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Statement of Senator Tom Harkin (D-IA) at the HELP Committee Hearing: “Pharmaceutical Compounding: Proposed Legislative Solution”

*As Prepared for Delivery*

“Last November, this Committee convened a hearing to better understand what caused one of the worst public health crises this country has experienced in recent years: the meningitis outbreak that has claimed the lives of 53 Americans and sickened more than 700.  Through that hearing and the efforts of our investigation teams, we’ve developed a better understanding of the legal and regulatory gaps that allowed owners and managers at the New England Compounding Company to disregard basic procedures to ensure that the products they were manufacturing were sterile.  This gross negligence had heartbreaking consequences for families nationwide.

“Following that hearing, members of this committee initiated a bipartisan investigation involving all of our offices.  We met several times a week to identify and examine the various issues around compounding, and to conduct discussions with stakeholders with a goal of developing a draft proposal.

“Today, we have convened this hearing to look forward.   We want to talk about solutions.  As most of you know, almost two weeks ago we released a bipartisan draft proposal designed to improve the safety of compounded human and animal drugs.  Our purpose today is to gather key stakeholder input about that draft, so we can refine it as we move toward markup.

“We are grateful for the substantial input we’ve received from stakeholders at every stage in developing this draft.  You responded to our call for comments in October, participated in our hearing in November, followed up with comments reacting to the proposal FDA presented at that hearing, spent substantial time talking with us in the interim, and submitted comments on the draft we recently released.  Constructive feedback on any unintended consequences with potential solutions is exactly what I want to hear.  However, it is very troubling when I learn that some folks are ginning up vulnerable populations and saying this draft would end their ability to get lifesaving medications for their children.  That is not helpful and I will not stand for that. Instead please tell us if there are unintended consequences. We want to address them.

“Your participation in this process has been invaluable, and we look forward to learning more from the experts today – from Dr. Janet Woodcock of FDA on our first panel, and from other key stakeholders today on our second panel.    We know that some of you think that our proposal goes too far, and some think that it doesn’t go far enough.  We often say that we know we’ve hit the sweet spot if no one is completely happy.  But our purpose today is to make sure that the draft fulfills its fundamental goals. 

"In releasing that draft, we had three purposes:

  • First, we wanted to make clear the compounding oversight responsibilities of state and federal authorities.  The draft legislation 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 FDA.
  • Second, we wanted to provide FDA the tools that it needs to oversee the entities for which it will be primarily responsible.  Those tools include both authorities and resources.  The proposal gives FDA clear authority to find out who compounding manufacturers are and what drugs they are making, to set appropriate quality standards, and to carry out inspections to ensure that those standards are met.  It also gives FDA resources to help ensure that agency can actually exercise the authorities they’re given.
  • Finally, and most importantly, this draft will be judged on whether it will actually make a difference.  Will this draft prevent a tragedy like the outbreak last fall from happening again?

“As we talk to our witnesses today, I will be asking them how well the draft fulfills these purposes:  Does it clarify responsibilities?  Does it give FDA the tools it needs to fulfill the agency’s oversight responsibilities? And does it improve the safety of compounded drugs so that patients nationwide can trust the quality and safety of their medicines? 

“With what we learn today, we will modify and improve the draft as necessary, with the goal of a markup before Memorial Day.  I look forward to working with the Members of this Committee to refine our draft to better ensure the quality of compounded drugs.”