FDA Adds New Hurdle to 'Morning-After' Pill

Agency officials deny move was politically motivated

FRIDAY, May 7, 2004 (HealthDayNews) -- The U.S. Food and Drug Administration has added a new hurdle before allowing a controversial emergency contraceptive to be sold on a nonprescription basis, but denied allegations the move was politically motivated.

The pill in question is levonorgestrel, better known as Plan B or the "morning after" pill. On Thursday, the FDA informed the pill's maker that it can't be sold over the counter until more studies are done.

Critics said the latest action of the FDA, which ignores the advice of two expert advisory committees and the agency's own staff, was a triumph of politics over science. The American College of Obstetricians and Gynecologists went so far as to call it "morally repugnant," a "tragedy for American women, and a dark stain" on the agency's reputation.

The move ostensibly arose from concern that young teenagers would not be able to use the product safely. "We based our action primarily on the lack of data concerning use of this product among adolescents younger than 16," Dr. Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research (CDER), said at a press conference Friday. "The sponsors didn't contain any data on those under 14 and limited data on those 14 to 16."

"We're committed to working it through the system and making a determination," Galson added. "We're not shutting the door on it."

According to the New York Times, the FDA told Barr Laboratories, which makes the pill, that it must either find a way to prevent the younger age group from obtaining the product in stores or prove through studies that these girls could learn how to use the pill without help from a physician.

One of the issues, Galson stated, "was whether people would engage in riskier sexual activities because of availability."

"The issue that they're bringing up would almost be funny if they weren't serious," said Dr. Michael F. Greene, a member of one of the panels who voted in favor of the over-the-counter switch. The problem, according to Greene, is that it would be difficult if not impossible to get such information on this particular age group. For one thing, the pill will sell for $30, and it's hard to believe a 13-year-old girl could easily get "$30 a pop to abuse this stuff," said Greene, director of maternal fetal medicine at Massachusetts General Hospital in Boston.

"It's a ridiculous Catch-22. It's almost like a Monty Python skit," Greene continued. "They want data that they know is unobtainable."

The FDA originally approved Plan B as a prescription drug in 1999. In 2001, a group of more than 60 health groups petitioned the U.S. government to make emergency contraceptives available without a prescription and, in December 2003, FDA advisors concluded that Plan B was both effective and safe. They overwhelmingly recommended the agency make Plan B available without need for a prescription.

The FDA usually follows the advice of its expert committees, but in February it told Barr that it was delaying its decision. Galson said this move was "not unprecedented." Nor was it unprecedented for a director to disagree with recommendations from the staff, which also happened in this case, he added.

Greene strongly disagreed with Galson. "It's incredibly unusual," he said. "I'm not aware of any other situations where that's occurred."

Plan B consists of two tablets of levonorgestrel, which need to be taken within 72 hours of unprotected intercourse, but the sooner the better. Essentially, the drug prevents pregnancy by delaying ovulation. It does not interrupt an already implanted pregnancy.

An editorial in the April 8 issue of the New England Journal of Medicine strongly criticized the FDA's postponement of the decision.

For all the talk of safety, critics of the FDA's decision pointed to politics as a motivating factor for the decision. "The White House has now taken over the FDA," James Trussell, director of the office of population research at Princeton University and a member of the advisory board, told the New York Times.

In response, Galson said he was unaware of any meetings that had taken place at the White House and that he himself had not consulted with anyone outside the FDA about this issue. And while he had read letters from members of Congress, they did not sway the tide. "We focus on the scientific data when we make these difficult decisions," he said.

Barr Laboratories does not have to submit a new application, and it is unclear what kind of clinical trials it might need to undertake.

"We're unable to do a complete review on the additional supplemental application that we received from Barr that covered an access plan to provide the products behind the counter," Galson said. "Although we didn't have sufficient data to approve the application now, we're going to be working towards the expeditious evaluation of Barr's response."

Galson refused to state whether the FDA was interested in seeing oral contraceptives go over the counter.

"I'm not making that specific statement," he said. "We do think that provision and access to contraceptive products is important to public health, but I can't go to specific products' predictions or hopes."

More information

For more on Plan B, visit its official site. For more on emergency contraception, visit Planned Parenthood. Additional information on the action is available, in question and answer format, at the FDA.

SOURCES: May 7, 2004, press conference with Steven Galson, M.D., acting director, Center for Drug Evaluation and Research, U.S. Food and Drug Administration; Michael F. Greene, M.D., director, maternal fetal medicine at Massachusetts General Hospital, Boston; American College of Obstetricians and Gynecologists statement; New York Times
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