Senators pledge regulation of compounding pharmacies

Nov 17 2012

At a Capitol Hill hearing, senators from both parties promised to take action following a meningitis outbreak that killed 32 people.

Politico: Senators Grill FDA Commissioner On Outbreak
Food and Drug Administration Commissioner Margaret Hamburg acknowledged Thursday that the FDA could have acted more decisively against the company implicated in the meningitis outbreak but asked lawmakers to clarify and strengthen the agency's powers to regulate compounding pharmacies. Given more than a decade of documented safety and other violations at the New England Compounding Center, "I wish that [FDA's] responses had been more timely … that they had been better coordinated with the states," Hamburg said at a hearing of the Senate Health, Education, Labor and Pensions Committee (Norman, 11/16).

The Associated Press/Washington Post: Senate Health Chairman Promises New Drug Compounding Laws In Wake Of Meningitis Outbreak
The chairman of the Senate's health committee pledged Thursday to move ahead with legislation to tighten oversight of compounding pharmacies, amid a deadly outbreak caused by tainted specialty medications. But a top lobbyist for the compounding industry, and some fellow senators, argued that existing state and federal laws could have prevented the wave of fungal meningitis that has killed 32 people (11/15).

Reuters: U.S. Lawmakers Pledge Action After Meningitis Outbreak
Democratic and Republican lawmakers said on Thursday they would alter the regulation of drug compounding pharmacies in hopes of preventing more crises like the rare fungal meningitis outbreak that has now cost 32 lives. ... "Our first order of business (is) to answer these questions: not just whose job was it to prevent this tragedy, but whose job will it be to make sure it doesn't happen again," said Republican Senator Lamar Alexander of Tennessee, the state that has become the outbreak's epicenter with 83 cases and 13 deaths. Alexander suggested the FDA could be given powers to certify individual states as the primary regulators of large-scale compounders and withdraw certification from those that fall short. ... "In the face of such a tragedy, it is natural to want to take action. And we will," said Senator Tom Harkin, the Iowa Democrat who chairs the Senate committee (Morgan, 11/15).

The Wall Street Journal: Regulators Faulted For 'Inertia' Over Meningitis Concerns
A congressional report on Thursday released details of how federal and state regulators knew nearly a decade ago of serious safety concerns with the pharmacy tied to hundreds of meningitis cases, but failed to act decisively. Bipartisan staff of the Senate Health, Education, Labor and Pensions Committee concluded in a report that "bureaucratic inertia appears to be what allowed a bad actor to repeatedly risk public health" (Burton, 11/15).

Medpage Today: Senators Want FDA To Regulate Compounders
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 (Pittman, 11/15).

Modern Healthcare: Experts Urge Clearer Policies On Compounding Pharmacies
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 within a state (Zigmond, 11/15).

States themselves are acting to strengthen rules on these pharmacies as well --

The Boston Globe: States Try To Strengthen Rules On Drug Compounders
State pharmacy regulators across the country are moving to strengthen their oversight of compounding pharmacies like the one in Framingham that has been blamed for a deadly outbreak of fungal meningitis in 19 states. The Massachusetts pharmacy board, whose failure to ensure safe practices at New England Compounding Center was highlighted in two days of legislative hearings this week, has enacted emergency regulations and begun surprise inspections (Wallack, 11/16).