WASHINGTON—The Food and Drug Administration unexpectedly announced its willingness Monday to make the emergency contraceptive, Plan B, available without prescription—but only to women ages 18 and older.
Monday's announcement is the most concrete indication to date that the FDA, after more than two years of delays, is nearing a final decision on the controversial application to sell the so-called "morning after pill" over the counter.
But lawmakers and women's rights activists, who have accused the agency of foot-dragging, remained skeptical because the decision isn't final and could be subject to more delays.
The move came one day before the Senate Health, Education, Labor and Pensions Committee holds a hearing on acting FDA Commissioner Andrew von Eschenbach's nomination to become the permanent head of the agency. The nomination won't be voted on because Sen. Hillary Rodham Clinton, D-N.Y., and Sen. Patty Murray, D-Wash., who are on the committee, have vowed to withhold confirmation until the FDA makes a final decision on Plan B.
In a letter to a subsidiary of Barr Pharmaceuticals, the maker of the drug, von Eschenbach said agency staff would meet with company officials within a week to iron out concerns over how to distribute, package and market Plan B. The drug is 90 percent effective in preventing pregnancies when taken within 72 hours of intercourse.
The FDA has determined that a time-consuming rule-making process, which can add years to an application request, won't be necessary "to resolve the novel regulatory issues" the case presents. If all goes well, the matter could be resolved within weeks, the FDA reported.
Barr, however, will have to amend its current FDA application, which seeks approval for non-prescription sales to females 16 and older.
"Because of enforcement considerations, we believe that the appropriate age for over-the-counter access is 18," von Eschenbach wrote.
Barr spokeswoman Carol Cox expressed optimism that the approval process was moving again.
"We are pleased to have received the letter from the FDA and are looking forward to meeting with the FDA very soon," Cox said.
But Clinton and Murray said that the FDA's announcement was "nothing more than another delay tactic."
"Rather than moving this process forward and doing right by the American people, the administration is continuing to play a game of smoke and mirrors the day before Dr. von Eschenbach's Senate confirmation hearing," they said in a prepared statement.
Eleanor Smeal, president of the Feminist Majority Foundation, agreed. "This is obviously not a coincidence," she said of the timing of the FDA announcement.
Emergency contraceptives have been sold by prescription in the United States since 1998. They're basically higher doses of the hormones that conventional birth control pills contain. They block the release of an egg from the ovaries or prevent a fertilized egg from being implanted in the walls of the uterus.
Two FDA advisory panels voted overwhelmingly to approve Plan B for sale without a prescription in December 2003, finding that the drug was safe and effective. But strong opposition by religious and conservative groups and the Bush administration has delayed final agency action on the measure for more than two years.
The FDA was first expected to decide the matter in February 2004 but requested more time to study adolescent use of the drug.
When the FDA missed another deadline in January 2005, Clinton and Murray blocked a vote on then-acting FDA Commissioner Lester Crawford's bid to become the agency's permanent chief. The senators dropped their opposition only after the Bush administration promised action on the measure by Sept. 1. Crawford was subsequently confirmed as FDA commissioner in July.
But in a highly unusual move in August 2005, Crawford deferred action on Plan B again, saying the drug was safe for women 17 and older but that issues surrounding its potential sale to younger teens remained unresolved. Crawford resigned the following month.
Kirsten Moore, president and CEO of the Reproductive Health Technologies Project, called the FDA's announcement a step in the right direction, but added, "Barr is being asked to jump through hoops that are probably impossible and clearly more politically than scientifically motivated."
(c) 2006, McClatchy-Tribune Information Services.
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