The Food and Drug Administration announced the long-anticipated program Friday, more than a year after the agency's scientific advisers urged the extra curbs because repeated safety warnings have failed to stop Accutane-damaged pregnancies.
"We've been working on making the use of Accutane safe now for 22 years," FDA Commissioner Lester Crawford told The Early Show co-anchor Julie Chen. "We've had varied success. This program is about as tight as we can legally make it. It's what we call a risk-management program."
Both male and female patients will have to enroll in the registry, called iPLEDGE, by Dec. 31 or they can no longer receive Accutane.
"This is as strong as the FDA can get," Crawford said. "If a pharmacist, a wholesale drug company, or a physician does not wish to participate in this program, then they will not have access to the drug."
Women of childbearing age will have some additional steps: They're supposed to use two forms of birth control, get two negative pregnancy tests before their initial Accutane prescription, and show proof of another negative pregnancy test before each monthly refill.
Women already were supposed to be taking those steps, but by using the computerized registry system, doctors and pharmacists can ensure that that happens. One way: Each month, women will be required to enter into the registry, by phone or Internet, their two contraceptives.
All patients also must sign a document informing them of Accutane's risks, including the possibility that it contributes to depression or suicidal thoughts, a warning that FDA also strengthened on Friday.
But birth defects are the biggest concern with Accutane and its generic version, isotretinoin. The medicine is supposed to be prescribed only for severe acne but that critics say too frequently is given for more minor cases.
Since the drug began selling in 1982, the FDA has reports of well over 2,000 pregnancies among users. The vast majority ended in abortion, but the FDA counts more than 160 babies born with drug-caused defects. Critics note there likely were many more pregnancies because doctors haven't been required to report Accutane-linked pregnancies. Friday's new rules mandate that they do.
If a woman becomes pregnant while taking the acne drug, her baby can suffer severe brain and heart defects, mental retardation and other abnormalities, even if the mother took only a small dose for a short period. That's a risk for 30 days after stopping the drug, too.
Anyone who does get pregnant while taking the drug should stop the pills right away and notify her doctor, the FDA warns.
"The physician makes the determination whether or not they recommend intervention of the pregnancy," Crawford explained. "Then, the patient has the ultimate decision. If the patient is below the age of consent, this consultation will be done in the presence of their parents."
The registry actually opens on Aug. 22, giving users extra time to learn how it works before the provisions become mandatory at year's end. On that date, patients may enroll at www.ipledgeprogram.com or by phone at 1-866-495-0654. Wholesalers and pharmacies will have to register starting Oct. 31 or the drug's manufacturers can no longer ship them supplies of the pills.