Coalition Letter To Senate HELP And Energy And Commerce Committee On User Fee Reauthorization Legislation

The Honorable Patty Murray                                     The Honorable Richard Burr

Chair                                                                             Ranking Member

Senate Health, Education,                                         Senate Health, Education,

Labor & Pensions Committee                                   Labor & Pensions Committee

Washington, DC 20515                                              Washington, DC 20515

The Honorable Frank Pallone                                    The Honorable Cathy McMorris Rodgers

Chair                                                                             Ranking Member

House Energy & Commerce Committee                 House Energy & Commerce Committee

Washington, DC 20515                                              Washington, DC 20515

Dear Chair Murray, Ranking Member Burr, Chair Pallone, & Ranking Member Rodgers:

On behalf of the Patient, Consumer, and Public Health Coalition, we are writing to again urge you to expeditiously reauthorize the Food and Drug Administration (FDA) user fee programs for medical products and include the essential, bipartisan, policy riders that will protect patients and consumers. It is critically important that your committees work together to consolidate differences between the two bills. This includes the Food and Drug Amendments Act (H.R. 7667), which passed the House of Representatives on June 8, and the Food and Drug Administration Safety and Landmark Advancements Act (S. 4348), which passed the Senate Health, Education, Labor, and Pensions (HELP) Committee on June 15. As you are well aware, these programs must be reauthorized by the end of the fiscal year and that deadline is swiftly approaching. 

We know there are significant differences between H.R. 7667 and S. 4348 with respect to policies added in addition to the user fee program reauthorization. This includes reform to the accelerated approval pathway, clinical trial diversity, and new oversight of dietary supplements, cosmetics, and lab-developed diagnostic tests. Now is the time for you to act to provide FDA with the tools, authorities, and resources needed to keep patients and consumers safe, while also ensuring medical products are able to reach patients quickly. We urge you to consider the following comments and recommendations as you finalize negotiations.

Accelerated approval

We appreciate the efforts from both chambers to reform the accelerated approval program. While this is an important pathway for access to new drugs, there is an urgent need for safeguards to keep patients protected from harmful and possibly ineffective treatments. A recent article published in JAMA found that the average launch price of accelerated approval drugs was $168,344 per person per year, compared to only $68,596 for other newly approved drugs.1 This makes it even more urgent to ensure the pathway is not abused and every step is taken to guarantee the drugs are safe and effective for patients. We enthusiastically agree with the approach from the two bills to require post-market studies to be underway prior to approval being granted and strongly recommend this provision be included in the final piece of legislation.

Lab-developed diagnostic tests

We strongly support several provisions included in S. 4348 to improve the regulation and oversight of lab-developed diagnostic tests. The revised language of the VALID Act in S. 4348 will provide the FDA with the authority and resources necessary to ensure that the highest-risk diagnostic tests are valid and reliable. We have seen the importance of diagnostic tests throughout the COVID-19 pandemic and the potential harm from an inaccurate result. In addition, increasing numbers of patients make life altering decisions based on diagnostic tests, which can include a cancer diagnosis or fetal abnormalities. Physicians are often unaware of the origin of the tests, assuming proper oversight has been conducted. The provisions of the VALID Act in S. 4348 will help give physicians the necessary assurances that the tests they are using on their patients are accurate.

Clinical trial diversity

We support the provisions included in H.R. 7667 to improve clinical trial diversity and recommend inclusion in the final bill. Lack of clinical trial diversity has resulted in the approval of treatments that are ineffective or inaccurate in some populations, further expanding inequities across the healthcare system. In addition, lack of older patients in many studies used as the basis of FDA approval has resulted in expensive Medicare coverage for treatments that are unsafe or ineffective for our nation’s elderly. Diversity must be addressed across the product lifespan and the provisions included in H.R. 7667 are an important first step by requiring drug and device manufacturers to submit diversity actions plans, although an enforcement mechanism would be needed to ensure goals included in the plans are met.

Additional policy improvements

We also strongly support the other provisions to protect patients and consumers, including a public database for dietary supplements, improving the regulation and oversight of cosmetics, and the banning of PFAS (a class of hazardous chemicals linked to cancer and other health risks) in food packaging. These commonsense policy solutions will reduce dangerous exposures and greatly improve the FDA’s ability to enhance the public health of all Americans.

We greatly appreciate the bipartisan efforts on this important piece of legislation. We urge you to continue to work together to carefully finalize the user fee reauthorization process with additional, bipartisan policy riders so the FDA has the tools and authorities to keep patients and consumers safe while continuing to bring new medical products to the market that are proven to be effective.


American Medical Student Association (University of Wisconsin Chapter)

Breast Cancer Action

DES Action USA

Doctors for America

Jacob’s Institute for Women’s Health

National Alliance for Hispanic Health

National Center for Health Research

National Women’s Health Network

Medical Device Problems

Medshadow Foundation

Patient Safety Action Network

TMJ Association

USA Patient Network


Washington Advocates for Patient Safety



Senator Chuck Schumer

Senate Majority Leader

Senator Mitch McConnell

Senate Minority Leader

Speaker Nancy Pelosi

Speaker of the House

Representative Kevin McCarthy

House Minority Leader

  1. Rome, B.N., Egilman, A.C., & Kesselheim, A.S. (2022). Trends in Prescription Drug Launch Prices, 2008-2021. JAMA, 327(21), 2145–2147. doi:10.1001/jama.2022.5542

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