Meningitis Outbreak Prompts Calls for FDA to Regulate Compounders

Nov. 16, 2012— -- WASHINGTON -- Senators from both political parties said Thursday they plan to craft legislation to give the FDA authority over compounding pharmacies the agency says is needed in light of the ongoing fungal meningitis outbreak that has killed 32 people.

But what that legislation will look like and if it will even gain enough support to pass remains to be seen.

"Hopefully, we'll have something soon next year to help put this sad chapter behind us," Senate Health, Education, Labor and Pensions Committee Chair Tom Harkin (D-Iowa) said at the close of a Senate hearing examining the meningitis outbreak.

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FDA Commissioner Dr. Margaret Hamburg received more harsh questions during the hearing about why her agency didn't do more to stop the New England Compounding Center (NECC) -- known by state and federal regulators to have a shaky track record -- before it shipped more than 17,000 vials of tainted methylprednisolone acetate that has sickened 461 and killed 32 since late September.

Hamburg, as she did before a House Energy and Commerce subcommittee on Wednesday, said the FDA's authority over compounding pharmacies is "limited, unclear, and contested."

While compounding pharmacies are regulated by state boards of pharmacies, manufacturing is overseen by the FDA, and the line separating the two has been blurred by court cases rejecting the agency's actions, she said. That limited authority helped the NECC sidestep FDA oversight as a manufacturer and produce contaminated products.

Now Republicans and Democrats in the Senate say the FDA needs power over compounders that clearly mass-produce drugs in advance for bulk shipping.

"We don't need to disturb the local drugstores and we don't need to do more about the big manufacturers," Sen. Lamar Alexander (R-Tenn.) told MedPage Today on Thursday. "We need to make sure that when a hospital in Tennessee buys a steroid that it buys it from a manufacturer that is regulated by the FDA, or it buys it from a pharmacy that is properly regulated."

Hamburg reiterated her call for a tiered approach to regulating compounding pharmacies, separating them into "traditional" and "nontraditional." She made similar calls yesterday during the House hearing.

Traditional compounders, who generally operate under the one-prescription-one-drug paradigm, will still be under the oversight of state boards of pharmacies. Nontraditional compounders would register with the FDA and adhere to other requirements typically mandated for manufacturers.

The FDA's approach is far too complicated, one pharmacy trade group said.

"When we start with these tiers and these additional hybrids, I am very concerned," David Miller, RPh, chief executive of the International Academy of Compounding Pharmacists, told senators. "The more complex we make this and the more we get into the shuffle between who is accountable ... we will not resolve this problem. Either you are a pharmacy or you are a manufacturer."