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.