AARP Endorses Rep. Schiff’s Bill to Ensure Transparency, Safety in Generic Drug Labeling
Washington D.C. - The AARP has endorsed the Updated Drug Labeling for Patient Safety Act, legislation led by Representative Adam Schiff (D-Calif.) which aims to ensure transparency and safety in generic drug labeling.
In a letter, the AARP highlights its support for the Schiff-led legislation which would direct the Food and Drug Administration (FDA) to establish a process allowing generic drug manufacturers to update drug labeling, incorporating new or revised safety-related information. Schiff’s legislation would also require the FDA to issue and implement a final rule outlining a process for aligning the labeling of both brand name and generic drugs.
The potential risks and side effects of many prescription drugs may not be discovered until years after the drugs have been on the market. Current law mandates generic drug manufacturers to use the same labeling as their brand name counterparts. However, the FDA allows brand name drug manufacturers to update their labeling, while not affording the same autonomy to generic manufacturers.
“Americans must be able to trust that the information they receive about their medications is accurate and up to date,” said Rep. Schiff. “Unfortunately, right now patients can be misled by outdated safety information on generic drugs – which is the most common type of medication prescribed – because generics have to adopt brand name labeling that isn’t always up to date. The Updated Drug Labeling for Patient Safety Act will protect patients by ensuring they have the latest health safety information on their generic drug labels.”
Four out of five prescriptions in the United States are written for generic drugs, which are typically more cost-effective. Consequently, sales of brand name drugs often decline significantly after generics enter the market, providing little incentive for brand name manufacturers to update their labels. Many seniors might unknowingly be taking drugs with outdated safety information, and they have limited legal options if those drugs cause them harm.
AARP is the nation's largest nonprofit, nonpartisan organization dedicated to empowering Americans aged 50 and older.
The full bill text can be found here.
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