Elections Have Consequences: Fungal Meningitis and Compounding Pharmacies

In this article appearing in Scientific America, Judy Stone does an amazing job of pointing out the flaws of pointing the finger at and criticizing the FDA when it comes to compounding issues:

Let’s play pin the blame on…the FDAThere’s one thing there is no shortage of in this tragic meningitis outbreak finger-pointing. The first point of attack was, appropriately, on the pharmacy. Rather than compounding drug for an individual patient, they became a major supplier across the country. In fact, they sold large quantities of the implicated steroid product to the government itself, for the Veterans Administration. Further, while she reportedly recused herself, Sophia Pasedis was an executive for a NECC-affiliate as well as board member and former president of the Massachusetts Board of Registration in Pharmacy. This obviously raises the question as to whether a cozy relationship might have led to averted gazes.
But, as in keeping with tradition, the main question has been, “Why doesn’t the FDA regulate compounding pharmacies?” The answers are quite peculiar. First, the FDA actually doesn’t appear to have the authority to do so, according to Kevin Outterson, director of the health law program at Boston University. As collateral damage in a 2002 suit, (Thompson vs. Western States Medical Center), in a Supreme Court ruling regarding a pharmaceutical company’s advertising and free speech, the FDA lost much of its regulatory oversight of compounding pharmacies.
While the FDA is being criticized for not providing more oversight, according to Regulatory Focus, “In a case involving Franck’s Pharmacy—the same company whose products were involved in the May 2012 recall—a judge ruled FDA could “not assume it had authority to regulate compounding pharmacies.” Professor Outterson further details how the 2002 Supreme Court ruling hobbled the FDA in a recent New England Journal of Medicine article, concluding, “It’s possible that if the Supreme Court hadn’t struck down Section 503A, the tragedy at NECC could have been averted.”
So now the FDA has to wait until there is a problem before they can intervene in production by a compounding pharmacy. According to the NY Times, theInternational Academy of Compounding Pharmacists actually “tutored pharmacists on how to sidestep requests” for information or samples from inspectors.
Adverse reactions are not easy to detect. This outbreak was picked up early because of an astute Infectious Diseases physician at Vanderbilt, Dr. April Pettitt, who took a careful history, prompting her suspicion that her patient’s unusual fungal meningitis was related to the injections he had received.
There is no well-organized procedure for detecting adverse outcomes. Side effects are reported during clinical trials, but include relatively small numbers of patients. Post-marketing or for compounded drugs, there is only a voluntary reporting system through MedWatch. Frankly, many physicians either don’t think of this, nor will they find it very gratifying activity to complete yet more forms. And while the number of FDA analysts has held steady, the number of adverse event reports has steadily grown, along with the number of drugs available. Even when there are drug recalls, detecting lots is cumbersome and not everyone adheres to the recalls.
The FDA is in an unenviable position. While they were aware of some problems at NECC and, in fact, issued a warning in 2006, the FDA has deferred to “states’ rights”: “so long as a pharmacy’s operations fall within the scope of the practice of pharmacy (as outlined in FDA’s Compliance Policy Guide 460.200), FDA will generally continue to defer to state authorities for regulatory oversight.”
Once again, the FDA is in a no-win position. If they try to be tough enforcers, they are damned by pro-business forces, like Congressman Darrell Issa’s witchhunt report, the FDA’s Contribution to the Drug Shortage Crisis, where he criticizes the FDA warnings to manufacturers about production problems before actual outbreaks occurred, as being unnecessary. Would Issa have preferred the FDA to wait for outbreaks? Then the FDA would have been damned for not being proactive enough, which is what the consumer watchdog group, Public Citizen, has just done.

Read this entire article here