Legislation has been introduced to protect patient access to customized natural medicines. It needs our support. Action Alert!
Representative Morgan Griffith (R-VA) has reintroduced a bill to ensure continued consumer access to customized natural medicines made at specialized pharmacies (known as compounding pharmacies). While other challenges remain, the Preserving Patient Access to Compounded Medications Act is an important step toward curbing the attack on these important natural medicines.
The Act does several important things. It amends section 503A of the Food, Drug, and Cosmetic Act (which pertains to “traditional” pharmacies, as opposed to larger “outsourcing” facilities) to unequivocally permit “office use” of compounded drugs, which allows a doctor to keep a supply of certain medications in his or her office in order to provide immediate treatment to patients who need it. For example, without office use, a patient in extreme pain would have to wait for days, get his or her prescription filled, and then return to the doctor for an
The bill also mandates the FDA to accept USP monographs for dietary supplements. This is a pivotal issue. In order to be made into a customized medicine, a substance has to meet one of three criteria. It must either:
- appear on an FDA pre-approved list (the Bulk Drug list);
- have a USP monograph; or
- be a component of an approved drug.
In 2016, the FDA, with no explanation or justification, stated that it would not accept supplement USP monographs. This meant that in order to be used in customized, natural medicines, supplements had to be nominated for the FDA’s pre-approved list. Many supplements were nominated, but, no surprise, the FDA rejected them: even a supplement, however, like curcumin, with very important medical uses. Behind the scenes, of course, Pharma is trying to turn curcumin or a synthetic analogue into a drug.
The bill also clarifies the definitions of “dispense” versus “distribute.” This seemingly trivial distinction is actually of great importance, as it directly affects how many medicines a traditional pharmacy can send out-of-state. “Distribution” references sending compounded medicines interstate when there isn’t a specific patient prescription, as in the case of office use compounding. Conversely, “dispensing” refers to a compounded medication provided to an individual patient pursuant to a prescription or a doctor’s order.
Congress gave the FDA the authority to place a limit on the interstate “distribution” of compounded medicines; it did not give the FDA the authority to limit the interstate “dispensing” of compounded products. That the FDA ignores this distinction and places a limit on both means that patients would not be able to get the medicines they need.
This bill doesn’t fix every misguided action of the FDA since they began their attack on compounded medicine. Patient access to bioidentical hormones like progesterone and estriol is still threatened, since they’ve been nominated to the Demonstrably Difficult to Compound list (read our recent article for the latest on this crucial issue). Still, this bill is a major first step forward in saving important natural medications from the FDA’s chopping block, and it needs our support.
Action Alert! Write to your member of Congress and tell them to support the Preserving Patient Access to Compounded Medications Act. Please send your message immediately.