The pharmacy compounding profession is vital for patients who cannot use a commercially manufactured medication because they need a special strength, are allergic to an inactive ingredient or can’t get access to a drug. Yet lately, compounding has been treated like the stepchild of the health care system, skewered for laughs on late-night TV or attacked by those with a vested financial interest in seeing the profession eliminated.
There is no doubt that compounding has had its challenges, including, in 2012, the actions of the New England Compounding Center, which shamefully disguised a manufacturing operation as a compounding pharmacy, leading to more than 60 fatalities and hundreds of patients falling ill with fungal meningitis. It would be easy to look at NECC and conclude that the profession is unsafe and unethical. A closer and more balanced examination, however, proves that traditional compounding is anything but.
Any industry can have bad actors, and when it is a caregiving industry, the stakes are always high. Commercial drug manufacturers have their share of notorious failings, as well, from price gouging bad boy Martin Shkreli to manufactured drugs found to be unsafe after patients were harmed. Regulators have blocked drugs from a pharmaceutical manufacturer for glass shards found in medications and have hit health systems with major fines for violating patient privacy.
Yet the overwhelming majority of compounding pharmacies are run by well-trained, caring practitioners who provide critical support to patients with very specific needs. They serve millions of patients across America. They pride themselves on patient safety and compliance and view regulation and enforcement as a good thing for their profession. They want robust standards that are fairly enforced.
These practitioners, who are educated and licensed in the science of pharmacy and drug compounding, know that the solution to quality concerns is not creating more regulation; rather, it is ensuring that there is consistent and uniform enforcement of the regulations that are already on the books. Had that been the case some seven years ago, there would have been no NECC tragedy.
Congress passed the Drug Quality and Security Act, signed into law by President Barack Obama in November 2013, in part to ensure a better regulatory framework for pharmacy compounding. The Food and Drug Administration’s implementation, however, has varied substantially from what was intended by Congress. The FDA is now proposing to go far beyond what Congress directed.
The DQSA created two categories of compounding pharmacy: those that create patient-specific medications and are regulated by state boards of pharmacy; and drug “outsourcing facilities” that prepare medications for hospitals, clinics and physicians and adhere to stringent manufacturing standards. The latter group is overseen by the FDA following voluntary registration.
The DQSA’s two-tier system, while not the solution that either the industry or the FDA wanted back in 2013 — seems to make good common sense. Yet, in its proposal to fully implement the new system, the FDA has overreached, conflating the distinction between patient-specific dispensing at traditional pharmacies with the bulk distributions generated by outsourcing facilities. This would give the FDA oversight of the practice of traditional compounding in a manner that Congress never intended, thereby stripping vast responsibilities from state boards of pharmacy.
All of this would be implemented under a memorandum of understanding between the FDA and each state, which the agency said it will finalize before year-end. So far, many states have indicated they cannot sign the MoU as proposed, citing the incursion of the FDA into what has traditionally been state-level regulation.
In states that refuse to sign the MoU, traditional compounders will be limited to shipping no more than 5 percent of the medications they compound to patients out of state — even those medications for which the patient has a valid prescription. We believe the result will be to severely limit patient access to compounded medications while usurping state regulatory authority.
There is a middle way, and the FDA should embrace it. It’s a proposal submitted by a handful of national pharmacy associations that would address states’ concerns about signing the MoU while also ensuring that patient-specific dispensing is not “distribution.”
There are no compounding pharmacists who have designs on building giant drug factories. They simply seek to meet the needs of prescribers and patients who rely upon a custom medication when there is no manufactured drug to meet the need. Often, those needs can transcend state borders.
It’s a mistake to think that tragedies like NECC represent pharmacy compounding and the thousands of professionals who serve their patients with integrity and care. Compounders are not a threat to the public’s well-being — they are a driver of it.
The FDA should create regulation that is fair and consistent, hews to what Congress passed, and recognizes and values the roles that compounders play in America’s health.
Michael Blaire is a member of the Arizona State Board of Pharmacy and is vice president for government and regulatory affairs at Wedgewood Pharmacy in Scottsdale, Ariz.
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