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Health Subcommittee Approves Three Guthrie Bills

Washington, March 11, 2020

WASHINGTON, D.C. – The House Energy and Commerce Committee’s Health Subcommittee today approved three bills introduced by Congressman Brett Guthrie (KY-02): The MODERN Labeling Act, Safeguarding Therapeutics Act, and the National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act.

The MODERN Labeling Act, which Congressman Guthrie introduced with Rep. Doris Matsui (CA-06), will allow generic drug companies to update their product labels for new drug indications when a brand name drug is no longer on the market. This bill will ensure doctors and patients are informed with updated information on certain drugs.

“Congresswoman Matsui, committee staff, my staff, and I have been working hard to ensure that labels of generic drugs can be updated to help patients receive the best possible care,” said Guthrie at the subcommittee markup. “I’m glad we have been able to work in a bipartisan way on this bill and look forward to this bill moving to the full committee.”

The Safeguarding Therapeutics Act, which Congressman Guthrie introduced with Rep. Eliot Engel (NY-16), will give the Food and Drug Administration (FDA) the authority to seize and destroy counterfeit medical devices and products such as vaccines and other combination devices that could seriously harm patients. The FDA currently has the authority to destroy counterfeit drugs, but not medical devices. Guthrie saw counterfeit devices firsthand at the International Mail Facility at John F. Kennedy Airport.

“At the International Mail Facility located at JFK Airport we saw that the FDA has the authority to destroy counterfeit drugs, but not counterfeit medical devices. If the drugs were packaged or contained within a counterfeit medical device, agents said that they had to return the devices to the return address, and sometimes they saw the  exact same counterfeit device come right back through the screening facility,” said Guthrie at the markup. “This bill would give the authority to the FDA to destroy illicit medical devices and will strengthen our supply chain.”

In 2016, Guthrie helped author the 21st Century Cures Act, a comprehensive bill to help treat and find cures for diseases. It included legislation to issue grants for institutions of higher education to study the process of continuous pharmaceutical manufacturing. Guthrie joined full committee Chairman Frank Pallone (NJ-06) to introduce the National Centers of Excellence in Continuous Manufacturing Act to continue this partnership.

“Continuous manufacturing could help with drug shortages that we now face. I believe this bill is crucial in order to ensure Americans have access to medicine they may need when they need them,” said Guthrie.

Now that the MODERN Labeling Act, Safeguarding Therapeutics Act, and the National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act have all been approved unanimously by the Health Subcommittee, they must now be approved by the full House Energy and Commerce Committee before heading to the full House of Representatives for a vote.

 

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