“Last November, FDA Commissioner Hamburg testified, “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.’” – Sens. Harkin, Alexander
Washington, D.C., June 9 – The Chairman and Ranking Member of the U.S. Senate committee on health policy, Sens. Tom Harkin (D-Iowa) and Lamar Alexander (R-Tenn.), today urged Senate leaders to bring to the Senate floor legislation in July unanimously approved by the committee last month that would clarify oversight of drug compounders “in order to prevent further tragedies.”
Last year contaminated drugs traced to a Massachusetts compounding pharmacy caused an outbreak of fungal meningitis that has led to 745 illnesses and 58 deaths.
The senators said the Commissioner of the Food and Drug Administration had testified that if Congress fails to act “this type of incident will happen again.”
In a letter to Senate Majority Leader Harry Reid and Senate Republican Leader Mitch McConnell, Sens. Harkin and Alexander cited a new outbreak announced by the Center for Disease Control and Prevention linked to a compounded product from a pharmacy in Newbern, Tennessee. 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.’
“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.”
The Pharmaceutical Compounding Quality and Accountability Act, introduced by Harkin and Alexander with 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.
The HELP Committee’s work on legislation to improve the safety of compounded drugs came in response to the fall 2012 fungal meningitis outbreak, which was directly traced to contamination in steroid injections produced at a large-scale compounder, the Massachusetts-based New England Compounding Center (NECC).
The full text of the letter is below:
June 7, 2013
Dear Leader Reid and Minority Leader McConnell:
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. 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.
The meningitis outbreak last fall is still taking its toll on U.S. citizens. As of June 3, nationwide there were 58 deaths out of 745 total cases. Twenty states in total have been affected by the outbreak, and many patients still are struggling with recurring infections and the side effects of the anti-fungal medication.
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.”
We have evidence that both of these statements were true. Just this past week, the Center for Disease Control and Prevention announced another outbreak linked to a compounded product from a pharmacy in Tennessee. As of June 4, over 20 illnesses have been reported in Illinois, North Carolina, and Florida.
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.
Thank you for your consideration of this matter.
Sincerely,
Tom Harkin
Lamar Alexander