February 23, 2006

FDA Rejects Calls to Delay Acne Drug Limits

By Susan Heavey

WASHINGTON (Reuters) - The Food and Drug Administration on Thursday said it will implement new restrictions on a widely used acne drug next Wednesday in an effort to curb birth defects, rejecting calls from some doctors to delay the program.

Some doctors have said the revised limits on prescribing Accutane, sold by Switzerland's Roche AG but also available in generic form, are too cumbersome and take up too much time. Dermatologists had asked the agency to delay the program for two months while its flaws were fixed.

But the FDA said the program, called iPledge, would begin March 1 as planned.

More than 1 million prescriptions are written each year for Accutane, the only U.S.-approved drug for severe scarring acne. The drug also can cause serious birth defects or miscarriages.

Several programs have tried to prevent pregnancies among Accutane users since the drug was cleared in 1982, but more than 1,000 women have become pregnant while using it, according to the March of Dimes group, which aims to prevent birth defects.

Under the new plan, patients, doctors, pharmacists and drug wholesalers register electronically with drugmakers. Women of child-bearing age must sign consent forms and have monthly pregnancy tests, and doctors must tell patients about risks.

During the last few weeks, more than 1,200 patients every day have registered for the new program, the FDA said.

At an FDA advisory meeting earlier this month, doctors who started complying early with the program were critical. The cumbersome limits may also send some patients to the Internet to buy the drug -- a far riskier proposition, they said.

On Thursday, the FDA said it had worked to balance safety and access with drugmakers, pharmacists and Covance Inc., the company that will run the prevention program.

It has also taken steps to address doctor's concerns, including hiring more staff for the program's call center and changing the computer process to help registered users recover lost log-in information.

"FDA has ensured that rapid and significant progress has been made by the sponsors and Covance to address them," the agency said in a statement.

Mylan Laboratories Inc., India's Ranbaxy Laboratories Ltd. and Barr Pharmaceuticals Inc. sell generic versions of Accutane, known as isotretinoin.