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Complaints won't delay FDA acne drug program


WASHINGTON -- The Food and Drug Administration said yesterday that it is moving ahead with a program to prevent pregnant women from accidentally taking an acne drug that can cause birth defects, despite complaints about the program from doctors and pharmacists.

The agency said that "rapid and significant progress has been made" to address the concerns, and that it will launch the program, iPledge, on Wednesday.

The program will require that to receive the drug isotretinoin, women of childbearing age register, test negative for pregnancy every month and use contraceptives.

The drug, best known as Accutane and also sold as Amnesteen, Sotret and Claravis, is considered a highly effective treatment for severe and disfiguring acne. As many as 200,000 people use it each month, the FDA said.

Studies have found that the drug can cause birth defects and fetal deaths, and might cause depression and suicide. Nevertheless, 150 to 200 women a year become pregnant each year while taking the drug, the FDA said.

The new program is the latest effort to prevent pregnant women from inadvertently taking the drug. Women, doctors and pharmacists began registering by telephone on Dec. 30.

Doctors and pharmacists have complained of confusing instructions and long waiting times on the phone. On Feb. 10, an American Academy of Dermatology representative told an FDA advisory panel that the program was a "disaster" and requested a two-month delay in starting it.

Dr. Clay J. Cockerell, the academy's president, condemned the planned March 1 start of the program and issued a statement expressing "serious disappointment."

"Flaws and inefficiencies in the program have not been sufficiently addressed prior to its launch," he said.

Dr. Sidney Wolfe, director of health research at the liberal group Public Citizen, dismissed the opposition as the latest effort by dermatologists to block restraints on sales. Wolfe said a program such as iPledge wouldn't be necessary if dermatologists stopped prescribing the drug to patients who don't need it.

He urged the FDA to take the even stronger step of removing the drug from the market and allowing it to be sold only to patients in closely watched clinical trials.

"There's massive over-prescribing," Wolfe said. To seriously cut down on the number of women taking the drug while pregnant, he said, "you need massive reductions in prescriptions."

In a statement, the FDA said Covance Inc., the Princeton, N.J., company that is to run the program, and the four manufacturers of the drug had taken steps to upgrade registration.

Those steps include improving the system that processes requests for new passwords and increasing the staff at the call center that accepts registrations and answers questions.

The FDA said more than 1,200 patients a day have been registering over the past few weeks. As of Monday, more than 27,000 women had registered, the FDA said.

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