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Generic makers oppose FDA rule, fear product liability

A large portion of people in Nashville rely on prescription and over-the-counter drugs on daily basis, so it can be very important for drug companies and federal agencies to keep the public informed about any potential risks that have been linked to these products. Many would also argue that when injuries and fatalities result from the use of dangerous or defective products, people should have the right to sue the manufacturer.

The Generic Pharmaceutical Association has come out in strong opposition to a proposed FDA regulation that would require generic drug manufacturers to update their labels independently. This trade group fears that the rule would result in the reversal of a Supreme Court decision that essentially granted generic manufacturers immunity from product liability suits. GPhA argues that these lawsuits will raise industry costs by $4 billion per year.

Advocates of the proposed rule claim that it is a necessary step that will provide physicians and consumers with proper notice of newly discovered risks. They argue that if generics are not required to change their labels and no brand-name alternatives are available, consumers will have no means of learning about dangers associated with using the product.

Drugs are now a part of many people’s daily lives, and sometimes they impart a lot of benefit. However, in instances where they result in consumer illness or worsened conditions that could have been prevented by a prescription drug recall or an altered label, many would argue that consumers should be able to sue the manufacturer. If you have been injured after consuming a dangerous or defective drug, you may want to consider speaking with an attorney about your legal options.

Source: The New York Times, “Updated Warnings for Generic Drugs,” Editorial Board, Mar. 26, 2014

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