April 29, 2021

The Honorable Sanford Bishop Jr. The Honorable Chairman, Appropriations Ranking Member, Appropriations Subcommittee on Agriculture, Subcommittee on Agriculture, Rural Development, Rural Development, Food and Drug Administration Food and Drug Administration and Related Agencies and Related Agencies 2362-A Rayburn HOB 2362-A Rayburn HOB Washington, D.C. 20515 Washington, D.C. 20515

Re: FDA Appropriations Request to Ensure Diversity in Clinical Trials

Dear Chairman Bishop and Ranking Member Fortenberry:

As you work to develop the FY2022 Agriculture Appropriations bill, we respectfully request you include $5 million in funding for the Food and Drug Administration (FDA) and related report language to ensure drug sponsors achieve diversity goals in clinical trials and end the underrepresentation of women and minorities. This will create better patient safety and drug efficacy.

We appreciate FDA’s efforts over the years to address this issue but recognize there are continued barriers that prevent diverse clinical trials – including recruitment, data reporting, and exclusions for pregnant and lactating women. These roadblocks perpetuate a research environment that fails to address how genetic differences based on gender, race and ethnicity interact with or exacerbate medical conditions and lead to adverse drug events (ADEs). ADEs disproportionately affect women, and currently no data is available based on ethnicity due to how reporting is conducted. Furthermore, according to a GAO report, approximately one‐fifth of new drugs approved between 2008 and 2013 elicited different responses across ethnic groups.

To address these concerns, we respectfully request that you consider including the following report language in the Agriculture-FDA Appropriations bill report:

The Committee commends the FDA for its recent guidance supporting increasing the number of women and minorities in clinical trials to represent their unique health needs, gather safety and efficacy information to inform proper product labeling, and prevent adverse drug events (ADEs), which are twice as high for women. However, incremental changes to address this problem have taken decades and are contributing to continued safety and efficacy issues for non-white male populations. The Committee supports broadening eligibility criteria, avoiding unnecessary exclusions from clinical trials, and improving recruitment, clinical trial designs and data reporting to reflect the U.S. population and include pregnant, lactating and women taking hormonal contraception. The FDA is provided with $5 million to establish and enforce minimum requirements for drug sponsors to ensure appropriate diversity in clinical trials and drug product labeling from sex-, race-, ethnicity- and gene-based pharmacokinetic differences in drug response. The FDA shall provide a report to the Committee within 180 days of enactment on each drug sponsor’s diversity enrollment plan for increasing the clinical participation of underrepresented populations, including women and minorities; addressing participation barriers, such as travel costs, timing for trial appointments, appointment locations, the use of online clinical care and other factors that often exclude diverse populations; and reporting data for drug product labeling that can prevent ADEs. This report shall include an analysis of the data gathered and how it impacts clinical trials, what has and has not been effective, and recommended best practices for drug sponsors.

Thank you for considering our request and past work with FDA to increase diversity in clinical trials to improve patient safety and ensure medication efficacy for the entire population. We respectfully request that you include this appropriation in your legislation to ensure equitable representation of women and minorities in clinical trials.

Sincerely,

______Madeleine Dean Lucy McBath Member of Congress Member of Congress

______Member of Congress

/S/ /S/ /S/ Nanette Diaz Barragán Terri A. Sewell Member of Congress Member of Congress Member of Congress

/S/ /S/ /S/ Nydia M. Velázquez Member of Congress Member of Congress Member of Congress

/S/ /S/ /S/ Mark DeSaulnier Member of Congress Member of Congress Member of Congress

/S/ /S/ /S/ Member of Congress Member of Congress Member of Congress /S/ /S/ /S/ Bobby L. Rush Grace F. Napolitano Member of Congress Member of Congress Member of Congress

/S/ /S/ /S/ Bobby L. Rush Diana DeGette Member of Congress Member of Congress Member of Congress

/S/ /S/ /S/ Jesús G. "Chuy" García Member of Congress Member of Congress Member of Congress

/S/ /S/ /S/ Raúl M. Grijalva Member of Congress Member of Congress Member of Congress

/S/ /S/ /S/ G. K. Butterfield Ann McLane Kuster Sharice L. Davids Member of Congress Member of Congress Member of Congress