Millions of individuals take hormones to sustain a normal, active life. While hormonal imbalance is most commonly associated with perimenopause and menopause, the condition can affect women, men, and trans people of all ages. It manifests through a wide range of symptoms that, for many, can be devastating.
 
Hormone replacement therapy has been a powerful treatment that allows millions of people to live normal lives. But the typical FDA-approved therapies can't serve all people. For example, there are no manufactured bioidentical hormone therapy products available on the market for certain diseases, such as female sexual dysfunction (“FSD”) and gender dysphoria.
 
Many patients need customized medications. Some patients may be allergic to a component in an FDA-approved drug, such as lactose, gluten, or a dye. Patients who cannot swallow a tablet or capsule (e.g., elderly patients, children) may need a compounded medicine in a liquid dosage form. A patient may need an exact strength or dosage form that is not commercially available. A patient may need a drug that has been discontinued by the manufacturer.
 
Federal law recognizes that it is impossible for drug manufacturers to meet every conceivable patient need, and that certain patients cannot be treated even with an FDA-approved medication. This means compounding pharmacies play an essential role in keeping people healthy.

A 2020 FDA-funded report on compounded hormones from the National Academies of Sciences, Engineering and Medicine recommends across-the-board restrictions on compounded hormones. These restrictions would undermine physicians’ professional judgment and interfere with the practice of medicine and could prove catastrophic for millions of patients who benefit from those therapies. But that NASEM report is compromised by potential bias, conflicts of interest, and bad science.

Most, if not all, of the NASEM committee members lacked any real-world experience prescribing and dispensing compounded hormones to patients. In essence, the committee was asked to develop recommendations on a topic in which they had little or no expertise. But the biggest flaw in the NASEM report is the committee's decision to ignore the vast bulk of patient-outcome research on compounded hormones.

It avoids, almost willfully, any discussion of the patients who are served by this important therapy. Nowhere does it consider the firsthand experience of patients (or their physicians and pharmacists) who rely on this essential therapy. The report dismisses, almost out of hand, the idea that compounded hormones help millions of people live normally.

As part of its commission, NASEM was to review the body of patient-outcome studies for compounded hormones. NASEM chose to ignore that data, instead selecting only 13 studies to include in its report, mostly featuring hormones that are not among the most commonly prescribed. (Studies that matched their predetermined outcome?)

One meta-analysis of patient outcomes, published in Menopause, the journal of the North American Menopause Society, is exactly the kind of unbiased research that NASEM should have done but didn't. While limited in scope, the study reveals that compounded hormones provide real benefits to patients and also finds no increased risk compared to FDA-approved products.

Most people who take compounded hormones began by taking the FDA-approved, manufactured drugs first. And for a variety of reasons, those therapies weren’t appropriate. By the time a physician prescribes a compounded hormone, patients are typically suffering significantly and have found no relief in the mass-produced solutions. Compounded hormones are not an alternative; for millions of people, they are the only viable option.
 
The NASEM report is dubious at best, misleading at worst. The conclusions that the committee made, the recommendations that follow, risk long-term, significant patient harm to millions of people and a severe intrusion on physicians' ability to care for their patients.
 
Compounded hormones are an important medical therapy that millions of people depend on. It must be protected.

If you aren't getting relief from your hormone replacement therapy, talk to your doctor about compounded options.

Millions of people in the U.S. depend on compounded medicines to live normal, productive, healthy lives. Their first-hand stories speak directly to the power of this important therapy. As the FDA considers removing access to certain medicines like compounded hormones, their voices must be part of the conversation.