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Markey Calls FDA Warning for Ketek Long Overdue, Plans to Introduce Bill to Improve FDA Approval Process and Drug Safetly

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Location: Washington, DC


MARKEY CALLS FDA WARNING FOR KETEK LONG OVERDUE, PLANS TO INTRODUCE BILL TO IMPROVE FDA APPROVAL PROCESS AND DRUG SAFETY

Rep. Edward J. Markey (D-MA), a senior member of the House Energy and Commerce Committee, which has jurisdiction over the Food and Drug Administration (FDA), called the FDA's warning on the prescription drug, Ketek, long overdue and plans to reintroduce legislation this week to increase transparency and accountability at FDA.

Rep. Markey said, "It is good for families that the FDA has finally acknowledged the safety risks of Ketek and put a black box warning—the strongest warning available—on the drug's label. The FDA has moved so slowly to protect Americans from dangerous side effects of Ketek that I am gravely concerned about its ability to protect the public health from other drugs it has or will approval."

"The timing of the FDA's move, on the day before the House Energy and Commerce Committee begins public hearings into the FDA's actions on Ketek is no coincidence. It appears that a healthy dose of Congressional oversight has reminded them to do their job and ensure the safety of drugs on the market," Markey continued.

Working with FDA whistleblowers, Rep. Markey will introduce a bill this week, the Swift Approval, Full Evaluation (SAFE) Drug Act that likely will:

- Provide enhanced whistleblower protections to FDA employees.
- Preserve scientific integrity at FDA by prohibiting FDA employees from directing other FDA employees to censor or suppress scientific research, analysis, opinions or recommendations or directing employees to disseminate scientific information that is known to be false or misleading.
- Will require the FDA to provide Advisory Committees with complete information.
- Ensure Scientific Freedom at FDA, by guaranteeing FDA and FDA-sponsored authors the right to publish or present their work.
- Increase FDA transparency, by requiring a biennial report to Congress on non-inferiority studies and a biannual report to Congress on postmarket studies system.
- Increase FDA authority with respect to postmarket studies.
- Provide FDA greater authority with respect to Accelerated Approval, by ensuring postmarket study plans are reviewed prior to approval; requiring proper labeling until drugs are fully approved; and restricts advertising for accelerated approved drugs or biologics until full approval.

Rep. Markey has been working with FDA whistleblowers and investigating the FDA's inaction on the safety problems with Ketek for almost a year. On May 1, 2006, Rep. Markey and Rep. Waxman sent a letter to the FDA requesting information regarding the safety and efficacy of Ketek. The FDA still has not responded to their inquiry.

Rep. Markey has been working with FDA whistleblowers and investigating the FDA's inaction on the safety problems with Ketek for almost a year. On May 1, 2006, Rep. Markey and Rep. Waxman sent a letter to the FDA requesting information regarding the safety and efficacy of Ketek. The FDA still has not responded to their inquiry.

http://markey.house.gov/index.php?option=com_content&task=view&id=2600&Itemid=141

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