Clearer policies and definitions are needed to address the uncertainty surrounding which regulatory body has jurisdiction over large-scale operations that compound medications, experts testified Thursday as the Senate took its turn examining the fungal meningitis outbreak that has left 32 dead.
Sen. Tom Harkin (D-Iowa), chairman of the Senate Health, Education, Labor and Pensions Committee, opened the panel's hearing by asking how 17,000 doses of a product so contaminated that black particles were visible to the naked eye upon recall could have been sent to 23 states. That product—an injectable steroid known as methylprednisolone acetate, or MPA—has been linked to NECC, a Framingham, Mass.-based compounding pharmacy company. Harkin also added that despite an “abundance of documentation,” neither the Massachusetts Board of Pharmacy nor the Food and Drug Administration appeared to have taken action to protect the public.
Similar to Wednesday's House hearing, FDA Commissioner Dr. Margaret Hamburg and Dr. Lauren Smith, interim commissioner at the Massachusetts Department of Public Health, testified about the actions of state and regulatory agencies since the outbreak. Meanwhile, Harkin said the panel did not subpoena Barry Cadden, the co-owner, president and director of pharmacy at NECC, as the House lawmakers did. And because Cadden continually took the Fifth Amendment in Wednesday's House hearing, there was “no need to go through that charade,” Harkin said, explaining Cadden's absence at the hearing.
As lawmakers sought clarity on whether the FDA or the states have regulatory jurisdiction over pharmacy compounding companies, Hamburg outlined her agency's proposal for a risk-based framework in which traditional compounding would remain under state purview, while “nontraditional compounding”—which she said poses higher risks—would be subject to federal standards.
Hamburg's testimony laid out what might fall under nontraditional compounding, including the type of product or activity, such as sterile compounding; the amount of product that is being made; and whether the drug is being shipped between states.
That model is similar to the one proposed by panel witness Kasey Thompson, vice president of policy, planning and communications for the American Society of Health-System Pharmacists. Thompson said as lawmakers consider legislative policies, state boards of pharmacy should license and regulate traditional compounding, while large-scale compunding of sterile products may require oversight from the FDA. Thompson's association did not collaborate with the FDA on its proposals, he said after the hearing.
David Miller, executive vice president and CEO of the International Academy of Compounding Pharmacy in Missouri, Texas, testified that to distinguish between a pharmacy and a manufacturer, it's important to look at what function the entity is performing, rather than its size.
“It's relatively simple,” Miller said. “Are they filling a prescription, or filling bulk quantities, and are they being sold as opposed to being dispensed?”
An aide for the Senate HELP committee said the panel's staff will discuss what lawmakers learned in the hearing on Friday and then determine next steps.
Separately Thursday, a group of House Democrats requested the Government Accountability Office examine whether contracting policies by hospital group purchasing organizaitons are a cause of drug shortages that lead hospitals and physicians to rely on compounding pharmacies.
“In the drug shortage crisis of recent years, doctors and hospitals were increasingly forced to turn to compounding pharmacies like the one that caused the devastating meningitis outbreak,” Rep. DeGette (D-Colo.) said in the letter to the GAO (PDF)
. “While we've begun to address drug shortages legislatively, it is clear we must aggressively investigate the factors that led to this deadly outbreak and determine possible remedies, so we can take steps to save patients' lives.”