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FDA Targets the Labeling of Generic Drugs

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Sarah Kim3 years ago

According to Reuters, the U.S. Food and Drug Administration (FDA) defended its proposal which would require drug-making companies to update prescription information on their productions.

Companies state such measures would increase the number of product liability lawsuits and costs.

FDA Proposed New Labeling Requirements

In 2011, the Supreme Court ruled that companies producing generic drugs should not be accountable for failure to warn against risk in their labels.

Unlike consumers taking brand-name drugs, consumers taking generic drugs may not be able to take legal recourse. Moreover, only brand companies can update labels even though the generic drugs are the same as their counterparts.

At a hearing before a U.S. House of Representatives health subcommittee, Dr. Janet Woodcock, the FDA's top pharmaceuticals official, said they intend to “create parity” between branded and generic drug makers regarding labeling changes.

Woodcock states the proposition would require both branded and generic manufacturers to be responsible for the labeling and quality of their products.

Generic Drug Companies Cite Higher Prices

Generic drug companies are attempting to block the proposal by claiming that the new regulations would result in price increases for all generic drugs.

Ralph Neas, president of the Generic Pharmaceutical Association, claims that as generic drug manufacturers are exposed to “substantial new tort liability costs,” they would be required to adjust prices and withdraw products to stay in business.

Allison Zieve rebuked the claim stating that as long as generic drug manufacturers are up to date on their labeling, now lawsuits will be filed. According to Zieve, because the regulations will help prevent injuries from occurring in the first place, it will also result in less liability claims.


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