In the latest evidence that the Food and Drug Administration is ratcheting up its enforcement posture, the agency announced that it will require all patients taking the acne drug Accutane to enroll in a computer registry so that health officials can track their progress and watch for any potential side effects of the drug. Critics allege the drug, which is made by Hoffman LaRoche, carries a risk of increased suicidal behavior and can in some cases lead to birth defects.
Pharmacists will be required to check with the iPLEDGE registry before writing prescriptions. Doctors who wish to prescribe the drug will be required to register with the registry as well. Drugstores and wholesalers will also need to comply with the new rules. Drug industry critics see the step as an important one for the agency as it marks a significant tightening of its post-market approval policies.
- see this story from the Associated Press