An advisory committee is meeting to make recommendations to the FDA on whether or not to ban certain supplements from being made at specialized pharmacies.
On September 12, the FDA’s advisory committee on compounded medicine—medicine made for individual patients at specialized pharmacies—will meet to discuss five ingredients: alpha lipoic acid, CoQ10, creatine monohydrate, pyridoxal 5 phosphate (P5P), and quercetin dihydrate. If the agency doesn’t hear from patients and concerned citizens, we may lose access to individualized preparations of these important dietary ingredients.
The Pharmacy Compounding Advisory Committee (PCAC) advises the FDA in writing new rules regarding what supplements and drugs can be made individually for patients with specific needs by compounding pharmacies. PCAC has met a handful of times over the last few years, and as we’ve noted elsewhere, the track record is not good. The committee has voted to ban almost every dietary ingredient put before it, including curcumin, boswellia, and aloe vera—usually following the FDA’s recommendation. It’s important to note that PCAC meetings are one step in the FDA’s process; to ban an ingredient from compounding requires publishing a proposed rulemaking, which the public can comment on and voice concerns about.
Some of the substances being considered in September are extremely important:
- Alpha lipoic acid is a potent antioxidant that can protect against oxidative stress and the production of free radicals, one of the underlying causes of diabetes. It’s been found to help with diabetic neuropathy, nerve damage that occurs as a result of the toxic effects of high glucose levels on the nervous system in people with diabetes. Alpha lipoic acid offers a number of other benefits, including reducing blood pressure, reducing insulin resistance, protecting against cataract formation, preventing bone loss, removing toxic metals from the body, and more.
- Quercetin, a polyphenol found in red wine, garlic, apples, and green vegetables, is another antioxidant with many health benefits. It can modulate inflammation, which is involved in almost every chronic disease. It’s been shown to reduce the replication of viruses. It helps with cardiovascular disease and metabolic syndrome, among many other ailments.
- CoQ10 is an antioxidant that the body produces naturally and that cells use for growth and maintenance. It has many well-documented health benefits, including benefits for heart failure patients, guarding against age-related disorders and cancer, preventing the onset of migraines, and more.
- P5P is a form of vitamin B6. It is essential to human life—all forms of B6 must get converted to P5P for the body to use it. It’s known for its role as an anti-glycation agent. Glycation arises when sugars react with proteins to generate advanced glycation end products (AGEs) which result in cataract development in the eyes, reduced kidney function, damage to blood vessels, and sagging and wrinkling skin as we age.
If the FDA bans any or all of these ingredients, it will once again be turning its back on patients with special needs. One of the main purposes of compounded medicine is so that patients with allergies, patients who have difficulty swallowing pills, patients who require specialized formulations not available elsewhere, such as autistic children, or patients who require other modifications to the dietary ingredients and medicines available in the market can get the individualized treatments they need. For example, an FDA-approved product may have peanut oil in it, so patients could go to a compounding pharmacy to get a peanut-free medicine. Restricting the list of ingredients available to compounders will make life harder for these patients.
The main motivation behind the FDA’s attacks on compounded medicine is to protect the pharmaceutical industry from competition. With no other choice, patients who rely on compounded medicine would have to buy Big Pharma’s drugs. We can’t let them whittle away the ingredients allowed to be compounded. This “death by a thousand cuts” could end access for us to compounding pharmacies altogether.