The lead Republican on the U.S. Senate health committee today called for the full Senate to vote “as soon as possible” on legislation unanimously approved by the health committee in May to clarify oversight of drug compounders, as Centers for Disease Control and Prevention reports the number of deaths caused by a multistate outbreak of fungal meningitis has risen to 61.
Contaminated drugs traced last year to a Massachusetts compounding pharmacy led to the outbreak that has led to 749 illnesses and 61 deaths, the CDC reported Monday.
Senator Lamar Alexander said: “Americans continue to lose loved ones from the meningitis outbreak, and the Commissioner of the Food and Drug Administration has warned us that this will happen again if Congress fails to act. The health committee worked on and the unanimously passed a bill to help prevent such a crisis from happening again, and the legislation should be called up for a vote as soon as possible.”
The Pharmaceutical Compounding Quality and Accountability Act, introduced by Senator Alexander with committee Chairman Tom Harkin (D-Iowa) and Sens. Pat Roberts (R-KS) and Al Franken (D-MN), makes a clear distinction between traditional compounding—which will continue to be regulated primarily by state pharmacy boards—and compounding manufacturers that make sterile products without, or in advance of, a prescription and sell those products across state lines. The compounding manufacturers would be regulated by the U.S. Food and Drug Administration (FDA). It clarifies a national, uniform set of rules for compounding manufacturers while preserving the states’ primary role in traditional pharmacy regulation.
In a June letter to Senate Majority Leader Harry Reid and Senate Republican Leader Mitch McConnell, Sens. Alexander and Harkin cited a new outbreak announced by the CDC linked to a compounded product from a pharmacy in Newbern, Tenn. As of June 4, more than 20 illnesses have been reported in Illinois, North Carolina, and Florida that may have been caused by contaminated drugs from this pharmacy.
They wrote: “Dr. Janet Woodcock, the Director for the Center of Drug Evaluation and Research, has testified in front of our committee that, ‘If, in fact, action is not taken, this will happen again. It's not a question of whether. It's a question of when.’ Last November, FDA Commissioner Hamburg stated, ‘We have a collective opportunity and responsibility to help prevent further tragedies. If we fail to act, this type of incident will happen again. It is a matter of when, not if, I'm afraid. If we fail to act now, it will only be a matter of time until we're all back in this room asking why more people have died and what could have been done to prevent it.’
The senators continued: “On May 22, 2013, the Committee on Health, Education, Labor and Pensions (HELP) approved S.959, the Pharmaceutical Quality and Accountability Act by voice vote. S. 959 clarifies who is responsible for compounding manufacturers that compound sterile products without a prescription and ship them across state lines. Compounding manufacturers will have to register and be inspected by FDA, while traditional pharmacy continues to be regulated by the states. We have worked with pharmacists, physicians, patients, consumer groups, state boards, and the FDA for over 6 months to craft this bipartisan legislation. It provides the necessary clarity and accountability to ensure the proper oversight of all compounded drugs. The HELP Committee worked rapidly on a bipartisan basis to respond to this crisis and we expect to be able to report out this unanimous piece of legislation in the next few weeks for consideration by the full Senate.”
The senators wrote: “We are writing to urge you to bring this legislation before the full Senate in July. The legislation will ensure that there is no confusion about who is responsible for keeping America’s drugs safe, whether compounded or manufactured.”