February of that concern, Barr offered to require prescriptions from girls under 16. In Barr’s proposal, pharmacists would check IDs and make the drug available without a prescription to those 16 and older.
In its decision, FDA said the company didn’t provide necessary details on how such a program, never before tried in the United States, would work. It urged Barr to either provide more information to determine if the program would be legal and feasible, or provide data showing young women could safely handle easier access to the drug.
“Wide availability of safe and effective contraceptives is important to public health. We look forward to continuing to work with you if you decide to pursue either of these options,” the FDA letter said.
Barr “will pursue one or both of these” options, company spokeswoman Carol Cox told Reuters.
Barr Chairman and Chief Executive Officer Bruce Downey, in an interview with The News York Times, noted that cigarettes are freely sold to adults but that it is illegal to sell them to minors.
“There is more than one way to solve that logistical problem,” he told the paper.
Plan B is an emergency contraceptive that can cut a woman’s chances of pregnancy by up to 89 percent when taken within 72 hours of unprotected sex.
Conservatives welcomed the agency’s decision.
“The FDA is siding with our nation’s teens and their health,” Rep. Dave Weldon, R-Fla., himself a doctor, told the Associated Press.
“The FDA is right to be cautious about having a potent drug that can harm women next to candy bars and toothpaste,” said Wendy Wright of Concerned Women for America, a group that opposes abortion.
Advocates of wider access say it could help women get the pills early enough for them to be effective.
Dr. Alastair Wood of Vanderbilt University, one of FDA’s scientific advisers who voted to approve over-the-counter sales, told the AP Thursday’s decision will “have a negative impact on the public health.”
The FDA’s Plan B decision is “a shocking, unprecedented triumph of politics over science,” said Kirsten Moore, president of the Reproductive Health Technologies Project.
By going against the advisory panel’s advice, “the White House is putting its own political interests ahead of sound medical policies that have broad support,” said Phil Singer, a spokesman for Massachusetts Sen. John Kerry, the likely Democratic challenger to President Bush in the November election.
White House spokesman Jim Morrell maintained FDA scientists made the ruling.
“This was a decision made by career scientists at the FDA whose primary responsibility is to ensure that the public health is protected,” Morrell said.
Galson Friday repeatedly denied that politics played a role in his decision and said he had no contact with White House officials and considered only scientific questions.
Five states — California, Washington, Alaska, Hawaii and New Mexico — already allow women to buy morning-after pills from certain pharmacists without a prescription. The FDA’s decision does not affect those programs.