The FDA has already banned three old generic compounded fertility hormones and is now actively considering blocking access to eleven affordable compounded hormone replacement products. Please read the summary below so that you can understand the two issues that affect millions of people in the United States that are trying to improve fertility, health, and quality of life with hormone replacement therapy. Please join us in taking action as indicated at the end of this article. Feel free to share this information on social media to spread the word.
ACCESS ISSUE NO. 1: THE FDA HAS BANNED COMPOUNDED FERTILITY HORMONES
After producing affordable alternatives to name-brand fertility hormones like hCG, FSH and HMG for over 40 years, compounding pharmacies have been told by the FDA to stop selling these products. According to the FDA, a new law that was intended to decrease prices and improve access to “Biologics” (what these hormones are called) now requires these pharmacies to apply to produce them as new drugs via an expensive and lengthy process.
Under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) – Protein-based drug products like hCG, FSH, and hMG that had been approved over 25 years ago as “drugs” are now considered “Biologics” and now fall under the jurisdiction of the FDA’s Center for Biologics Evaluation and Research (CBER). These three compounds are gonadotropins that have been used in fertility and hormone replacement in women and men. Compounding pharmacies have been compounding urine-derived hCG, FSH, and hMG and increasing patient access to these medications for over 50 years. Under the new law, compounding pharmacies are no longer allowed to make these products unless they go through a new lengthy and costly “Biologics Licensing Application (BLA).” TELL THE FDA TO REVERSE ITS DECISION!
Developing a BLA is a costly and lengthy process that is required for new research products that are considered for FDA approval. Having old products like hCG and FSH be required to go through this new process is counterproductive and presents barriers to access to patients who have been using these products for years to improve their quality of life and their chances to start a family.
Compounders have been compounding urine-derived hCG, FSH, and hMG and increasing patient access to these medications for nearly 50 years. For example, hCG and FSH will still be the same drugs that they were in 1973 and 1983 when they were approved by the FDA. Patients should not suffer due to access issues as a result of a purely regulatory change.
The FDA decided to take this action while costs have been increasing dramatically. A new GoodRx analysis has found that prices for name-brand in vitro fertilization (IVF) medications (hCG, FSH, and HMG) have steadily climbed since 2014. The average cost of name-brand-based IVF is about $23,000 per cycle, whereas compounded-based IVF was only $2,700. Most couples need at least 3 IVF cycles. The out-of-pocket cost and lack of insurance coverage for IVF, along with the sole reliance on name-brand medications, create an insurmountable hurdle for people. Even if one could afford them, shortages and backorders of expensive brand-name hCG and FSH at regular pharmacies are common.
If FDA does not reverse its decision to again make these old medications regulated as “drugs” for purposes of Section 503A and Section 503B of the Federal Food, Drug, and Cosmetic (FD&C) Act, significant disruptions to patient access to these fertility and hormone replacement options will continue to increase.
It is now time for taxpayers to speak up!
ACCESS ISSUE NO. 2: THE FDA IS CONSIDERING BANNING 11 OTHER COMPOUNDED HORMONES USED IN HORMONE REPLACEMENT THERAPY
The FDA is currently considering including 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 the 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.
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 a 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.
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 and men 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 that 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 also get Congress on our side to try to reign in this agency by getting as much support 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, gender reassignment or other hormonal imbalances like hypogonadism. Name-brand products are not only expensive but they also don’t provide customization of hormone blends for patients who need specific ratios and delivery methods.
TAKE ACTION NOW!
Please help us to tell the FDA to reverse its decision on fertility hormones and to ask them not to ban access to customized hormone formulations used in hormone replacement therapy for millions of people. You will also have the opportunity to inform your Congress representatives and senators about these two issues.
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