“We are reviewing the proposed legislation and look forward to working with Congress and other stakeholders to strengthen FDA’s authority over compounding pharmacies…we need a clear path forward that is proactive and preventive and that takes the need for compounded products and the evolution and potential risks of pharmacy compounding into consideration,” an FDA representative told TheDC in statement.
Though DeLauro only confirmed to TheDC that she worked with Lowey on the bill, insiders believe the creation of the SAFE Compounded Drugs Act actually began in the U.S. Senate, where its goals were pushed for by Lamar Alexander and DeLauro’s longtime ally and Huffington Post co-blogger, Tom Harkin.
Alexander, who is expected to become the ranking member of the Senate Health, Education, Labor and Pensions (HELP) Committee in the next Congress, spoke at a HELP Committee hearing Nov. 15 called “Pharmacy Compounding: Implications of the 2012 Meningitis Outbreak.”
Alexander said at the hearing that he is working with HELP Chairman Sen. Tom Harkin, a liberal Iowa Democrat, on legislation “to be introduced early in the next Congress.”
“[FDA’s] job would be more like, say, the Nuclear Regulatory Commission,” Alexander said.
FDA could “certify a state agency as adequate to [regulate] sterile compounding or inadequate to do it,” according to Alexander.
“The FDA could set standards and certify the state to handle that narrow area of compounding — and be able to take it away … if FDA had the authority, it should jerk the ability of Massachusetts to deal with these sorts of entities at least until Massachusetts cleaned up its act,” Alexander said.
FDA Commissioner Margaret Hamburg said, in regard to Alexander’s plan, “that would certainly be one model that could work.”
Alexander’s close working relationship with Harkin is currently the source of speculation on Capitol Hill.
In addition to the HELP Committee, Alexander is also a top candidate to become ranking member of the Labor, Health, and Human Services Subcommittee, which Harkin chairs. That would create a “parallel leadership structure” between Alexander and Harkin across two committees.
Alexander has been planning his next power play in the Senate since stepping down as Republican conference chairman in January to focus on “creating bipartisan coalitions.”
The offices of Alexander, Harkin, and Lowey did not immediately return requests for comment.