Last night's episode of John Oliver's Last Week Tonight on HBO included a segment on pharmacy compounding. Following is a statement about that segment by IACP Executive Vice President Scott Brunner, CAE, released this afternoon.
Sunday evening on his show Last Week Tonight, host John Oliver went on a 20-minute rant about pharmacy compounding. He strung together old and tragic news with cherry-picked examples and a couple of scornful references to the new Cats movie. It culminated in a tour-de-force sketch during which celebrities argued about a parrot - which ought to tell you something about the segment's purpose: It was for laughs.
The truth about pharmacy compounding is considerably more nuanced than what Oliver presented, of course, but Oliver is a comedian, and there's little place for nuance in his take-no-prisoners brand of comedy-parading-as-expose'.
Oliver is right to recognize that pharmacy compounders serve otherwise unmet medical needs by creating customized medications for which there does not exist an FDA-approved manufactured drug. If an acceptable FDA-approved manufactured alternative existed, there'd be no need to create a compounded medication.
For the very reason that compounders are creating medications that are not FDA-approved, quality, safety and care are paramount to compounders' success. The standards we must meet are high, and those who egregiously violate them should lose their licenses.
Oliver asserts that there are too few pharmacy inspectors at the state level, and he might be right about that. But he seems to take the very real challenges of enforcing current regulation to mean that compounding should be more highly regulated. One might ask why the response to insufficient enforcement - as was the case with the NECC tragedy Oliver cited - should be to add new regulations to enforce.
Pharmacy compounding is already among the most highly regulated health care professions. Both compounding pharmacies and patients benefit from that regulatory framework. But regulation works best when it is practical and not so onerous it impedes patient access.
That's why, since the NECC tragedy seven years ago, IACP and numerous other industry associations, distributors, and experts have met literally dozens of times with FDA officials and offered abundant informal input and formal comments on FDA proposals regarding pharmacy compounding and will continue to do so.
In last night's segment Oliver focused on a perceived lack of adequate regulation of outsourcing facilities - those that provide non-patient-specific preparations to physician clinics, for instance. Oliver skewers outsourcing facilities, but fails to note that FDA has perpetuated uncertainty in that marketplace - by failing to finalize an acceptable agreement with states on interstate shipments of compounded drugs and by onerously restricting bulk substances outsourcing facilities can use - so that it's no wonder more pharmacies haven't yet registered as outsourcing facilities.
One more thing: Oliver reeled off a list of compounding tragedies and violations going back a decade or more but failed to note the millions of patient-specific preparations compounded by accredited compounding pharmacies each year that do exactly what they're supposed to do: make or keep patients well. Far more adverse events occur from the use of off-the-shelf drugs than from compounded preparations. In his rehash of tragic events, he failed to go back to 2004, for instance, when a manufactured drug was reported to have caused 140,000 heart attacks that resulted in 60,000 deaths. And that's just one episode. In the past 24 months alone, there have been 210 drug recalls, the vast majority of which involve manufactured, FDA-approved drugs. Likewise, there are far more reports of adverse events from manufactured drugs than from compounded preparations.
The point is not to deflect attention away from concerns about pharmacy compounding, but to demonstrate that no profession or industry is trouble-free. As the voice for pharmacy compounding, IACP is working - with its members, with regulators, with suppliers, with researchers, with prescribers, and with patients - to help assure an environment in which compounding professionals adhere to the highest standards, enforcement is robust and appropriate, and patients are well cared for.
I like a good laugh as well as anyone does, and I admit I share Oliver's doubts about the new Cats movie. But the care of patients is no laughing matter - nor is the integrity and passion with which most pharmacy compounders approach their profession.
Last night, John Oliver glossed for the sake of laughs. The reality is much more nuanced. We'd welcome the opportunity to show him what compounders really do - and how millions of Americans benefit from it every day.
IACP is the voice for pharmacy compounding, representing thousands of pharmacists, technicians, students, researchers and suppliers. Compounding exists for patients and animals who are not served by traditional pharmaceutical manufacturers. Every day, IACP members play a critical, often life-or-death role in patients' lives, creating custom medications that patients simply cannot get anywhere else. They are a valued part of the health care team, creating essential medications unavailable elsewhere for a range of issues, including autism, oncology, dermatology, ophthalmology, pediatrics, women's health, and more.