(Washington, D.C.) – Tomorrow, several clients of the Government Accountability Project (GAP) will testify at a House of Representatives hearing focusing on drug safety and the Food and Drug Administration’s (FDA) lapses in protecting the public. The Subcommittee on Oversight and Investigations, under the Energy and Commerce Committee, will hold the hearing entitled “The Adequacy of FDA to Assure the Safety of the Drug Supply” at 9:15 a.m. at 2123 Rayburn House Office Building.
Mark Cohen, GAP Food and Drug Safety Director, is the lawyer representing the GAP clients testifying tomorrow. Noting that FDA issued a press release today, one day before the hearing, announcing action on Ketek, Cohen observed: “FDA has consistently treated Ketek more as a PR problem for the Agency than as a safety concern. Thankfully, Congress is finally looking into Ketek and FDA management’s cynical approach to product safety more generally.”
The first panel the subcommittee will hear from tomorrow will consist solely of Sen. Charles Grassley (R-Ia), a whistleblower champion who has long been critical of the FDA’s structure and bureaucracy.
The second panel will focus on how FDA enabled Ketek, an antibiotic associated with nine deaths and serious liver failure in at least 23 patients, to enter the marketplace. These panelists include: Dr. David Ross, the primary safety reviewer and safety team leader for Ketek at FDA; Dr. John Powers, former Lead Medical Officer for Antimicrobial Development and Resistance Initiatives at FDA; and Ann Maries Cisneros, a senior clinical research associate involved in monitoring the fraud-laden Ketek clinical trial.
The final panel is made up of Dr. Steven E. Nissen and Dr. David Graham, Associate Director for Science and Medicine in FDA’s Office of Surveillance and Epidemiology. In 2004 Graham blew the whistle before the Senate on the FDA-approved arthritis drug Vioxx which he believes is responsible for up to 60,000 American deaths and caused another 80,000 non-fatal heart attacks.
Last December, an FDA joint advisory committee held a two-day hearing to analyze safety and efficacy issues surrounding Ketek, at which GAP clients and Cohen spoke about the history of fraudulent clinical trials, the drug’s demonstrable safety dangers, and the lack of proof that the drug even works. That advisory committee overwhelmingly recommended withdrawing the Agency’s approval for two of three indications – sinusitis and bronchitis – and placing a strict black-box warning on Ketek’s label for the third indication, community-acquired pneumonia.
Please direct media concerns to GAP Communications Director Dylan Blaylock at 202.408.0034 ext. 137 or 202.236.3733 (cell).
Contact: Dylan Blaylock, Communications Director
Phone: 202.408.0034 ext. 137, cell 202.236.3733
Email: [email protected]