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Public Citizen: Generic Drug Labeling Regulations Need to be Changed

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The watchdog group Public Citizen is calling on federal regulators to revise a number of laws so generic drug manufacturers can update product labels to warn patients about the potential for side effects. Current regulations enforced by the U.S. Food & Drug Administration (FDA) stop generic manufacturers from updating product labeling in a way that varies from the brand-name version, even if the generic maker learns of a new problem. To connect with an experienced defective drug lawyer, fill out the confidential contact form below for a free consultation.

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What’s the problem?

August 29, 2011 - In what Public Citizen calls an ‘illogical’ federal regulation, generic drug manufacturers cannot currently update their products’ labeling, even if they become aware of a potential risk not stated on the label. Brand-name drug companies, on the other hand, are allowed to update warnings and precautions on product labeling before obtaining FDA approval. Generic drug makers are required to match labeling with their name-brand counterparts.

Over the past quarter century, the production of generic medications has skyrocketed. Today, generic drugs constitute the vast majority of all prescriptions filled in the United States. Last year, nearly 90% of prescriptions filled were for generic drugs. Taking these figures into consideration, generic manufacturers have access to a great deal of information about product safety and effectiveness. According to Public Citizen’s petition, these generic companies should have the same ability as brand-name companies to revise labeling with the best available information about the safety of their products.

This glaring disparity was highlighted in the June 2011 U.S. Supreme Court ruling in the case of PLIVA v. Mensing, which held that patients harmed by inadequate warnings on a generic drug cannot sue the manufacturers for damages, while people harmed by name-brand versions can. Justice Sonia Sotomayor called the ruling an ‘absurd consequence.’

"Drug safety would benefit if generic manufacturers – who already have access to real-world information about adverse events – could use FDA procedures currently in place for brand-name manufacturers to revise labeling to warn of risks," said Dr. Sidney Wolfe, director of Public Citizen Health Research Group. "Filling this regulatory gap would help to protect patients."

Taking funding and staff shortages into consideration, federal regulators currently have extremely limited resources to monitor the tens of thousands of drugs on the U.S. market. Accordingly, the FDA has been forced to trust pharmaceutical manufacturers to police themselves in identifying previously unknown risks.

Public Citizen submitted an amicus brief in the PLIVA v. Mensing case, stating that it is critical for generic pharmaceutical manufacturers to respond to new safety information because potential side effects often do not become apparent until years after a medication has been on the market. The petition also urges the FDA to highlight the need for generic drug manufacturers to inform the administration whenever it becomes aware of new data suggesting a potential hazardous side effect not mentioned on a drug’s labeling.

"The action we are requesting would bring FDA regulation in line with the realities of the pharmaceutical market and help to ensure that drug labeling provides adequate warnings to patients based on information that comes to light after the drug is approved for marketing," said Allison Zieve, director of the Public Citizen Litigation Group.

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