FDA Commissioner Lester Crawford, D.V.M., Ph.D., effectively 'punted the ball' last month, putting off an FDA decision on whether to grant over-the-counter status for the emergency contraceptive known as Plan B in certain circumstances. Instead, Crawford announced he would open a public comment period on the OTC application to gain input on what he called "difficult and novel policy and regulatory issues."
Crawford announced the move Aug. 26 at a news conference in Washington, D.C. The announcement prompted an immediate outcry from, among others, Sens. Hillary Clinton, D-N.Y., and Patty Murray, D-Wash., who had earlier temporarily blocked a vote on Crawford's nomination to the top FDA post because of the Plan B issue.
In an Aug. 30 letter to HHS Secretary Michael Leavitt, Sens. Murray and Clinton voiced their dismay at Crawford's action, calling it "disappointing and frustrating" that HHS and FDA actions had hindered senators' job of protecting the "safety and well-being of the American public." The two senators have since petitioned Sen. Mike Enzi, R-Wyo., chair of the Senate Committee on Health, Education, Labor and Pensions, for a hearing on the delay. Most recently, they joined with 11 Senate colleagues in calling for the Government Accountability Office to release the findings of its ongoing investigation examining FDA's rejection of the Plan B application.
Crawford's action also has raised the ire of a number of health policy and consumer advocates, who view the Plan B application as an access issue and charge the agency with placing politics before science. Others, however, praised Crawford's move, including one former member of FDA's Advisory Committee for Reproductive Health Drugs, who said FDA was correct in taking more time to examine the legal implications of approving the application, submitted by Barr Laboratories, maker of Plan B.
The FDA's own Center for Drug Evaluation and Research has said sufficient data exist to support safe use of the progesterone-only contraceptive on an OTC basis in women 17 and older, Crawford said at the news conference. However, Barr's application requests OTC status for Plan B for women 16 and older.
"The issues that we were asked to resolve, and the proposal that was put forth by Barr Labs, presented us with many difficult and novel policy and regulatory issues," Crawford said. "What we are saying today is that the agency is unable at this time to reach a decision on the 'approvability' of the application because of these unresolved regulatory and policy issues that relate to the application we were asked to approve."
A key issue to be explored, according to Crawford, is whether age can and should be used as a criterion for determining a drug's availability on an OTC versus a prescription basis. Crawford questioned how the agency would be able to prevent girls younger than 16 from obtaining the drug over the counter. Also in question is the feasibility of marketing the same drug as both a prescription and an OTC product using the same packaging.
The FDA's "decision not to decide" also has had repercussions within the agency, with one top official resigning as a result of the delay. Susan Wood, Ph.D., signaled her protest Aug. 31 by resigning her post as director of the agency's Office of Women's Health.
"The science is not driving decisions," Wood said in a report on National Public Radio's Morning Edition Sept. 1 about the Plan B application for OTC status. "The mission of the agency is not being fulfilled in the way it should be.
"This delay, which would last several years, in fact, is denying appropriate access to this product, which is clearly safe and effective for this use."
Many of the issues Crawford said the FDA has yet to tackle are the same ones that spurred spirited discussion when, in 2003, the AAFP Congress of Delegates considered resolutions asking the Academy to support OTC status for progesterone-only contraceptives such as Plan B.
Members testifying in a reference committee hearing at that time expressed concern that making the drug available without a prescription could damage the patient-physician relationship, potentially putting women's health at risk.
In the end, however, AAFP delegates voted to support offering the drug as an OTC product for emergency contraceptive use, citing the lack of access to routine medical care experienced by many women, especially young women.
"Young people are disproportionately represented among the uninsured, and not many entry-level jobs come with health insurance," delegate Rachel Wheeler, M.D., of Concord, Mass., said at the hearing.
Further driving home the point was (then) Pennsylvania AFP President Wanda Filer, M.D., of York, who pointed to a poll in her state showing that 23 percent of sexual assault victims weren't offered emergency contraception in the state's emergency rooms. All the more reason to support an OTC progesterone-only contraceptive, she suggested.
Submit comments on the application online until Nov. 1.
