X hits on this document

72 views

0 shares

0 downloads

0 comments

24 / 35

The 2008 Barton Report further concentrated FDA’s attention on GCPs

  • In February 2008, responding the Ketek case, Rep. Joe Barton’s (R-TX) staff issued a report citing the “weakness in FDA’s ability and authority to carry out its duties and to protect its own integrity”

  • The report stressed the agency’s failure to adequately pursue disqualification and debarment of clinical investigators

  • The report also focused on the agency’s lack of authority to debar brand name drug companies for misconduct related to clinical trials

  • The Barton report concluded with the following recommendations:

    • Congress should consider extending debarment provisions enacted in the Generic Drug Enforcement Act to name-brand companies

    • Congress should consider whether a company’s misconduct that occurs after a drug product is approved should be a basis for debarment

© 2009 Hogan & Hartson LLP. All rights reserved.

24

Document info
Document views72
Page views71
Page last viewedSun Dec 04 06:22:41 UTC 2016
Pages35
Paragraphs407
Words3160

Comments