FDA Turns Its Back on Women

FDA to ban a hormone that protects women from cancer. Action Alert! As we recently reported, the FDA is gearing up to issue a ban on compounded bioidentical hormone replacement therapy. The newest development is a report from the National Academies of Sciences, Engineering, and Medicine (NASEM), which falsely concluded that these critical medicines used by millions of women

FDA to ban a hormone that protects women from cancer. Action Alert!

As we recently reported, the FDA is gearing up to issue a ban on compounded bioidentical hormone replacement therapy. The newest development is a report from the National Academies of Sciences, Engineering, and Medicine (NASEM), which falsely concluded that these critical medicines used by millions of women are a “public health concern.” We must use every avenue available to fight the FDA and prevent a ban on estriol, progesterone, and other compounded bioidentical hormones.

The NASEM report was likely all part of the FDA’s ploy. NASEM’s mandate was to impartially review the “clinical utility” of treating patients with compounded bioidentical hormone replacement therapy (BHRT), yet the committee recommended that an FDA panel review bioidentical hormones for inclusion on the agency’s “Difficult to Compound List.”

This begs the question: What does clinical utility have to do with determining whether hormones are difficult for a pharmacist to compound? How would this group of doctors and researchers at NASEM even know what the Difficult to Compound List is, a relatively obscure regulatory process going on within the FDA? It seems obvious that the FDA made sure this recommendation was included in NASEM’s report.

There’s more evidence that the FDA carefully managed this entire process. You can read our previous coverage for more of those details. All of this together paints a clear picture: the FDA knew how this was going to end before it ever began. With an “impartial” report from the “experts” at NASEM, the FDA has given itself cover to ban compounded BHRT.

Hormones like estriol are critically important. Many studies have shown that estriol offers many potential health benefits—for urinary tract and bone health, for example—without some of the dangers that accompany higher-potency estrogens, such as cancer. A ban would cause suffering for many, many women. But banning compounded bioidenticals could have even wider implications—the FDA is trying to make it impossible for traditional pharmacies to stay in business. Many pharmacies rely on compounded hormones to stay open. If a ban does go through, pharmacies that manage to stay open will still have to grapple with all of the other draconian measures that are coming out of the FDA that severely limit interstate sales and savagely cut the type of ingredients that can be used in other medicines—safe natural medicines like curcumin, aloe vera, boswellia, and a host of others are likely to be banned from being made at traditional pharmacies.

It’s time to fight back.

Currently there is a request for comment at the FDA’s Office of Women’s Health (OWH) asking for input on what the office’s strategic priorities should be. According to the announcement: “To maximize FDA OWH’s ability to promote, protect, and advance the health of women, we are seeking input on research priorities driven by data gaps and areas of unmet need.”

Since NASEM concluded that there was insufficient “high-quality” evidence to determine the safety and effectiveness of estriol and other compounded hormones, perhaps the agency should put its money where its mouth is and support third party studies on compounded BHRT—clearly the FDA cannot be trusted to conduct any studies on the subject.

We should not let this opportunity to officially demand this research pass—a strong showing from patients and other concerned individuals can also demonstrate how many Americans care deeply about this issue and are fed up with the FDA’s hostility towards these treatments.

Attacking estriol and compounded hormones is just one of the ways the FDA and the federal government bolster drug monopolies and undermine natural health options. Taking action below sends a message to FDA’s OWH and also adds your name to our petition demanding that Congress reform a healthcare system that not only bars the use, but even the mention, of natural remedies like compounded bioidentical hormones that have not been, and never can be, put through the multi-billion dollar FDA approval process, because as natural substances they cannot be fully patented.

Action Alert! Sign our petition to reform our broken healthcare system, and send a message to OWH that they need to prioritize funding studies of compounded BHRT to protect women’s health. Please send your message immediately.