ICYMI: Sen. Marshall Secures Wins to Lower Health Care Costs, Advance Innovation in FDA Package

(Washington, D.C., June 22, 2022) – Last week, the Health, Education, Labor & Pensions (HELP) Committee held an Executive Session and passed several health care bills championed by U.S. Senator Roger Marshall, M.D. aimed at increasing access to low cost medicine and innovative medical products. Senator Marshall’s bills and amendments were included in a comprehensive package called the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act (S. 4348). 

“Developing new medical advancements goes hand and hand with making health care more affordable for Kansans and all Americans,” said Senator Marshall. “Although I am disappointed my colleagues added in provisions that would harm innovation, I am optimistic my additions to the FDASLA Act make it a stronger piece of legislation.”

FDASLA aims to reauthorize the U.S. Food and Drug Administration (FDA) user fee agreements and also reforms the diagnostic regulatory structure. Senator Marshall’s initiatives that were added to the FDASLA include:

• Section 501 – Alternative Research Methods. Building on Senator Marshall’s questioning during the HELP Committee’s April 5 hearing, this section allows the use of 3D bioprinting to support preclinical development instead of testing on animals.
• Section 504 – Improvements to the Purple Book. Modelled after Senator Marshall’s bipartisan Biologics Market Transparency Act (S.4302), this section would give physicians and patients critical information they need to make treatment decisions that are best for them, including helping plan for potential drug shortages.
• Section 506 – Modernizing accelerated approval. Building on Senator Marshall’s bipartisan legislation, The FACTS Act (S. 1508), this section would allow the use real world evidence to augment and support approval of drugs aimed to address serious conditions that fill an unmet medical need under the Accelerated Approvals Program.
• Section 605 – Reauthorization of the exclusivity of drugs containing single enantiomers. Modelled after Senator Marshall bipartisan legislation, the Hatch-Waxman Improvement Act of 2022 (S.4378), this section would reauthorize market exclusivity for drugs containing single enantiomers through 2027.
• Section 908 – Regulation of certain products as drugs. Modeled after Senator Marshall’s bipartisan, the CLEAR Act (S. 4333), this section would clarify the FDA’s authority to regulate “combination products” – products that meet both the definition of drugs and devices. It eliminates unnecessary confusion and turmoil in the industry and free up valuable time and resources within the FDA.

Two amendments authored by Senator Marshall were also adopted by voice vote during the markup:

• Marshall Amendment #3: Require the FDA to make reasonable efforts to evaluate third-party research on medical devices that is used for regulatory decision-making; and to the extent practicable, provide the manufacturer(s) a summary of such information. The purpose is to clarify the FDA’s authority and ensure transparency and ensure the data is accurate on reporting adverse events or user error.
• Marshall Amendment #5: Require GAO to evaluate the unique considerations for hospital-based laboratories, laboratories serving academic medical centers, and other health care practitioners on the effect of the VALID Act. The report is due within three years of enactment which provides time for Congress to respond ahead of the FDA issuing final guidance. The purpose is to address concerns expressed by molecular pathologists and other clinicians regarding the impact the VALID Act will have on their ability to provide access to care while acknowledging the need for meaningful diagnostic regulatory reform.

Unfortunately, some members of the HELP Committee included amendments that would kill innovation and stymie the FDA’s responsibility in ensuring safe and effective medical products. Senator Marshall joined several of his colleagues in voting against the package, as amended.

During the Executive Session, Senator Marshall also voted to pass the following bills out of the HELP Committee:

• Retirement Improvement and Savings Enhancement to Supplement Healthy Investments for the Nest Egg (RISE & SHINE) Act (S. 4353)
• Maximizing Outcomes through Better Investments in Lifesaving Equipment for (MOBILE) Health Care Act (S. 958)
• Cardiovascular Advances in Research and Opportunities Legacy Act (H.R. 1193)
• Early Hearing Detection and Intervention Act of 2022 (S. 4052)

A Senator Marshall amendment to the RISE & SHINE Act would require the Secretary of Labor to conduct a study on the impact of inflation on retirement savings. It was adopted by voice vote.

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