Panel may issue subpoenas related to FDA drug approval

The House Energy and Commerce Oversight and Investigations Subcommittee will vote Tuesday on subpoenaing Food and Drug Administration criminal investigators and documents related to a potentially deadly drug the FDA approved despite receiving fabricated data, according to a subcommittee memo obtained by CongressDaily.

The subpoenas may be part of the panel's investigation into whether pharmaceutical company Sanofi-aventis knew of critical integrity problems in clinical trial data it submitted to FDA on the antibiotic Ketek. Sanofi-aventis's lead researcher on the largest Ketek clinical trial, Anne Kirkman-Campbell, pleaded guilty to mail fraud in 2004 in connection with accusations she enrolled weight-loss patients and others in the trial who did not suffer from the respiratory illnesses Ketek treats.

The panel might subpoena FDA investigators Robert West and Douglas Loveland and former investigator Robert Ekey as well as Ann Marie Cisneros, who was a contractor who oversaw the Kirkman-Campbell study and said she reported problems to Sanofi-aventis to no avail, according to the subcommittee memo sent Friday. The subcommittee also is after a document that is expected to reveal investigators recommended that Sanofi-aventis deserved prosecution, not just Kirkman-Campbell, for knowingly submitting false trial data. FDA handed over the note to the subcommittee but redacted the entire document.

Senate Finance ranking member Charles Grassley, R-Iowa, who first looked into Ketek as chairman of the committee, and Energy and Commerce Committee leaders have questioned whether FDA conspired to approve Ketek despite knowing about the false trial results. FDA has maintained it largely excluded Kirkman-Campbell's study data and relied mostly on European data.

The subcommittee also wants FDA Commissioner Andrew von Eschenbach's briefing book from a March 22 subcommittee hearing where he was accused of making false statements regarding Ketek's approval. Lawmakers want to know whether the commissioner was deliberately misled in preparation for the hearing. They have tried requesting the briefing documents, but HHS has denied the request. FDA approved Ketek in 2004 and just a year ago pulled approval of the drug for two of the more minor illnesses it treated, chronic bronchitis and acute bacterial sinusitis.

FDA agreed with its expert advisory panel that determined in December 2006 that Ketek had not proved beneficial to treat the respiratory illnesses in light of its risk. Ketek remains approved to treat pneumonia. In addition to the Ketek subpoenas, the subcommittee also will vote whether to subpoena documents related to its investigations into generous bonuses FDA distributed, particularly $5,000 bonuses given to its civilian physician employees.

Stay up-to-date with federal news alerts and analysis — Sign up for GovExec's email newsletters.
FROM OUR SPONSORS
JOIN THE DISCUSSION
Close [ x ] More from GovExec
 
 

Thank you for subscribing to newsletters from GovExec.com.
We think these reports might interest you:

  • Sponsored by Brocade

    Best of 2016 Federal Forum eBook

    Earlier this summer, Federal and tech industry leaders convened to talk security, machine learning, network modernization, DevOps, and much more at the 2016 Federal Forum. This eBook includes a useful summary highlighting the best content shared at the 2016 Federal Forum to help agencies modernize their network infrastructure.

    Download
  • Sponsored by CDW-G

    GBC Flash Poll Series: Merger & Acquisitions

    Download this GBC Flash Poll to learn more about federal perspectives on the impact of industry consolidation.

    Download
  • Sponsored by One Identity

    One Nation Under Guard: Securing User Identities Across State and Local Government

    In 2016, the government can expect even more sophisticated threats on the horizon, making it all the more imperative that agencies enforce proper identity and access management (IAM) practices. In order to better measure the current state of IAM at the state and local level, Government Business Council (GBC) conducted an in-depth research study of state and local employees.

    Download
  • Sponsored by Aquilent

    The Next Federal Evolution of Cloud

    This GBC report explains the evolution of cloud computing in federal government, and provides an outlook for the future of the cloud in government IT.

    Download
  • Sponsored by Aquilent

    A DevOps Roadmap for the Federal Government

    This GBC Report discusses how DevOps is steadily gaining traction among some of government's leading IT developers and agencies.

    Download
  • Sponsored by LTC Partners, administrators of the Federal Long Term Care Insurance Program

    Approaching the Brink of Federal Retirement

    Approximately 10,000 baby boomers are reaching retirement age per day, and a growing number of federal employees are preparing themselves for the next chapter of their lives. Learn how to tackle the challenges that today's workforce faces in laying the groundwork for a smooth and secure retirement.

    Download
  • Sponsored by Hewlett Packard Enterprise

    Cyber Defense 101: Arming the Next Generation of Government Employees

    Read this issue brief to learn about the sector's most potent challenges in the new cyber landscape and how government organizations are building a robust, threat-aware infrastructure

    Download
  • Sponsored by Aquilent

    GBC Issue Brief: Cultivating Digital Services in the Federal Landscape

    Read this GBC issue brief to learn more about the current state of digital services in the government, and how key players are pushing enhancements towards a user-centric approach.

    Download
  • Sponsored by CDW-G

    Joint Enterprise Licensing Agreements

    Read this eBook to learn how defense agencies can achieve savings and efficiencies with an Enterprise Software Agreement.

    Download
  • Sponsored by Cloudera

    Government Forum Content Library

    Get all the essential resources needed for effective technology strategies in the federal landscape.

    Download

When you download a report, your information may be shared with the underwriters of that document.