NAP Consultation: Consumer and Medical Transparency

OpenTheGovernment.org posts summaries of meetings on the Open Government Partnership National Action Plan between civil society members and the administration. Summaries from the first National Action Plan can be found at OpenGovPartners.org/US

 

Participants:

Corinna Zarek, National Archives and Records Adminstration

Robbie Barbero, Office of Science and Technology Policy

Sarah Fenn, White House Counsel’s Office

Gavin Baker, Center for Effective Government

Diana Zuckerman, National Research Center for Women & Families

Paul Brown, Cancer Prevention and Treatment Fund

Bill Vaughan, National Committee to Preserve Social Security and Medicare

Susan Harley, Public Citizen

 

Participants discussed possible expansions and additions to the White House commitment to “improve transparency of consumer-product-safety information, using collaborative social media, crowdsourcing, and analytics tools to create a real-time dashboard showing performance and safety issues for certain consumer products,” particularly regarding medical devices and drugs.

It is still not clear what aspects of the dashboard will be public facing. Part of the dashboard may be a tool to help companies understand and track the approval process. This initiative originated at the FDA, but the agency was not represented at this meeting.

Suggested improvements for transparency included:

  • Ensure the summaries of evidence provided to the FDA by companies are available to the public.
  • Improve the accuracy of ClinicalTrials.gov—many of the registered trials did not have results posted on the site. Post-market studies are also rarely made available to the public.
  • Provide to the public materials prepared for Advisory Panel Meetings in a timely and easily accessible manner, even for the panel meetings that do not end up occurring.
  • Improve user-friendliness in access to consumer information. Specifically, information about recalls, if posted, is posted in different places and in different formats. The Center for Effective Government recently posted an analysis of the Recalls.gov website. The FDA’s site upgrade also made information more difficult to find.

The CSOs in attendance will work with their community and larger network to develop a more comprehensive list of recommendations for White House commitments to greater transparency in this area. Government representatives asked for CSO members to specifically identify what they’d like to see for specific agencies, including the FDA, EPA, and USDA. 

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