Rather than pull Accutane from the market, Roche proposed an intense public education campaign. Convinced of the drug's therapeutic usefulness, FDA agreed. What followed is what many researchers consider one of the best education efforts for any drug. In addition, the company revised patient booklets and self-evaluation forms. We observed rates of pregnancy that are comparable with effective pregnancy-prevention efforts.
Most observers view it as a good first step.
We have watched what they've done. Still, even Roche's massive campaign leaves some researchers concerned about birth defects from Accutane. But I'm concerned that because participation in the survey was voluntary, we're getting the best-case scenario in terms of results. NCI's James Pluda, who is conducting thalidomide trials, plans to monitor pregnancy prevention. As with Accutane, thalidomide researchers must decide the best way to protect women who might become pregnant while taking the drug.