Iowa Senator Chuck Grassley is testifying before a U-S House panel this morning on drug safety issues at the U.S. Food and Drug Administration. Grassley is appearing before the House Energy and Commerce Subcommittee on Oversight and Investigations. He says he’s been studying the F.D.A.’s actions for years and believes public safety is at stake.
Grassley says on Monday, the F.D.A."very dramatically scaled back its approval of a relatively new antibiotic called Ketek and put its strongest warning on the label. The Food and Drug Administration did this after nearly a year, nearly a year of public concern of the flawed process by which the Food and Drug Administration approved this very drug in the first place."
Under the new guidelines, Ketek is to no longer be used to treat sinusitis and bronchitis as theF.D.A.says it may be "too risky." It will still be used for treating pneumonia, but it will carry much stronger warnings. Grassley applauds the about-face by the F.D.A..
Grassley says "Yesterday’s actions by the Food and Drug Administration show what transparency can do to achieve accountability and at the same time give credibility to the process of congressional oversight being very worthwhile." Reports say U.S. doctors have written some six-million prescriptions for Ketek since it was put on the market in 2004 and Grassley says it’s unknown how many lives may’ve been endangered by the controversial medication.
Grassley says "I’m going to keep the pressure on the Food and Drug Administration to overhaul this agency culture which I documented to be too cozy with the drug companies and not forthcoming when its very own scientists find new risks about drugs on the market."
In addition to Grassley’s testimony, other witnesses are expected to include former F.D.A.employees who’ve blown the whistle on serious problems in the agency’s drug review policies. Grassley says there are reports the F.D.A. withheld evidence about Ketek from an advisory committee that was assigned to review the drug.