Tell Congress & FDA: Protect People’s Access to 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. TAKE ACTION NOW
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:
Representatives Jaime Herrera Beutler (R-WA) and Jennifer Wexton (D-VA) are leading a Congressional letter to the FDA 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. They are trying to get their peers in Congress to cosign their letter right now.
Getting Congress involved in this fight is essential to protect access to these medicines.
Please fill out the form and click Send. This will automatically send the form letters to the FDA and your Congress representatives and senators, respectively. Feel free to share this on your social media accounts.
Tell Congress & FDA: Protect People’s Access to 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. TAKE ACTION NOW
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:
Representatives Jaime Herrera Beutler (R-WA) and Jennifer Wexton (D-VA) are leading a Congressional letter to the FDA 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. They are trying to get their peers in Congress to cosign their letter right now.
Getting Congress involved in this fight is essential to protect access to these medicines.
Please fill out the form and click Send. This will automatically send the form letters to the FDA and your Congress representatives and senators, respectively. Feel free to share this on your social media accounts.