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Consumers Union Letter to Senators Harkin and Enzi on the Food and Drug Administration Safety and Innovation Act

 

April 24, 2012

The Honorable Tom Harkin
Committee on Health, Education, Labor, and Pensions
United States Senate
428 Senate Dirksen Office Building
Washington, DC 20510

 

The Honorable Michael B. Enzi
Committee on Health, Education, Labor, and Pensions
United States Senate
428 Senate Dirksen Office Building
Washington, DC 20510

 

Dear Chairman Harkin and Ranking Member Enzi:
Consumers Union recognizes the significant work both of you have done to reach the compromise language in the Manager’s Package on the Food and Drug Administration Safety and Innovation Act, (FDASIA). While we are very disappointed that it does not include numerous patient safety measures we advocate for, specifically on the safety of medical devices, it does include some important provisions that represent a step forward for consumers. In the current bill, we support:

 

  • Allowing the FDA to more easily up-classify problematic devices so that subsequent, similar devices will receive more scrutiny before they get to patients.
  • Creating a timeframe for finalizing proposed regulations on unique identifier for devices and an implementation timeline for implementing these rules. It is beyond time to get this essential component to improving the post market oversight of implantable, life-sustaining and life saving devices.  Once the UDI is in place, FDA will be better able to track problematic devices and make sure patients are warned about safety problems.
  • Codifying the requirement that approval for high-risk devices is contingent on conducting required post market studies. This should make it easier to impose civil monetary penalties on bad actors, leveling the playing field for companies that comply.
  • Placing timelines on 522 studies so that the FDA is able to react quicker when device safety issues have been identified.
  • Requires FDA to do more to reach out to non-conflicted experts and to involve more groups – including scientific societies the Institute of Medicine, and the American Academy of Medical Colleges – in its recruitment efforts.

 

We appreciate that in the face of much industry pressure, the Managers Amendment retains important disclosure provisions for financial conflicts of interest of FDA advisory panelists.  It is particularly unfortunate that the draft agreement rolls back some hard fought gains on conflict of interest curbs for advisory panelists that were enacted in 2007 as part of the Food and Drug Administration Amendments Act.

 

We are also disappointed that the final bill does not address the current problem allowing new devices to be sold based on recalled predicates or significantly strengthen FDA’s ability to provide rigorous post-market oversight.

 

We look forward to working with you to improve this important bill as its moves to the Senate for a floor vote.

 

Sincerely,

Lisa McGiffert

Manager, Consumers Union Safe Patient Project