Newly unveiled FDA user fee agreement package includes 4 bipartisan Carter-sponsored bills

A comprehensive bill to reauthorize the Food and Drug Administration (FDA) user fee agreements introduced last week by a bipartisan group of U.S. House Energy and Commerce Committee members includes four bipartisan bills led by U.S. Rep. Buddy Carter (R-GA).

“This crucial package will lower drug costs, spur more life-saving innovation, secure America’s supply chains, protect access to breakthrough drugs and therapies, and ultimately improve lives,” Rep. Carter said. 

H.R. 7667, introduced on May 6 by bill sponsor U.S. Rep. Anna Eshoo (D-CA) and three cosponsors, including U.S. Rep. Cathy McMorris Rodgers (R-WA), would amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, according to the text of the bill.

The measure contains four bipartisan bills with Rep. Carter’s sponsorship: the FDA Advancing Collection of Transformative Science (FACTS) Act, H.R. 4511; the Enhanced Access to Affordable Medicines Act of 2022, H.R. 6973; the Manufacturing API, Drugs, and Excipients (MADE) in America Act, H.R. 3927; and the FDA Modernization Act of 2021, H.R. 2565.

H.R. 4511, which Rep. Carter cosponsored in July 2021 with U.S. Reps. Michael Burgess (R-TX) and Angie Craig (D-MN), would establish that certain data and determinations from a request for emergency use authorization for a drug, biological product or medical device may apply to later regulatory procedures for that product, according to the congressional record bill summary.

H.R. 6973, which Rep. Carter sponsored on March 8 with original cosponsor Rep. Craig, would amend the Federal Food, Drug, and Cosmetic Act to clarify the conditions under which the U.S. Secretary of Health and Human Services may approve generic drug applications with labeling temporarily different than the brand name drug, according to the text of the bill.

Rep. Carter in June 2021 also sponsored H.R. 3927 with eight original cosponsors, including U.S. Reps. Tom Rice (R-SC) and Darren Soto (D-FL), to incentivize domestic manufacturing of drugs and active pharmaceutical ingredients, facilitate the use of novel manufacturing technologies, and enhance FDA inspections. 

H.R. 2565, which U.S. Rep. Vern Buchanan (R-FL) introduced in April 2021 and which Rep. Carter cosponsored, would allow 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 congressional record bill summary says. It notes that these alternative methods may include cell-based assays, organ chips and microphysiological systems, sophisticated computer modeling, and other human biology-based test methods.

“As a pharmacist, I understand how important it is that federal regulations enable safe, effective drugs to quickly come on the market,” said Rep. Carter. “With these bipartisan bills, we achieve that goal without compromising on our world-class safety standards.”

The U.S. House Energy and Commerce Health Subcommittee plans to hold a markup of the main legislative package, H.R. 7667, this week.