Compounding, Again
The election is over, cabinet re-shuffling has begun, and hopefully you properly prepared and stored your food and avoided poisoning family and friends over the Thanksgiving holiday. As you can imagine, food preparation at a food and drug law firm is a very serious business. We regularly swap favorite turkey brining and stuffing recipes and remind each other about safe thawing practices. I personally recommend America’s Test Kitchen’s vodka pie crust and the Pioneer Woman’s butternut squash puree.
Moving from foods to drugs, we continue to follow the ongoing investigation into the New England Compounding Company (NECC). As my partner, Jon Weinrieb, wrote, FDA Commissioner Margaret Hamburg testified on November 14 and 15 before the House Energy and Commerce Subcommittee on Oversight and Investigations and the Senate Committee on Health, Education, Labor and Pensions. The FDA has been seeking to define the line between the traditional practice of pharmacy (in theory regulated by State Boards of Pharmacy) and drug manufacturing (which FDA should regulate). Today, the FDA announced plans for a public meeting on the matter. It will also accept comments to explore these issues.
The public meeting will take place on December 19 and will be webcast. The notice states that onsite registration begins at 2 p.m. on December 19 on a first-come, first-served basis and that the meeting will be from 3 to 5 p.m. I’ve covered lots of FDA public meetings over the years (the ones in the wireless dead zone of the NHTSA hearing room below L’Enfant Plaza were especially memorable), and I’ve never seen one lasting only 2 hours. Fortunately, FDA is also accepting public comments until January 18, 2013.
Echoing some of Commissioner Hamburg’s earlier remarks, the agency is focusing upon defining “traditional pharmacy compounding that should be primarily overseen by the States and higher risk non-traditional pharmacy compounding that would require compliance with Federal standards. . . . In recognition of the States’ role, the FDA has also reached out to its State partners by inviting representatives from all 50 States to an intergovernmental meeting.” The two-hour public meeting will follow the State intergovernmental meeting.
The agency seeks comment on three questions:
- Given existing authorities and resources, are the States currently able to provide the needed oversight of pharmacy compounding and consumer protection?
- What should the Federal role be in regulating higher risk pharmacy compounding such as compounding high-volumes of drugs for interstate distribution? Is there a way to re-balance Federal and State participation in the regulation of pharmacy compounding that would better protect the public health? What strategies should be developed to further strengthen Federal/State communications?
- Do you see a role for the States in enforcing a Federal standard for “non-traditional” compounding? If so, what role? What factors would affect a decision by your State to take on such responsibility?
Given the breadth and complexity of these questions and the short, 2-hour time frame, any thoughtful response should be submitted in written comments. We’ll be watching the public meeting and live-tweeting i
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