Tuesday, June 21, 2011

Vol. 1, No. 12: How Can FDA Improve Its Financial Disclosure Rules for Clinical Investigators in this New Era of Transparency?

How Can FDA Improve Its Financial Disclosure Rules for Clinical Investigators in this New Era of Transparency?

Seth B. Whitelaw

Whitelaw discusses the changes to financial disclosure regulations following the passage of the Patient Protection and Affordable Care Act. The new transparency requirements created by the Act are out of sync with FDA’s existing regulations, and Whitelaw explains that this could lead to increasing cost for manufacturers.

The author specifically recommends that FDA should:
  • Require disclosure of payments to institutions in addition to investigators.
  • Set reportable limits based upon annual compensation received during a calendar year, establish unambiguous points for the beginning and end of a study and allow applicants to cross-reference data in disclosures made under the new PPACA sunshine provisions.
  • Enforce the disclosure provisions when breached.

This article is available for download at http://fdli.org/pubs/policyforum/ now. All issues of FDLI's Food and Drug Policy Forum are free to FDLI members and can be purchased by non-members.

If you have any difficulty posting your comment, please contact Sarah Sansolo at sks@fdli.org.

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