FDA Lags On Rule To Strengthen Protections For Patients Using Generics
Only makers of brand-name drugs have a legal duty to update their warning labels if they learn of new risks or side effects, the Supreme Court ruled five years ago. But that leaves millions of users in an unregulated safety gap.
Los Angeles Times:
New Warning Rule For Users Of Generic Drugs Is Left In Limbo
Five years after the Supreme Court blocked most personal-injury lawsuits against makers of generic drugs, a rule designed to strengthen patient protections have stalled, leaving what consumer groups warn is a safety gap for millions of users. After several delays, the Food and Drug Administration said last year it would to issue a new rule by the end of this month to require generic drug makers to update their warning labels in response to newly revealed risks. But the agency quietly said recently it had put off a final decision until early next year. (Savage, 7/21)