Pallone and Eshoo Applaud House Passage of FDA User Fees Reauthorization Package
Energy and Commerce Committee Chairman Frank Pallone, Jr. (D-NJ) and Health Subcommittee Chairwoman Anna G. Eshoo (D-CA) released the following joint statement today after the House of Representatives passed the Food and Drug Amendments of 2022 (FDA22), which reauthorizes the Food and Drug Administration (FDA) user fee programs for prescription drugs, generic drugs, biosimilars, and medical devices, by a vote 392-28.
“The Food and Drug Amendments of 2022 will provide FDA with the funding it needs to carry out its mission of ensuring the safety and efficacy of prescription drugs and medical devices. The legislation will also facilitate the development of new medical products to treat rare diseases, help reduce the cost of prescription drugs by bringing more affordable generics to market sooner, and make sure clinical trials reflect the diversity of the patient population. It also addresses the current baby formula shortage and will help prevent future food safety crises by empowering the agency to hire much-needed technical staff across the entire FDA, including at the Center for Food Safety and Applied Nutrition.
“FDA22 also includes long-sought reforms to the accelerated approval program that will protect patients and provide FDA with the authority it needs to ensure approved drugs provide a clinical benefit. Additionally, the bill will help foster the development of cutting-edge continuous manufacturing technology by allowing FDA to partner with universities across the country to designate them as National Centers of Excellence in Continuous Pharmaceutical Manufacturing.
“Today’s strong bipartisan vote in the House puts us one step closer to getting a final bill to President Biden’s desk before August.”
H.R. 7667, the “Food and Drug Amendments of 2022,” was introduced by Eshoo and Health Subcommittee Ranking Member Brett Guthrie (R-KY) and unanimously passed out of the Energy and Commerce Committee last month. In addition to reauthorizing user fee programs, the bipartisan bill includes several key provisions that would:
- Reform the accelerated approval program by allowing FDA to require that sponsors begin post-approval studies before a drug goes on the market, providing greater transparency in drug labeling, and streamlining the process for FDA to remove products from the market when the sponsors have failed to act with due diligence to conduct studies or where studies have failed to show a benefit to patients;
- Improve clinical trials by requiring drug and medical device manufacturers to develop a clinical trial diversity action plan early in the development process that reflects the diversity of the patient population expected to use the product and submit the plan to FDA;
- Bring down the cost of prescription drugs by making it easier for more affordable generic drugs to come to market sooner; and
- Address the infant formula crisis and help prevent future problems related to food safety and supply by extending flexibilities to hire technical staff with competitive salaries throughout FDA, including to those overseeing food safety.