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Guthrie Introduces Legislative Package to Help FDA Fulfill Mission of Reviewing Drugs and Medical Devices

WASHINGTON, D.C. – Congressman Brett Guthrie (KY-02) and Congresswoman Anna G. Eshoo (CA-18) introduced the FDA Act of 2022, a package of bills to reauthorize the Food and Drug Administration (FDA) user fee agreements, secure supply chains, and lower drug costs.

Guthrie’s Pre-approval Information Exchange Act is included in this package and would help patients gain access to new medical innovation more quickly. It will help to reduce the time between the FDA approving a medical product and a payor covering the FDA-approved product by allowing manufacturers to communicate certain information about their product to payors prior to approval.

The FDA Act of 2022 will be considered on May 11, 2022, during a markup in the Health Subcommittee, which Guthrie and Eshoo serve as the Ranking Member and Chairwoman, respectively.

“User fee agreements developed between regulators and innovators and authorized by Congress are critical to support the FDA’s mission of timely reviewal of drugs and medical devices. The fees Congress authorizes the FDA to collect from industry provide the FDA with the resources needed to help get cutting-edge medical products to patients as quickly and as safely as possible. I’m pleased my Pre-approval Information Exchange Act was included, which will help to improve patient access to breakthrough therapies. I look forward to discussing this package during the Energy and Commerce Health Subcommittee markup this week,” said Guthrie.

Specifically, the FDA Act of 2022 reauthorizes the Prescription Drug User Fee Act (PDUFA), the Generic Drug User Fee Act (GDUFA), the Biosimilar User Fee Act (BsUFA), and the Medical Device User Fee Act (MDUFA) through 2027. Click HERE for legislative text. Click HERE for a section-by-section.

Additionally, at the Health Subcommittee markup this week, the Substance Use Prevention, Treatment, and Recovery Services Block Grant Act of 2022 will be considered. Guthrie is the lead Republican on this bill, which would deliver treatment and recovery support services to local entities providing services to individuals seeking help overcoming substance use disorder. This bill is part of the Restoring Hope for Mental Health and Well-Being Act of 2022, a legislative package introduced by Energy and Commerce Republican Leader Cathy McMorris Rodgers (WA-05) and Chairman Frank Pallone (NJ-06) to reauthorize Substance Abuse and Mental Health Services Administration (SAMHSA) and Health Resources and Services Administration (HRSA) programs.