WASHINGTON, D.C. — Today, the House of Representatives voted to pass Congresswoman Doris Matsui’s (D-CA) Making Objective Drug Evidence Revisions for New (MODERN) Labeling Act, a bipartisan bill to ensure that providers, patients and their caregivers have the most up-to-date information about the prescription drugs they use.
This legislation would allow the U.S. Food and Drug Administration (FDA) to require modifications of outdated labeling for generic drugs to reflect new information, such as new indications or safety-related information discovered after post-market use.
“Despite the important role prescription drug labels play in informing treatment decisions, many generic drug labels are considerably out of date. When making health care decisions for themselves and their loved ones, it is vital that Americans and their providers have access to accurate, up-to-date information about a drug’s safety and efficacy,” said Congresswoman Matsui. “This legislation responds to the public health issue of outdated labels by creating a new pathway for FDA to update generic drug labels once a brand reference drug has left the market. By modernizing drug labels, we can preserve this trusted source of information, enhance patient benefit, and facilitate greater use of lower-cost generics. I applaud my colleagues in the House for approving this bipartisan legislation and I urge the Senate to do the same.”
Under current law, a generic drug is required to have the same label as its brand reference product. However, over time, a drug’s label may not reflect new indications and safety-related information discovered after post-market use. A problem occurs when a brand reference product is no longer on the market, leaving generics to rely on a label that cannot readily be updated. As such, many generic drug labels are considerably out of date, despite the critical role they play in helping health care providers prescribe treatments safely and effectively.
The MODERN Labeling Act addresses the public health issue of outdated labels for certain types of generic drugs by giving FDA the authority to require updating of labels to reflect new information relevant to a drug and its use.
Supporters of the MODERN Labeling Act include:
Alliance for Aging Research
American Association for Cancer Research (AACR)
American Cancer Society Cancer Action Network (ACS CAN)
Cancer Support Community
Children’s Cancer Cause
Fight Colorectal Cancer
Friends of Cancer Research
GO2 Foundation for Lung Cancer
National Alliance on Mental Illness
National Comprehensive Cancer Network (NCCN)
National Multiple Sclerosis Society
National Organization for Rare Disorders
St. Baldrick’s Foundation
Susan G. Komen
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