Letter to Hon. Xavier Bacerra, Secretary of the US Department of Health and Human Services, BIPARTISAN GROUP OF CONGRESSIONAL LEADERS URGES BIDEN ADMINISTRATION TO CONTINUE ADDRESSING NEEDS OF PREGNANT AND LACTATING WOMEN

Letter

January 21, 2022
The Honorable Xavier Becerra
Secretary
U.S. Department of Health & Human Services
200 Independence Avenue, S.W.
Washington, D.C. 20201
Dear Secretary Becerra,
We are writing to urge you to extend the charter of the federal Task Force on Research Specific
to Pregnant Women and Lactating Women (PRGLAC), which expired in March 2021, or to
establish another advisory committee with a similar range of expertise.
Each year, nearly four million women in the U.S. give birth, and more than three million
breastfeed their infants. According to the National Institutes of Health (NIH), although more than
90 percent of pregnant women report taking a medication during pregnancy, only 1 percent of
clinical trials mention the words "pregnancy" or "pregnant," and only 0.5 percent mention
"lactation." Not enough is known about the effect of most drugs during pregnancy. For example,
the rate at which certain drugs are excreted through the kidney may increase by 50 percent
during pregnancy. Women with chronic diseases, such as diabetes, hypertension, depression, and
asthma need safe and effective medications to manage these ongoing conditions throughout their
pregnancy and beyond.
Without reliable data, those who are pregnant or nursing may decide to stop taking necessary
medications, increasing risks for both mother and child. In other cases, some may choose not to
initiate breastfeeding or may wean earlier than desired because they lack information about the
extent of drug transfer into human milk, the potential impacts of the drug on milk production,
and the impact of exposure to the infant. Even when drug safety data is available, such data is
usually limited, and often does not address how the changes of pregnancy and breastfeeding will
affect dosage.
In the context of COVID-19, clinical trials for treatments and vaccines largely excluded pregnant
and lactating women, leaving them and their clinicians without clear evidence on safety and
efficacy to guide clinical decision-making.
We can and must do better for pregnant and lactating women.
To address this problem, in 2016, Congress established PRGLAC under the 21st Century Cures
Act to identify and address gaps in knowledge regarding safe and effective therapies and
vaccines for pregnant and lactating women. In 2018, PRGLAC released a Report to Congress
that included 15 detailed recommendations to promote the inclusion of pregnant and lactating
women in clinical trials. Following release of these recommendations, then-HHS Secretary Alex
Azar extended PRGLAC's charter through March 2021 for the Task Force to create an
implementation report, released in August 2020 (PRGLAC Implementation Plan).
Although the development of the PRGLAC recommendations and Implementation Plan marked
progress on this issue, much work remainsto improve treatment options for pregnant and
lactating women. PRGLAC's charter expired on March 13, 2021. To ensure continued
implementation of PRGLAC's recommendations, in the Fiscal Year 2022 Appropriations Filed
Report, the Labor, Health, Human Services, Education, and Related Agencies Subcommittee
included the following language to encourage the implementation of these recommendations:
Research on Pregnant and Lactating Women.--The Committee encourages the
Secretary to work with the NIH, FDA, the Office of Human Research Protections
(OHRP), and other relevant agencies to implement recommendations from the Task
Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC).
The Committee encourages the Secretary to direct NIH and FDA to implement
guidance and templates surrounding the inclusion of pregnant and lactating
individuals within clinical trials in order to require justification for the exclusion of
these populations within clinical trials, and to clarify that exclusion of these
populations within clinical trials should not be the default practice in the
development and evaluation of drugs and therapeutics. The Secretary should work
with OHRP and FDA to harmonize FDA regulations with changes to the protected
status of pregnant women in federally funded research included in the 2018
revisions to the Federal Policy for the Protection of Human Subjects.
Toward accomplishing this end, we urge you to extend PRGLAC's charter or establish
another advisory committee with a similar range of expertise to ensure continued
implementation and monitored progress of the steps recommended by PRGLAC. Oversight
from a dedicated group of experts is needed to continue to make progress in establishing
therapeutic options for pregnant and lactating women.
We thank you for your swift attention to this issue. We look forward to hearing from you on your
Department's progress implementing PRGLAC's 2020 report and your plans to ensure continued
implementation and monitor progress. If we can be of further assistance, please contact Becca
Flikier in the Office of Congresswoman Lois Frankel at Becca.Flikier@mail.house.gov or (202)
441-1667.
Sincerely,

___________________ ___________________ ___________________
Lois Frankel Jaime Herrera Beutler Lucille Roybal-Allard
Co-Chair Co-Chair Co-Chair
Democratic Women's Caucus Caucus on Maternity Care Caucus on Maternity Care
__________________ ___________________ ___________________
Alma S. Adams, Ph.D. Jake Auchincloss Nanette Diaz Barragán
Member of Congress Member of Congress Member of Congress
__________________ _________ __________ _________/s/________
Suzanne Bonamici Shontel M. Brown André Carson
Member of Congress Member of Congress Member of Congress
___________________ ___________________ ___________________
Ed Case Kathy Castor Judy Chu
Member of Congress Member of Congress Member of Congress
___________________ ___________________ ___________________
David N. Cicilline Gerald E. Connolly Danny K. Davis
Member of Congress Member of Congress Member of Congress
___________________ ___________________ ___________________
Madeleine Dean Diana DeGette Mark DeSaulnier
Member of Congress Member of Congress Member of Congress
___________________ ___________________ ___________________
Ted Deutch Veronica Escobar Adriano Espaillat
Member of Congress Member of Congress Member of Congress
___________________ ___________________ ___________________
Brian Fitzpatrick Raúl M. Grijalva Sheila Jackson Lee
Member of Congress Member of Congress Member of Congress
___________________ ___________________ ___________________
Eddie Bernice Johnson Henry C. "Hank" Johnson Robin L. Kelly
Member of Congress Member of Congress Member of Congress
___________________ ___________________ ___________________
Derek Kilmer Ann Kirkpatrick Ann McLane Kuster
Member of Congress Member of Congress Member of Congress
___________________ ___________________ ___________________
Rick Larsen Brenda L. Lawrence Al Lawson
Member of Congress Member of Congress Member of Congress
___________________ ___________________ ___________________
Barbara Lee Andy Levin Ted W. Lieu
Member of Congress Member of Congress Member of Congress
___________________ ___________________ ___________________
Carolyn B. Maloney Kathy Manning Lucy McBath
Member of Congress Member of Congress Member of Congress
___________________ ___________________ ___________________
Betty McCollum A. Donald McEachin Grace Meng
Member of Congress Member of Congress Member of Congress
___________________ ___________________ ___________________
Gwen S. Moore Seth Moulton Jerrold Nadler
Member of Congress Member of Congress Member of Congress
___________________ ___________________ ___________________
Marie Newman Jamie Raskin Linda T. Sánchez
Member of Congress Member of Congress Member of Congress
___________________ ___________________ ___________________
Mary Gay Scanlon Jan Schakowsky Jackie Speier
Member of Congress Member of Congress Member of Congress
___________________ ___________________ ___________________
Darren Soto Melanie A. Stansbury Marilyn Strickland
Member of Congress Member of Congress Member of Congress
___________________ ___________________ ___________________
Mark Takano Paul Tonko Norma J. Torres
Member of Congress Member of Congress Member of Congress
___________________ ___________________ ___________________
Lori Trahan David Trone Lauren Underwood
Member of Congress Member of Congress Member of Congress
___________________ ___________________ ___________________
Marc Veasey Debbie Wasserman Schultz Bonnie Watson Coleman
Member of Congress Member of Congress Member of Congress
___________________ ___________________
Jennifer Wexton Nikema Williams
Member of Congress Member of Congress
Cc:
Dr. Dorothy Fink, Deputy Assistant Secretary for Women's Health, HHS, Director, Office on
Women's Health;
Dr. Lawrence A. Tabak, Acting Director, National Institutes of Health;
Dr. Janine Austin Clayton, Director, NIH Office of Research on Women's Health, Associate
Director for Research on Women's Health, NIH
Dr. Janet Woodcock, Acting Commissioner, Food and Drug Administration
Dr. Jerry Menikoff, Director, Office for Human Research Protections
Ms. Jennifer Klein, Co-Chair and Executive Director, White House Gender Policy Council
Ms. Carole Johnson, Administrator, Health Resources and Services Administration