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Accutane

Recommendations to Improve Patient Safety

  1. Conclusive Research
    • Roche should commit to underwriting all necessary independent controlled studies on Accutane's risks of depression, suicidal ideation, suicide and other psychiatric disorders. Such studies should be designed in collaboration with the Food and Drug Administration (FDA) and be conducted by independent investigators.
    • Congress should secure additional funding for post-market research and surveillance at FDA and at the Agency for Health Research and Quality (AHRQ).
  2. Better Information
    Until conclusive research has been completed:
    • All Accutane patients should receive and sign an informed consent form clearly warning of Accutane's risks of depression, suicide and other psychiatric disorders every time the physician prescribes the drug.
    • FDA should immediately ensure that Accutane labeling and boxes display the same warnings as the physician package insert of Accutane's risks of birth defects and of depression, suicide and other psychiatric disorders.
    • FDA should immediately issue a patient "MedGuide" with clear and prominent warnings of Accutane's risks of birth defects and of depression, suicide and other psychiatric disorders.
    • Roche should make immediate public disclosure of all U.S. and international serious Accutane adverse drug reactions (ADRs), and commit to sharing all future serious Accutane ADRs with the FDA and the public within 21 days of their receipt.
    • Roche should immediately notify FDA of any international regulatory action (e.g. new warnings).
  3. Moratorium on Direct-to-Children Advertising
    Until conclusive research has been completed:
    • Roche should commit to refraining from direct-to-consumer (DTC) and direct-to-children Accutane advertising, or agree to prominently disclose Accutane's risks of birth defects and depression, suicide and other psychiatric disorders in all such print and electronic advertising.
    • FDA should investigate whether Accutane is being over-prescribed and determine the impact of direct-to-children advertising on any such prescribing.

If FDA does not have the authority to take any of these actions, they should immediately request the authority from Congress.