Generic Drugs, Adverse Events, and Manufacturer Liability

Conner Mansfield, Mercer University College of Pharmacy 2016

The Alabama Supreme Court recently decided that brand manufacturers could be held liable when patients taking generic equivalents experience serious adverse events that the brand manufacturer didn’t warn against. Patients taking generic medications in other states generally have (under “Recent Court Decisions”) no recourse.

Patients deserve compensation if unduly harmed by a medication. However, brand manufacturers should not bear the responsibility of both all innovation and all liability involved with marketing a drug. Brand manufacturers would surely need to factor increased future liability into their pricing decisions. Additionally, the decision could complicate the withdrawal of off-patent medications.

Thankfully, the FDA plans to clarify their regulations. In December, the FDA rules on an amendment to equalize brand and generic labeling responsibilities. Currently, generic medications simply carry the exact same labeling as their branded parent.

Generic drugs exist to bring affordable treatments to market. Increased liability for generic manufacturers might cause an increase in the price of generic drugs. How should we balance patient protection with affordability?


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