Following yesterday's troubling review of Sanofi-Aventis' antibiotic Ketek in The Wall Street Journal, a number of Congressmen have launched calls for an investigation into its approval. Some, like Representative Henry A. Waxman, say the FDA's action highlights the need for reform at the agency. The Journal reported that a number of patients taking the drug have died and raised a number of questions about Aventis' last drug trial.
"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," said Rep. Edward Markey. "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."
- read this release [1] for Washington's reaction
Links:
[1] http://www.medadnews.com/News/index.cfm?articleid=336623