The Hill - Working Together for Patients

Op-Ed

By Reps. Michael C. Burgess and Brett Guthrie

Over the last few months, the Energy and Commerce Committee's Subcommittee on Health has held a series of hearings on the FDA's vitally important user fee programs. In these hearings, bipartisan support for a timely reauthorization of these programs has been clear. Our colleagues have spoken at length about their reauthorization being an important next step following passage of the game-changing 21st Century Cures Act, which became law in December. We could not agree more.

The user fee programs -- GDUFA, PDUFA, BsUFA, MDUFA -- may look and sound like wonky acronyms, but they are critical to patients, drug and device manufacturers, and the millions of Americans who work to deliver new treatments and cures to Americans. It's important to know what each user fee program does.

The Generic Drug User Fee Amendments (GDUFA) improve the fee structure to support small businesses, and provide goal dates for all outstanding generic drug applications. GDUFA also establishes priority review timelines for generic drugs. These reforms will help get lower-cost generic alternatives to patients faster.

The Prescription Drug User Fee Amendments (PDUFA) enhance the drug development process by making it more patient-focused and modernize the clinical trial process. PDUFA also dedicates staff to assist in the development and review of rare disease medications. These advances will improve the process for getting new drugs to market -- ultimately delivering new and innovative therapies to patients more quickly.

The Biosimilar User Fee Amendments (BsUFA) continue to build the biosimilars program and support guidance for product developers. Getting more biosimilars on the market will help lower health care costs.

The Medical Device User Fee Amendments (MDUFA) enhance the patient voice in the device development process and support the collection of real world data. MDUFA also improves the review process for low- to moderate-risk devices that are the first of their kind. These changes will help ensure the United States maintains its leadership role in advancing new medical devices to the market.

H.R. 2430, the FDA Reauthorization Act (FDARA) will reauthorize each of these important programs. Packaged together, it's easy to see how these policies can help deliver results for patients and retain our status as the global leader in medical innovation.

After 21st Century Cures, we know all too well that disease knows no bounds and that one way or another it touches us all. FDARA continues the important work outlined in Cures, delivering hope for patients by modernizing clinical trials, relying on real world data, and dedicating staff to assist in the development and review of medications for patients with rare diseases.

FDARA will also allow our medical innovations to continue to soar to new heights. All too often we hear stories about how laws or regulations have prevented these amazing medical advancements from being implemented. FDARA will help these ground-breaking treatments, drugs, and devices reach patients sooner, while also increasing competition in the marketplace.

Quite simply, FDARA will help patients live better and healthier lives.

In recent weeks, our subcommittee took an important step toward reauthorizing these important programs by advancing FDARA unanimously. Today, FDARA will come before the full Energy and Commerce Committee for consideration.

This is an important win for not just our country -- but our communities, families, friends and neighbors. It's imperative we continue to work in the spirit of bipartisanship on this and other initiatives. Patients are depending on it.

Michael C. Burgess, M.D. is chairman of the Energy and Commerce Health Subcommittee and Brett Guthrie is the Health Subcommittee vice chairman.

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