New legislation is needed in the wake of the fungal meningitis outbreak, the International Academy of Compounding Pharmacy (IACP) and the American Society of Health-System Pharmacists (ASHP) told members of the Senate Health, Education, Labor, & Pensions (HELP) Committee at a hearing today.
Sen. Tom Harkin (D-IA), HELP Committee Chairman, pledged before adjourning the hearing that the committee “will forge ahead in developing legislation” and expected that “we’ll have something soon next year that we’ll be able to move ahead on and put this sad chapter behind us.”
Today’s 3-hour full committee hearing, Pharmacy Compounding: Implications of the 2012 Meningitis Outbreak, was a less ferocious affair than its Republican-controlled House counterpart yesterday, a 4-hour investigative hearing by the House Energy & Commerce Subcommittee on Oversight and Investigations.
The lists of witnesses at the two hearings were somewhat different. Both the House and Senate sides heard testimony from the heads of FDA and the Massachusetts Department of Public Health, and no testimony from Barry Cadden, of the New England Compounding Center (NECC) facility linked to the tragedy. (The Senate didn’t bother to subpoena him.)
But while the House heard from the family member of a victim, the Senate instead picked additional witnesses from public health organizations including CDC and the Tennessee Department of Health, and pharmacy groups including IACP and ASHP.
“The tragedy of the New England Compounding Center is quite simple to us as an organization,” IACP Executive Vice President and CEO David G. Miller, BSPharm, said in his opening statement. “They were a pharmacy that is essentially hiding behind that license, and in reality acting as an illegal drug manufacturer. Plain and simple, what NECC did was violate the trust that every member of the public has specifically in their local pharmacy [and] tainted the reputation of pharmacists throughout the country.”
Miller blamed the Massachusetts state board of pharmacy and FDA, and questioned why physicians and hospitals had purchased medications from NECC instead of from a local, accredited, compounding pharmacy.
Harkin asked Miller for the features that distinguished NECC from a legitimate large-scale compounding pharmacy, in addition to volume, interstate shipment, and prescription records.
“I am a pharmacist,” Miller answered. “I tend to think black and white. … The difference between NECC and a compounding pharmacy was that they weren’t filling prescriptions; they were bulk manufacturing and selling.” Miller said that any inspector of pharmacies could determine the difference based on the pharmacy’s paperwork.
Sen. Pat Roberts (R-KS) referred to the question of industry pushback, and asked Miller to speak to whether organized pharmacy would work with Congress.
“As a pharmacist and as an organization representing pharmacists, the worst possible thing has happened,” Miller said, citing deaths and illnesses. “Right now, the focus must be on working collaboratively. ... You have my commitment on that.”
Kasey K. Thompson, PharmD, Vice President, Office of Policy, Planning, and Communications, ASHP, noted that the distinction between compounding and manufacturing “appears to be a regulatory gray area” with obvious implications. Thompson said ASHP had developed policy recommendations, that there may be a need for a special category regulated by FDA, and that FDA must be provided with the resources it needs.
The question of sufficient resources was a theme of the hearing from Harkin, who also serves on the Senate Appropriations Committee; Sen. Barbara A. Mikulski (D-MD), who hoped that this hearing was the first in a series of hearings on not only regulatory reform, but also resource need and workforce need; and other Members of Congress.