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Carter leads bills to lower drug costs in E&C FDA Package

WASHINGTON, D.C. – The Energy and Commerce Committee unveiled its bipartisan package to reauthorize the Food and Drug Administration (FDA) User Fee Agreements. The package, introduced by Health Subcommittee Republican Leader Brett Guthrie (R-KY) and Health Subcommittee Chairwoman Anna G. Eshoo (D-CA), includes four provisions led by Rep. Earl L. “Buddy” Carter (R-GA) that would lower drug costs, modernize drug research and development, and reduce our reliance on China.

“This crucial package will lower drug costs, spur more lifesaving innovation, secure America’s supply chains, protect access to breakthrough drugs and therapies, and ultimately improve lives,” said Carter. “As a pharmacist, I understand how important it is that federal regulations enable safe, effective drugs to quickly come on the market. With these bipartisan bills, we achieve that goal without compromising on our world-class safety standards.”

The following bills with Rep. Carter’s sponsorship were included in the Food and Drug Amendments of 2022:

H.R. 4511, the FDA Advancing Collection of Transformative Science (FACTS) Act: Requires FDA to issue guidance on the use of real-world data and real-world evidence to support regulatory decision making for products previously granted an emergency use authorization. Also requires a report to Congress on how frequently and under what circumstances real world evidence was accepted to support an approval of a previously authorized drug or device.

H.R. 6973, the Enhanced Access to Affordable Medicines Act:
Accelerates patient access to affordable alternatives to brand name drugs by streamlining generic drug labeling and FDA approval processes for generic drugs.

H.R. 3927, the Manufacturing API, Drugs, and Excipients (MADE) in America Act:
Would address US supply chain vulnerabilities by incentivizing domestic manufacturing of drugs and active pharmaceutical ingredients (APIs), facilitating the use of novel manufacturing technologies, and enhances FDA inspections.

H.R. 2565, the FDA Modernization Act of 2021:
Allows an applicant for market approval for a new drug to use methods other than animal testing to establish the drug's safety and effectiveness.

The Energy and Commerce Health Subcommittee will hold a markup on the FDA Act next week.