Tell Congress & FDA: Protect People’s Access to Affordable Compounded Hormone Therapies

Please join us in sending a letter urging the Food and Drug Administration (FDA) and Congress to preserve access to compounded hormone therapies for millions of people in the United States.

The FDA is currently considering to include estradiol, estrone, estradiol cypionate, estriol, pregnenolone, progesterone, testosterone, testosterone cypionate, and testosterone propionate and all pellet cBHT therapies as candidates for the “Difficult to Compound List.”  This will mean that production of all compounded hormone injections, gels, creams, nasal, oral, and pellet formulations will be banned, blocking affordable access to millions of people in the United States.

TAKE ACTION NOWAfter you fill out your information, our site will automatically send form letters on your behalf to the FDA and Congress, respectively. Feel free to share this page on your social media accounts. We are aiming at over 5,000 signatures.

Brief Background:

A few years ago, the FDA commissioned the National Academies of Sciences, Engineering, and Medicine (NASEM) to generate a report to assess the clinical usefulness of compounded hormone formulations.

The NASEM Committee submitted such report in July 2020 and found “no clinical usefulness” of compounded hormone formulations. It also recommended that estradiol, estrone, estradiol cypionate, estriol, pregnenolone, progesterone, testosterone, testosterone cypionate, and testosterone propionate and all pellet hormone therapies be considered candidates for the FDA “Difficult to Compound List.” Items that appear on the final list will be barred from pharmacy compounding. The FDA is currently deciding whether these hormones should remain on the list and be banned.

A review of the NASEM report found strong conflict of interests, biases, and deficiencies in how they arrived at the conclusion that compounded HRT has “no clinical value.” Also, the creation of a list of hormones that are “difficult to compound” did not involve any compounders that have been making these formulations for over 40 years.

Attacking compounded hormones to clear the market for FDA-approved hormone drugs is just one of the ways the FDA and the federal government bolster drug monopolies and undermine affordable treatment options. The FDA clearly prefers all medicines to go through its drug approval process requiring clinical trials, because drug user fees constitute 45 percent of the agency’s annual budget. The problem is that clinical trials for compounded bioidentical hormones are not feasible. The whole point of compounded medicine is that it is tailored to individual patient needs. There are countless preparations of bioidentical hormones that are used for the millions of women who rely on these medicines; does the FDA expect clinical trials for every single hormone preparation that is compounded? No one will pay for these trials because hormones have been used for decades are not strongly patentable.

The FDA still needs to go through the rulemaking process before hormones are banned from compounding, but the time to act is now. We must get Congress on our side to try to reign in this agency by getting as much support behind this sign-on letter as possible.

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. It is estimated that over 6 million people rely on compounded hormones like estriol, estradiol, testosterone, progesterone, DHEA and others. These hormones are particularly important for patients going through menopause, fertility challenges, or other hormonal imbalances like hypogonadism.

Two Representatives in Congress Are Leading the Way and Need Support:

In an effort to head off any plans FDA might have to restrict compounded hormones, U.S. representatives Jaime Herrera-Butler (R-WA) and Jennifer Wexton (D-VA) are circulating a “Dear Colleague” memo to the rest of the House emphasizing the critical importance of continued access for all to compounded bioidentical hormones urging the FDA to craft patient centered policies that preserve access to current treatment options.

A bipartisan letter is a start, but they’ll need a lot more signatures for it to have an impact.

You can — you need to — help. By Taking Action, you will be able to contact your member of Congress to ask them to co-sign the “Bipartisan Letter to Protect Women’s Access to Compounded Hormones” circulated by representatives Herrera-Butler and Wexton.

Getting Congress involved in this fight is essential to protect access to these medicines.

To get more details on this issue, visit: The FDA May Soon Block Your Access to Affordable Hormones



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