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.
Close [ x ] More from GovExec

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

  • Forecasting Cloud's Future

    Conversations with Federal, State, and Local Technology Leaders on Cloud-Driven Digital Transformation

  • The Big Data Campaign Trail

    With everyone so focused on security following recent breaches at federal, state and local government and education institutions, there has been little emphasis on the need for better operations. This report breaks down some of the biggest operational challenges in IT management and provides insight into how agencies and leaders can successfully solve some of the biggest lingering government IT issues.

  • Communicating Innovation in Federal Government

    Federal Government spending on ‘obsolete technology’ continues to increase. Supporting the twin pillars of improved digital service delivery for citizens on the one hand, and the increasingly optimized and flexible working practices for federal employees on the other, are neither easy nor inexpensive tasks. This whitepaper explores how federal agencies can leverage the value of existing agency technology assets while offering IT leaders the ability to implement the kind of employee productivity, citizen service improvements and security demanded by federal oversight.

  • IT Transformation Trends: Flash Storage as a Strategic IT Asset

    MIT Technology Review: Flash Storage As a Strategic IT Asset For the first time in decades, IT leaders now consider all-flash storage as a strategic IT asset. IT has become a new operating model that enables self-service with high performance, density and resiliency. It also offers the self-service agility of the public cloud combined with the security, performance, and cost-effectiveness of a private cloud. Download this MIT Technology Review paper to learn more about how all-flash storage is transforming the data center.

  • Ongoing Efforts in Veterans Health Care Modernization

    This report discusses the current state of veterans health care


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