In April 2003 Barr Pharmaceuticals submitted an application to the Food and Drug Administration requesting that Plan B–an emergency contraceptive often referred to as the morning-after pill–be made available without a prescription and sold straight from the drugstore shelves, like condoms.
Twenty-seven months later, American women are no closer to having easy access to Plan B, which prevents an unplanned pregnancy if taken within seventy-two hours after unprotected intercourse. Currently facing sharp criticism from both the left and right over its bungling of the matter, the FDA today simply refuses to issue a decision on emergency contraception, although one was due this past January. Veteran observers pronounce the FDA “stuck in the mud” on Plan B.
The present standoff is a testament to the extraordinary influence of the Christian right over Bush Administration policy on women’s reproductive health.
Eight months after Barr submitted its initial application, an FDA advisory committee voted overwhelmingly (23 to 4) to go over-the-counter with emergency contraception. Scientists on the panel determined the drug to be both safe and effective, ruling that easy access to Plan B was critical to preventing unintended pregnancies, thereby reducing the need for abortion.
That should have been the end of it. But Bush Administration officials, concerned at the time with marshaling the evangelical vote in the presidential election, weren’t pleased with the committee’s decision. As The Nation first reported in May, an FDA staff member contacted Dr. W. David Hager–a controversial evangelical Ob-Gyn on the panel who voted against Plan B–and requested that Hager write a “minority opinion” to further elucidate objections he raised during the hearings; namely, that wider access to emergency contraception would increase “risky behavior” among girls as young as 11 or 12 [see McGarvey, “Dr. Hager’s Family Values,” May 30].
But the FDA had on hand six independent studies confirming that expanded access to Plan B in no way increased sexual activity among young teens (and subsequent studies have confirmed those results).
Despite an intense lobbying effort by physicians and women’s groups, in May 2004 top FDA officials bowed to election-year pressures and denied Barr’s application to make Plan B available over the counter. The rejection letter to the manufacturer echoed precisely Hager’s concerns about the safe use of the drug by girls under 16.
But Barr wasn’t ready to call it quits. In July 2004 the manufacturer submitted a second application, this time proposing a compromise: that Plan B be marketed as prescription-only to girls under 16, and as nonprescription to older users–effectively giving one product a “dual status.” Under this scheme, a woman looking for Plan B will enter a drugstore, approach the pharmacy counter and ask the pharmacist or technician if the store carries emergency contraception. If it does, she must show an ID to confirm that she is older than 16 in order to purchase the product. Girls under 16 are out of luck.
This proposed “behind-the-counter” arrangement raises several serious concerns. Never before has the FDA approved a drug for this type of distribution, and it is unclear whether the agency even has the statutory and regulatory authority to do so. Some industry experts worry that a new label will make large pharmacy chains nervous about stocking Plan B at all, given the possibility of a lawsuit over such a hot-button product. (Wal-Mart already refuses to carry Plan B in its pharmacies, citing its customers’ ethical concerns over the drug.) Women’s groups have called the new age requirement a “bogus” response to political pressure; advocates fear that women seeking anonymity will be deterred from purchasing the morning-after pill if it requires an interaction with a pharmacist.
The dual-status scheme doesn’t satisfy the hard right, either. Concerned Women for America, perhaps the morning-after pill’s most vocal opponent, has called on the FDA to reject Barr’s revised application, claiming (preposterously) that rapists and molesters will slip Plan B pills to young women to “hide” their crimes.
After the FDA missed the January deadline to respond to Barr’s second application, in February the Bush Administration nominated Lester Crawford to serve as the agency’s permanent commissioner. Senate Democrats Hillary Clinton and Patty Murray have placed a hold on Crawford’s nomination until the agency announces its decision on Plan B. To date, the FDA has issued no further information on the future of emergency contraception. Nor has a vote been scheduled to bring Crawford’s nomination to the Senate floor.
As for Dr. Hager: On May 11 The Nation published its story revealing his behind-the-scenes role in the Plan B decision, as well as his ex-wife’s allegations that Hager sexually and emotionally abused her throughout their thirty-two-year marriage. The next day Hager announced that he would step down from his FDA post. “I will no longer be on the advisory committee after June 30,” he said.
