Regulatory morass

Lawmakers work to clarify policies for compounders

Federal lawmakers, government health officials and health-system pharmacists want clearer policies to determine who should regulate the large-scale compounding pharmacies such as the one blamed for a deadly fungal meningitis outbreak that has left 33 dead.

That was the focus of two congressional hearings last week, where Food and Drug Administration Commissioner Dr. Margaret Hamburg found herself in the hot seat, fielding questions from lawmakers demanding more information about what the agency should have done to prevent the outbreak that also sickened 480 people, according to federal figures updated Nov. 16.

The infections emerged in September, and officials linked the outbreak to contaminated, compounded methylprednisolone acetate, an injectable steroid distributed by the New England Compounding Center, a Framingham, Mass.-based compounding pharmacy.

Sen. Tom Harkin (D-Iowa), chairman of the Senate Health, Education, Labor and Pensions Committee, opened his panel's hearing by asking how 17,000 doses of a product so contaminated that black particles were visible to the naked eye after recall could have been shipped to 23 states. Harkin noted that the FDA and the Massachusetts Board of Registration in Pharmacy repeatedly found deficiencies in several areas at NECC and yet neither the Massachusetts board nor the FDA took action to protect the public.

Meanwhile, lawmakers were unsuccessful at gleaning information from Barry Cadden, co-owner and director of pharmacy at NECC. He exercised his Fifth Amendment right against self-incrimination several times during a hearing of the House Energy and Commerce Oversight and Investigations Subcommittee. A day later, the Senate panel dropped him from its witness list.

Throughout the hearings, witnesses and lawmakers concentrated on the uncertainty related to which regulatory body has authority over compounding pharmacies with large-scale operations. States oversee pharmacies, while the FDA has oversight over manufacturers.

“I think a lot of practitioners believe that when an entity says they're registered with the FDA, that they're subject to GMPs (good manufacturing practices) the same way, that they're inspected and regulated in the same way as a brand name or generic manufacturer is,” Kasey Thompson, vice president in the office of policy, planning and communications at the American Society of Health-System Pharmacists, said after the Senate hearing. “What we're learning is, that's not the case. And that's very problematic.”

Thompson said there should be a third category—something in between a compounding pharmacy and a manufacturer. His association presented lawmakers with a series of recommendations, including one that state boards of pharmacy continue to license and regulate traditional compounding while more large-scale compounding of sterile products be subjected to FDA oversight.

That model is similar to the risk-based framework that Hamburg unveiled to lawmakers in both chambers last week. “The fact that we have unclear, limited and contested authorities and ambiguities in the law and a crazy quilt of legal authority has required us to be very reactive responding to those serious public health threats,” Hamburg said in the House hearing.

Hamburg's suggested framework calls for two categories of compounding: traditional compounding, which includes the combining, mixing and altering of ingredients to customize medication for a patient; and nontraditional compounding, which poses higher risks. Nontraditional compounding would be subject to federal standards that could be enforced either by the FDA or a state willing to oversee compounding

activities that the FDA deems nontraditional. That category, Hamburg suggested, could include sterile compounding; products shipped across state lines; and drugs mixed before there is a prescription or order for a particular patient, sometimes called “anticipatory compounding.”

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Rep. Henry Waxman (D-Calif.) urged his colleagues to pass legislation in this congressional term that would resolve the ambiguities surrounding the FDA's authority over compounding pharmacies. But Reps. Cliff Stearns (R-Fla.) and Michael Burgess (R-Texas), a physician, said lawmakers need more information from the FDA to determine if the agency already has the proper authority to oversee operators such as NECC, a compounding pharmacy that some believe acted as a drug manufacturer.

And even if the FDA does have such authority, the question then becomes whether the agency is adequately prepared to carry out the job, said Glenn Engelmann, senior counsel and vice chair of the life sciences industry at the law firm McDermott Will & Emery.

“Those operations clearly need to be subjected to tighter oversight,” he said. “It makes sense for FDA to do it. If they feel they need more statutory authority, if there's a need for more clarity, that's fine. But I think it's important they address the resource issue, or something's going to give.”



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