The heads of FDA and the Massachusetts Department of Public Health (MDPH) (MDPH) both support legislation proposed by Rep. Ed Markey (D-MA) to strengthen regulatory oversight of compounding pharmacies, according to their testimony at today’s investigative hearing conducted by the House Energy & Commerce Subcommittee on Oversight and Investigations.
FDA Commissioner Margaret A. Hamburg, MD, and MDPH Interim Commissioner Lauren Smith, MD, MPH, indicated that they supported Markey’s bill during the 4-hour hearing, The Fungal Meningitis Outbreak: Could It Have Been Prevented? Markey introduced his bill, the Verifying Authority and Legality in Drug (VALID) Compounding Act (H.R. 6584), on November 2. His congressional district was home to the now-closed New England Compounding Center (NECC) linked to the deadly outbreak.
The emotional hearing took place on Congress’s first day back in session after the elections. While there was consensus in the room on the magnitude of the tragedy, opinion on what went wrong from a regulatory standpoint and what to do moving forward appeared to be somewhat split along party lines. And while both sides of the dais pointed fingers at FDA, the intensity of the grilling of Hamburg also appeared to vary along party lines.
Yet all the emotion was not just for show. Joyce Lovelace, whose husband died as a result of the outbreak, spoke about the “nightmare” being lived by her family and begged the Members of Congress before her to “do something.” Barry Cadden, the President, Co-Owner, and Director of Pharmacy of NECC, who was subpoenaed to appear, repeatedly invoked the Fifth Amendment when it was his turn to speak.
And so attention turned to the regulating agencies, represented by Hamburg and Smith, and to the question of whether a fix to federal law—namely the Food, Drug, and Cosmetic Act, and in particular section 503A—was necessary. Hamburg noted that section 503A of the 1997 law exempted pharmacies from FDA jurisdiction, and described a “changing, evolving industry overlaid on top of a fragmented and ambiguous legal framework” caused by patchwork of regulatory authority and two court cases limiting that authority in different parts of the country. She called for a “seamless system” that clarified state and federal regulatory authority.
Democrats such as Henry Waxman (D-CA) wanted to push “to correct the law … before we leave at the end of this year” for fear that “interest groups are going to gear up to stop this.” But Republicans such as Phil Gingrey (R-GA) appeared reluctant to change existing law, expressing concern about “over-reacting and over-regulating compounding pharmacies.” Gingrey noted that he would be very surprised if there weren’t “multiple lawsuits” and “folks serving jail time,” but that NECC was “an absolute crooked operation” and should not be confused with traditional compounding pharmacists.
Pharmacy representation can be expected at tomorrow’s hearing by the full Senate Committee on Health, Education, Labor, and Pensions, Pharmacy Compounding: Implications of the 2012 Meningitis Outbreak, when two pharmacy groups are scheduled to speak: the International Academy of Compounding Pharmacy and American Society of Health-System Pharmacy.
And while Cliff Stearns (R-FL), Chairman of the subcommittee, said that legislation may not happen during the lame-duck session, Diana DeGette (D-CO), ranking Democrat on the subcommittee, said that “we have a job to clarify the law if there’s not clarity in the law, and we can easily do it.”
“The whole area is just rife with ambiguity,” Markey said in the last words allotted to the Democrats. “And in that atmosphere of ambiguity, we’ve wound up with a mess on our hands. And we just have to make sure that never happens again.”