FDA wants to act as your physician and regulate your access to customized medications. Action Alert!
With its new guidance, the FDA is further tightening the screws on pharmacies that produce customized medications for individual patients. The agency is inserting itself into the role of “doctor” by deciding for patients whether there is a “clinical need” for certain medicines to be made at pharmacies. The reason? We believe they want to protect the monopoly of FDA-approved drugs.
In its latest guidance, the FDA is signaling that it will further restrict the medicines that can be made at outsourcing pharmacies by adopting a stringent definition of “clinical need” if there is already an FDA-approved drug for a given condition. This is important for sensitive patient populations, such as autistic children who need their drugs allergen free or in a liquid, as opposed to pill, form. For example, an FDA-approved drug may contain peanut oil, so it would be inappropriate for patients with peanut allergies, and thus there should be a clinical need to compound that substance in a modified form, without the peanut oil. But if an FDA-sanctioned clinical need cannot be demonstrated according to their new criteria, the variation needed for patients with peanut allergies won’t make it to the preapproved list, and thus won’t be available for those who need it.
The very idea that the FDA has the expertise to decide every patient’s “clinical need” is ludicrous—these are decisions that should be left up to doctors and their patients. It also undermines consumer choice—if a patient prefers an alternative dosage form out of comfort or convenience, that should be enough, even if there isn’t necessarily an FDA-approved “clinical need.”
This guidance, and the FDA’s entire treatment of customized natural medicines to this point, demonstrate to us that patients and consumers are not the agency’s top priority—rather, it’s protecting Big Pharma’s monopoly over medicine. The guidance admits as much. It says, “compounding a drug product from a bulk drug substance that is a component of an FDA approved drug when there is no clinical need to do so…undermines the drug approval process (emphasis added).”
Since the passage of the Drug Quality and Security Act (DQSA) in 2013, ANH-USA has been closely following the FDA’s implementation of the law—which, by and large, has been a non-stop assault against compounding pharmacies—pharmacies that produce customized medicines for individual patients, such as intravenous vitamin drips and bioidentical hormones, including estriol. We’ve been concerned mostly with “traditional” (503A) pharmacies, but DQSA created a second category called “outsourcing” (503B) pharmacies. Outsourcing pharmacies are generally larger manufacturing facilities and will only make medicines that appear on a pre-approved list by the FDA.
We need to send a message to the FDA that patients will stand up to these attacks against customized medicines.
Action Alert! Write to the FDA and tell them that the bar set for “clinical need” in the new guidance will undercut patient health and consumer choice. Please send your message immediately.