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WASHINGTON, D.C. – Congressman Brett Guthrie (KY-02), top Republican on the House Energy and Commerce Committee’s Subcommittee on Oversight and Investigations, has introduced the MODERN Labeling Act to modify how certain generic drug labels are updated.

Congressman Guthrie introduced this legislation with Congresswoman Doris Matsui (CA-06).

“We live in a country with constant medical innovation and new studies that give us updated information about the effectiveness of drugs,” said Guthrie. “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. This is especially important for cancer patients, who rely on new studies for the latest information on what could work for their treatment. I was proud to introduce this commonsense legislation with Rep. Matsui.” 

Under current FDA regulations, drug manufacturers are required to update a drug label when it becomes inaccurate, false, or misleading. However, labels do not often incorporate information from new studies about the effectiveness of the drug, such as new uses for the drug to treat other diseases. Additionally, once older drugs have gone off patent, or even off the market there is no incentive for drug makers to update the labels – and generics must reflect the labels of the original brand drugs label.

The Health Subcommittee will hold a hearing on the MODERN Labeling Act tomorrow. The subcommittee will also look at two other Guthrie bills: The Safeguarding Therapeutics Act and the National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act. 

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