The medicine causes birth defects, including mental retardation. The new government program includes a requirement that people who use, prescribe and dispense Accutane enroll in a national registry as a way to tighten access to the drug. The computerized registry takes effect New Year's Eve.
The government is trying to keep Accutane and its generic competitors on the market, while ensuring that women who use the risky pills don't become pregnant. Critics see these curbs as the drug's last chance. For the past 20 years, there have been safety warnings and other restrictions, but pregnancies damaged by Accutane have continued.