The battle over access to Plan B has dragged on for the better part of a decade, through the terms of three FDA commissioners. Among many in the medical community, it came to symbolize the decline of science at the agency because top FDA managers refused to go along with the recommendations of scientific staff and outside advisers that the drug be made available with no age restrictions.
“The FDA got caught up in a saga, it got caught up in a drama,” said Susan Wood, who served as the agency’s top women’s health official and resigned in 2005 over delays in issuing a decision. “This issue served as a clear example of the agency being taken off track, and it highlighted the problems FDA was facing in many other areas.”
The treatment consists of two pills and sells for $35 to $60. Women must ask for Plan B at the pharmacy counter and show identification with their date of birth. The drug is made by a subsidiary of Teva Pharmaceutical Industries, an Israeli company. It does not prevent sexually transmitted infections, such as HIV/AIDS.
Supporters of broader access argued that Plan B is safe and effective in preventing unwanted pregnancy and could help reduce the number of abortions.
Opponents, including prominent conservatives, counter that it would encourage promiscuity and might even become a tool for criminals running prostitution rings, as well as for sexual predators.
Early in the Bush administration, more than 60 organizations petitioned the FDA to allow sales without a prescription. But according to court documents, the issue quickly became politicized.
In 2003, a panel of outside advisers voted 23-4 to recommend over-the-counter sales without age restrictions. But top FDA officials told their subordinates that no approval could be issued at the time, and the decision would be made at a higher level. That’s considered highly unusual, since the FDA usually has the last word on drug decisions.
In his ruling, Korman said that FDA staffers were told the White House had been involved in the decision on Plan B. The government said in court papers that politics played no role.
In 2005, the Center for Reproductive Rights and other organizations sued in federal court to force an FDA decision.
The following year, the FDA allowed Plan B to be sold without a prescription to adults. But the controversy raged on over access for teens.