If you want to see what a world without regulatory safeguards looks like, you don’t have to look far. The current and evolving outbreak of fungal meningitis tied to one large compounding pharmacy in Massachusetts is a case study in what happens when state and federal regulators fail. It also shows what can happen when conflicts of interest get in the way of regulation based on the best available science.
The outbreak of fungal meningitis cost more than 30 lives and harmed more than 400 individuals. Photo: Flickr User Zaldylmg
The company, New England Compounding Center (NECC), had been cited for serious safety and procedural violations for more than a decade. Food and Drug Administration (FDA) officials threatened various enforcement actions but didn’t follow through, despite serious warning signs of risk to the public. State regulators, who had the primary responsibility to oversee NECC, also were extremely lax. NECC made and distributed tainted injectable products for back and neck pain used to treat more than 14,000 patients, killing more than 30 and harming more than 400.
This is what happens in part when industries evolve and regulators don’t catch up.
Unlike a neighborhood pharmacy, where pharmacists prepare medications based on individual prescriptions for patients with special needs, compounding pharmacies now often serve hospitals or nursing homes and produce products in high volume, sometimes without individual prescriptions, and distribute their products across the country.
In 1997, Congress made its first attempt to address federal regulation of compounding pharmacies, but the law was challenged in court. Rulings by the Supreme Court and lower courts gave the FDA limited and confused authority, making its enforcement actions more vulnerable to litigation, and more difficult for the agency to identify bad actors and get pertinent records.
It’s clear that compounding pharmacies like the one in New England responsible for the outbreak of fungal meningitis need stricter oversight. Photo: Flickr User Genista
In 2007 Congress tried to reign in compounding pharmacies. But a Senate bill, advanced by Senators Edward Kennedy (D-MA), Richard Burr (R-NC) and Pat Roberts (R-KS), ran into major industry opposition, and died.
In the meantime, the primary responsibility for regulating NECC fell on the Massachusetts Board of Registration in Pharmacy. The Board, which included at least two conflicted members, did a terrible job overseeing NECC as it piled up scores of safety and procedural violations.
Board member Sophia Pasedis oversaw regulatory compliance for NECC’s sister company, Ameridose, now also in serious trouble with regulators. Pasedis claims that whenever NECC was discussed, she recused herself. But there is no definitive proof, such as evidence in the minutes, that she did for all meetings.
We don’t know whether Pasedis influenced the eleven-member Board to loosen its oversight. But the fact that she was able to serve on the board, and even as the board’s president for a time, seems to be a symptom of a board more sympathetic to business interests than the public interest.
Another board member got into trouble with the state ethics commission for trying to solicit a pharmacy company under the board’s review to do business with one of his clients. We don’t know if there were other conflicts of interest because board members, almost all of whom are pharmacists, are not required to annually disclose their financial interests.
Congressman Ed Markey (D-MA) has proposed legislation to give the FDA more authority over compounding pharmacies. Photo: Congressman Ed Markey’s website
Conflicts on boards of pharmacy are not unusual. In 2008, USA Today reported that many employees of chain pharmacies serve on pharmacy boards across the country, and that these members sometimes voted on disciplinary and other matters that affected their employers as well.
But as the practice of pharmacy changes, those conflicts and other problems of oversight become more urgent. Both the House and Senate recently held hearings on the current meningitis outbreak and how to prevent such abuses in the future. It’s clear that we need a system where compounding pharmacies must register with the FDA, so the agency knows how many operate and where they are located, and so that they can pay registration fees to support more oversight. The FDA must have the authority to ask for any records from such businesses, and to require them to report any adverse events from their products to the agency.
Given the reality of an FDA with limited staff and resources and a huge safety mandate, Sen. Lamar Alexander’s (R-TN) suggestions make sense. He has proposed a system that would have the FDA setting the standards for regulating compounding pharmacies and then delegating that authority for oversight to state boards of pharmacy that meet those standards.
Senator Lamar Alexander (R-TN) has suggested a common-sense reform to change the way we regulate compounding pharmacies. Photo: Senator Lamar Alexander’s website.
But if state boards are to work effectively with the FDA, Congress must give the agency the authority to impose standards on how such boards operate. Any state board that wishes to have primary oversight of large compounding pharmacies should be required by the FDA to responsibly address conflicted members, including identifying conflicts when they occur and how they were handled. Boards should be required to make efforts to recruit members without financial ties to pharmacies, seeking out professors of pharmacology, retired pharmacists, nurses, physicians, and public health advocates, and to disclose members’ backgrounds. To ensure transparency, the FDA should require state boards to hold open meetings and post transcripts or webcasts on their websites, and to fully disclose information about their enforcement actions.
California’s Board of Pharmacy shows that boards can operate transparently, include several public members, and ensure a diversity of experts.
All this transparency and focus on conflicts of interest won’t turn state boards into models of regulatory efficiency, nor will they guarantee that either the FDA or the states will be as vigilant as they should be. But these reforms will send a strong message that such standards matter. Further, they will enable the public and journalists to look over the shoulders of the regulators, and to ensure that they are fulfilling their missions.