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When Generic Drugs Cause Injuries, Who Is Responsible?

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The FDA’s rule to make generic drugmakers accountable for inadequate safety labeling is under attack from the generics industry, and we need your help pushing the agency ahead. Click on this link to help right now: Holding Generic Drug Makers Accountable

Generic Drugs

The backstory: In the Mensing decision in 2011, SCOTUS said that a failure-to-warn suit against a generic drugmaker was preempted, which left generics makers unaccountable. In 2013, the FDA proposed a rule to enable generics manufacturers to independently update their safety labeling in response to new evidence of harms, and be taken to court if their warnings are inadequate.

But the rule has been delayed, and most recently the FDA reopened the public comment period on the rule. They also held a public meeting in March on the rule, and individuals harmed by generic drugs told FDA their compelling stories and spoke in favor of finalizing the rule.

An FDA official acknowledged our previous petition on the issue, which garnered roughly 20,000 signatures. We want to beat that number this time to show the agency the support it has to move forward.

Holding Generic Drug Makers Accountable

Please help us today by signing the petition, sharing it on Facebook, and promoting this positive change that will help make our families and communities safer.

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