The FDA’s Pharmacy Compounding Advisory Committee (PCAC) is holding another meeting, this time to decide the fate of resveratrol and pregnenolone, among other compounded medicines. Action Alert!
For some time now, we’ve been monitoring the FDA’s PCAC as it recommends which substances should be allowed to be compounded. Almost always, PCAC follows the lead of FDA staff in its recommendations.
The track record is appalling. PCAC has voted to ban many important natural medicines from compounding, including curcumin, boswellia, aloe vera, artemisinin, and nettle – all of which have been used safely for decades. Recall, too, that bioidentical hormones such as progesterone, estriol, and testosterone have been nominated for the Demonstrably Difficult to Compound list, meaning that these hormones are also on the chopping block and likely to be eliminated.
If estriol and others cannot be compounded, patients may not be able to obtain the bio-identical form of it in the proper cream base. Hormones like estriol should not be taken as a pill, but pharma companies prefer to make and sell pills. You can also be sure that even if available, the cost of estriol and other hormones will soar. The FDA has been trying for decades to eliminate compounded estriol, which is anti-carcinogenic, unlike the other estrogens which can be pro-carcinogenic depending on individual bio-chemistry. So far, ANH has stopped them from eliminating estriol. With your help, we will do so again.
PCAC’s next meeting will be on November 20-21. Astragalus (an herb used in Chinese medicine for its anti-inflammatory properties), pregnenolone (a precursor hormone with many important functions), and resveratrol (an antioxidant found in grape skins with many health benefits), among others will be reviewed. Pharma is particularly eager to get control of resveratrol, which has so many uses in natural healthcare, and which cannot be accessed in sufficient dosage from diet alone.
The Committee will also make a recommendation on whether liposomal delivery systems (when a vitamin or nutrient is encased in tiny phospholipid structures) or products produced using extrusion are too difficult to compound.
From the beginning, it’s our belief that the goal of this process has been to hamstring and eventually drive out of business traditional compounding pharmacies by eliminating the types of medicines they can produce. The FDA wants traditional pharmacies to register as “outsourcing facilities,” since the agency has virtually total control over their operations and they will likely be owned by Pharma. Few traditional pharmacies have wanted to become this new kind of facility because they know it would end their independence.
We cannot stand idly by as the FDA eliminates traditional compounding. Click the button below to take action.
Action Alert! Send a message to the FDA and PCAC, urging them to maintain access to these safe and beneficial medicines. Please send your message immediately.
