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April 7, 2014

FDA Rule Change on Generics Will Benefit Lawyers but Hurt Patients

Lisa A. Rickard

A recent New York Times editorial, Updated Warnings for Generic Drugs, cites the two strongest reasons to oppose, not support, changes to the FDA’s drug labeling rules. The new rule would permit generic drugmakers to independently change the labeling on their products.

The bi-partisan Hatch-Waxman Act was passed in 1984 to encourage price competition and additional pharmaceutical research. It created clear, consistent rules for generic drugs and required them to be identical to the brand drugs that are rigorously scrutinized and approved by FDA scientists. This “sameness” requirement extends to drug labels.

The FDA acknowledges that changing its rules will increase the number of lawsuits against drug companies. According to news reports, the American Association for Justice, the plaintiffs’ lawyer lobbying group, met with FDA officials to convince them to make this rule change, in case there was any doubt of its benefit to plaintiffs’ lawyers.

A rule change would, however, be bad for patients. More lawsuits will drive up prices, and patients may be confused if identical drugs have different labels. Patients should be able to rely on a single national standard for drug labeling. An FDA rule change would take money from patients’ pockets and give it to lawyers.

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