news

Washington, DC – Today, U.S. Representatives Jennifer Wexton (D-VA) and Jaime Herrera Beutler (R-WA) sent a bipartisan letter urging the Food and Drug Administration (FDA) to preserve access for millions of women and other patient populations to compounded hormone therapy treatment options.

Wexton and Herrera Beutler are taking action in response to a recent report from the National Academies of Science, Engineering, and Medicine (NASEM) which contains several concerning recommendations which, if implemented, would limit or eliminate access to important compounded hormone therapies. These therapies aid in the well-being and quality of care for millions of women and other patients, especially for those going through menopause, seeking treatment for fertility challenges, or facing other hormonal imbalances.

“Compounded hormones are critical to help women across the country seeking medical assistance for common issues like fertility treatment and menopause,” said Congresswoman Jennifer Wexton. “After learning about this potential restriction in access from concerned constituents, I’m proud to take bipartisan action to protect millions of Americans’ ability to receive compounded hormone therapies. It’s essential that a patient and their physician be able to make decisions that are personalized to their unique health needs.”

The letter emphasizes the value of compounded medicines and the importance of a prescribing physician’s ability to uniquely tailor and personalize medications to meet the needs of their patients.

Research shows that up to 2.5 million women in the U.S. 40 years of age or older may rely on compounded hormones like estriol, estradiol, and progesterone. Compounded medicines are often used by medical providers to meet a patient’s individual needs, such as a different dosage level, delivery method, or a combination of hormones than what is included in manufactured products.

In addition to Wexton and Herrera Beutler, the letter was also signed by Representatives Julia Brownley (D-CA), Michael C. Burgess, M.D. (R-TX), Earl L. “Buddy” Carter, R.Ph. (R-GA), Kathy Castor (D-FL), Peter DeFazio (D-OR), Neal P. Dunn, M.D. (R-FL), Brian Fitzpatrick (R-PA), H. Morgan Griffith (R-VA), Diana Harshbarger, Pharm.D. (R-TN), Ron Kind (D-WI), John R. Moolenaar (R-MI), Markwayne Mullin (R-OK), Gregory F. Murphy, M.D. (R-NC), Gary Palmer (R-AL), Chellie Pingree (D-ME), Mark Pocan (D-WI), C.A. Dutch Ruppersberger (D-MD), Chris Stewart (R-UT), Beth Van Duyne (R-TX), and Bonnie Watson Coleman (D-NJ).

The full text of the letter can be found here and below:

December 14, 2021

The Honorable Janet Woodcock, MD
Acting Commissioner
Food and Drug Administration 
10903 New Hampshire Avenue
Silver Spring, MD 20993

Dear Acting Commissioner Woodcock:                            

Millions of women and other patient populations have come to rely on compounded hormone therapies, and we are writing to urge you to preserve access to these treatment options. We have heard from constituents who are deeply concerned that they may lose access to medications they have relied on for years if FDA considers implementing the recommendations contained in a July 2020 report by the National Academies of Sciences, Engineering, and Medicine (NASEM).

If implemented, the recommendations in the report, titled The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use, would limit and in some cases eliminate access to these critical compounded medications. These recommendations would interfere with the practice of medicine and prevent practitioners from treating their patients with therapies that they determine are best for their patients.  The most egregious recommendation asks FDA to consider placing hormones on the “demonstrably difficult to compound list,” which would make it unlawful to compound with these ingredients.

Continued patient access is key.  The NASEM report acknowledges that “[m]illions of men and women use cBHTs to alleviate symptoms associated with age-related hormone changes, such as hot flashes in menopause, or low muscle mass due to decreased testosterone.”  Given the multitude of patients, including many of our constituents, who are prescribed these medications, we urge the Agency to cautiously approach this issue in order to avoid disruption of treatments and the potential elimination of this important option.

Compounding provides personalized medicine.  Though there are a limited number of FDA-approved bioidentical hormonal drug products on the market, those medications are not uniquely tailored to individual needs.  Because of this, medical providers often prescribe a compounded alternative with a different dosage level, a different delivery method, or a different combination of hormones than what is included in manufactured products.  Indeed, some patients may have an allergy or intolerance to a manufactured product, which would necessitate a compounded medication.  Access to compounded medications provides the ability for a prescribing physician to uniquely tailor and personalize medications to meet the needs of their individual patients.

We ask that you please take these key considerations into account, and craft patient centered policies that preserve current treatment options. Thank you for your consideration. We look forward to your response.

Sincerely,

###