WASHINGTON, D.C. – This week, Congresswoman Doris Matsui (D-CA) and Congressman Brett Guthrie (R-KY) introduced the 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This legislation would allow the U.S. Food and Drug Administration (FDA) to require modifications of outdated generic drug labels to reflect new information such as new uses or safety information.
“Patients and their prescribers rely on FDA-approved product labels to contain accurate and safe prescribing information. The MODERN Labeling Act will make sure that Americans have access to reliable, high quality sources of information to help make the right health care decisions,” said Congresswoman Matsui. “Prescription drug labels are the most readily available and trusted sources of drug information, yet the current FDA regulation limits modernizing many older treatment labels to reflect the latest clinical evidence. Passing this bipartisan bill will strengthen the role labels play in informing treatment decisions, safeguard our public health, and facilitate greater use of lower-cost generics.”
“We live in a country with constant medical innovation and new studies that give us updated information about the effectiveness of drugs. However, current FDA labeling requirements mean that labels for many generic drugs with off market brand sponsors are not updated with new information. The MODERN Labeling Act will help ensure that patients and doctors are informed with pertinent information regarding a drug. I was proud to introduce this commonsense legislation with Rep. Matsui,” said Congressman Guthrie.
“FDA drug labels are intended to be the most accessible, unbiased and factual sources of information about drugs – but for diseases that treatments are evolving at a rapid pace, a drug label can quickly become outdated. We applaud Representatives Matsui and Guthrie for their bipartisan leadership on this important bill that will ensure physicians and patients have the most accurate information when making treatment decisions,” said Dr. Jeff Allen, President & CEO, Friends of Cancer Research.
“As a physician, I consult the information in FDA labels frequently in my practice because they’re a trusted source of unbiased information. Often, the information about a medication’s dose, the conditions it treats, its side effects and safety monitoring are either missing or out of date — especially for older generic medications. Other online references are usually more reliable. But from my patients’ perspective, out-of-date FDA labels often block access to these prescriptions because insurance companies and Medicare rely on FDA approval as a condition for coverage, and generic drugs are often proved effective for conditions without obtaining FDA approval. By helping to keep FDA labeling up to date, this legislation would not only put important information at physicians’ fingertips, but also help Americans obtain coverage for safe, effective prescriptions they need,” said Dr. Angus Worthing, former Chair, Government Affairs Committee, American College of Rheumatology.
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 usage and safety information that emerges from subsequent clinicals or in the post-market setting. A problem occurs when a branded 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 will help to maintain up-to-date generic drug labels by creating a process that allows FDA to require updating of labels to reflect new information relevant to the drug and its use when the approved label has been withdrawn.
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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