WASHINGTON, D.C.– Representative Edward J. Markey (D-MA) and Representative Henry A. Waxman (D-CA), senior Democrats on the House Energy and Commerce Committee, sent a letter today to the Food and Drug Administration (FDA) questioning actions surrounding its approval of the antibiotic telithromycin (Ketek).  Ketek is an antibiotic that is approved for treatment of certain bacterial lung and sinus infections in people 18 years and older. Although the FDA has consistently assured the public of Ketek’s safety and efficacy, public documents obtained and examined by Reps. Markey and Waxman’s staff indicate that the approval process for this drug was seriously flawed.

Rep. Markey said, “I am very concerned that the FDA approved Ketek even though it may be neither safe nor effective, and that FDA has allowed the sponsor to give this drug to children in clinical trials. We need to look more closely at the Ketek case to determine whether this approval was made in error, and we need to assess whether the Ketek approval process reflects broader systemic problems within the FDA.  We cannot allow this critical public health watch dog agency to become a lapdog for the pharmaceutical industry.”

“The Ketek case demonstrates the urgent need for reform at the FDA and in the pharmaceutical industry,” said Rep. Waxman.   “We know drug companies manipulate published studies on their drugs, hiding negative information from physicians.  Here, Aventis went even further, failing to disclose to FDA grave flaws in a key safety study. FDA approved the drug on flimsy data without resolving the safety issues, and it failed to penalize Aventis.  Americans deserve more vigilance from FDA and from the companies that make critical medical treatments.”

The Markey-Waxman letter sent to the FDA, which requests numerous documents and responses to questions about the FDA approval process for Ketek as well as other drugs, states, “We are concerned that the facts and circumstances surrounding Ketek’s approval by the FDA may be indicative of broader systemic problems at the FDA which, if left unaddressed, could result in physicians unknowingly prescribing unsafe and/or ineffective medications to Americans... The public has a right to know how the FDA reached its decision to approve Ketek and whether they can rely on those conclusions.”

Rep. Markey said, “Recently the GAO found that the FDA does not have a good enough system in place to protect the public from drugs once they are on the market. However, the Ketek case shows that the FDA may also not be doing a good enough job deciding which drugs should or should not be approved in the first place.”

For more a copy of the letter or information on Rep. Markey’s work on the safety of drugs on the market, clinical trials, post-marketing studies and FDA oversight, please visit www.house.gov/markey.

Copy of Letter to Acting FDA Committioner (5/1/06) Copy of Letter to Acting FDA Committioner (5/1/06) (439.50 KB)
Copy of Letter to Acting FDA Commissioner Appendix A (5/1/06) Copy of Letter to Acting FDA Commissioner Appendix A (5/1/06) (403.75 KB)
Copy of Letter to Acting FDA Commissioner Appendix B (5/1/06) Copy of Letter to Acting FDA Commissioner Appendix B (5/1/06) (71.27 KB)

May 1, 2006


CONTACT: Tara McGuinness
Kate Reinhalter (Markey)

Karen Lightfoot (Waxman)