Regulatory Focus™ > News Articles > Senator Plans to Introduce Legislation Reversing Mensing Decision

Senator Plans to Introduce Legislation Reversing Mensing Decision

Posted 29 March 2012 | By

Senator Patrick Leahy (D-VT) moved earlier this week (26-30 March) to introduce legislation to overturn a loophole exposed by a recent Supreme Court case that Leahy claims "threatens the safety of consumers taking generic drugs."

In Pliva v. Mensing, the Supreme Court ruled generic pharmaceutical manufacturers are not liable for tort claims based on labeling because federal law requires the drug's label to be identical to the Reference Listed Drug (RLD).

"The Mensing decision creates a troubling inconsistency in the law with respect to prescription drugs," said Leahy.  "If a consumer takes the brand-name version of drug, she can sue the manufacturer for inadequate warnings.  If the pharmacy happens to give her the generic version, she will not be compensated for her injuries."

"The result is a two-track system that penalizes consumers of generic drugs," concluded Leahy.

Leahy plans to introduce legislation "as early as this week" to overturn this discrepancy by allowing generics manufacturers to "improve the warning information for their products in the same way as brand manufacturers," said Leahy in a statement.

Read more:

Leahy - Leahy To Introduce Bill To Protect Consumers Who Take Generic Drugs

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