FDA poses stricter regulations for the acne drug Accutane

• The regulations, which apply to generic versions of Accutane as well, require doctors and patients to register in an electronic database before it can be dispensed.
• Female patients of childbearing age must take two pregnancy tests and use two forms of birth control to get the drug.
• The new program is the latest and by far most drastic of more than 40 efforts by the agency in the last 22 years to reduce harm from Accutane, an oral medicine made by Roche Holding, while allowing its continued use.
• Health officials say the new plan is the latest sign the F.D.A. is losing faith that the nation's doctors and pharmacists can adequately safeguard the health of patients.
• Before 1998, the agency largely confined itself to advising physicians and pharmacists about how to prescribe and dispense safely any drugs with potentially dangerous adverse effects, and trusted that its advice would be followed.
• But experts say that time after time over the last decade, medical professionals have ignored the advice, providing drugs to patients at risk of severe complications.
• But such withdrawals have left stranded thousands of patients who contend that they needed those drugs to lead normal lives.
• Among the first was a program created in 1998 to ensure that thalidomide, infamous for causing thousands of birth defects in European babies during the 1960's, could be safely used as a leprosy drug.
• Dr. Wolfe added that drug companies were largely to blame, though, saying their huge marketing efforts often encouraged doctors to prescribe drugs excessively.
• By 2002, the last year before generic versions of the medicine entered the market, sales of Accutane in the United States had risen to $380 million, with doctors writing 170,000 prescriptions a month, half of which went to women.