Big Pharma is investing millions in the development of drugs to manage menopause. Is the FDA going to clear the market of compounded bioidentical hormone medicines to protect its paymasters? Action Alert!
- The FDA is approving new drugs for hot flashes brought upon by menopause.
- With Big Pharma setting its sights on menopause drugs, we fear the pressure will be even greater for the FDA to ban the competition: compounded bioidentical hormone replacement therapy.
- The FDA has already been stacking the deck against compounded hormones, so we need to keep the pressure on to make sure we retain access.
Big Pharma may be coming to the realization that there is a lot of money to be made in the management of menopause. Bayer just released positive results from two Phase 3 trials for a non-hormonal drug to treat hot flashes; this follows the approval of another menopause drug, Veozah, last Spring. This may all sound innocuous enough, but we fear that the more Big Pharma gets into the business of menopause drugs, the more pressure they will exert on the FDA to finish off the ban on compounded bioidentical hormone replacement therapy (cBHRT) that represent the competition.
The trouble is, the FDA may not need much persuading to clear the market of cBHRT products. As we’ve been reporting over the years, the agency has been on a long march toward a cBHRT ban. Several important bioidentical hormones (progesterone, testosterone, estradiol, and estriol) have been nominated to the “Difficult to Compound List.” If they appear on the final list, compounding pharmacies will no longer be able to make cBHRT products. Patients’ only choice will be FDA-approved hormone drugs, or perhaps this new generation of non-hormonal drugs.
We believe, and we’re fighting for, women to be able to make the choice to have compounded bioidentical hormones because these treatments are chemically identical to the hormones produced by the body. The conventional approach uses synthetic hormones like Premarin, an estrogen made from conjugated equine estrogen (CEE)—pregnant horse mares’ urine—or Prempro, which contains CEE and synthetic progesterone. Major studies have found that prolonged use of these synthetic products is associated with higher rates of coronary heart disease, breast cancer, stroke, and more.
Millions of women opt for bioidentical hormones, hormone products that are not only structurally identical to those produced by the body, but they’re also much better tolerated and utilized. These medicines are often made specially for individual patients at compounding pharmacies, although there are some FDA-approved bioidentical hormone products. A review of the clinical literature concluded that bioidentical hormones are associated with lower risks, including the risk of breast cancer and cardiovascular disease, and are more effective than synthetic or animal-derived hormones.
You don’t need to have a crystal ball to see that the FDA is planning an imminent cBHRT ban, which we will, of course, resist with all our combined might. You can read our previous articles for the story on how we’ve gotten to this point, but the overarching picture is that the FDA has carefully managed this process to produce the outcome it desires, which is a ban on cBHRT. Why? Because the FDA does not exert control over pharmacy compounded drugs—they don’t need to go through FDA approval, so they don’t, so to speak, “kiss the ring.”
Action Alert! Write to Congress supporting consumer access to cBHRT. Please send your message immediately.