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FDA May Allow Generic Drugs to Update Label Information

FDA Proposes Rule for Generic Drug Manufacturers to Update Safety Info on Label

genericOn Friday, November 8th, the Food and Drug Administration proposed a rule that would allow generic drug manufacturers to update the labels on their products if a potential safety problem, with the generic or brand name drug, is discovered.

In June of this year, the Supreme Court upheld a 2011 decision that generic drug manufacturers were not liable for personal injury caused by their products, because generic drug companies must legally have the same safety labels as their brand-name counterparts. If a patient ends up with a personal injury due to safety problems with a drug they have been prescribed, they can sue the brand name manufacturer, but they cannot sue the generic drug company for misinformation about safety. Brand name companies, also, are able to independently update their safety and warning information, while generic drug companies have had to wait until new information about the original drug was released.

“Now, with the generic industry having grown up, most people are taking generic drugs,” said Dr. Janet Woodcock, the F.D.A.’s head of drug evaluation and research, in a telephone interview. “It’s really time to level the playing field.”

The FDA said the proposal was “intended to ensure that generic drug companies actively participate with F.D.A. in ensuring the timeliness, accuracy and completeness of drug safety labeling.”

The proposal could also hold generic drug manufacturers to many of the same safety testing standards as their brand name counterparts. Although problems related to active ingredients are known by the time the brand name drug loses its patent, side effects related to size of dose or inactive ingredients in the generic version are unknown.

“This is an important consumer protection provision,” said Representative Chris Van Hollen, Democrat of Maryland, who had supported such a change. “It’s a long time in coming.”

The generic drug industry’s trade group, the Generic Pharmaceutical Association, stated that it was concerned the proposed rule could create confusion. Ralph G. Neas, the association’s president, said in a statement that the group was “very concerned that multiple versions of critical safety information would lead to unnecessary confusion and uncertainty for prescribers and other health care professionals, with harmful consequences for patients.”

Mr. Neas also raised the question of whether the rule was legal. “The Supreme Court has repeatedly held that generic pharmaceutical manufacturers must duplicate the language on the brand pharmaceutical manufacturer’s labels and cannot make changes to a label without F.D.A. approval,” he said in the statement. “Therefore, the agency’s authority to enact a rule that differs from the federal law is unclear.”

The Strom Law Firm Helps with Personal Injury Cases Related to Brand or Generic Drugs

If you have been harmed, or a loved one has been harmed or killed by a defective product or drug, whether brand name or generic, the attorneys at the Strom Law Firm can help. You may be entitled to compensation through a personal injury lawsuit. We offer free, confidential consultations to discuss the facts of your case, so contact us today. 803.252.4800.



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