Senator Grassley's Comment About the FDA Label and Indication Changes for the Antibiotic Ketek
Senator Grassley's Comment About the FDA Label and Indication Changes for the Antibiotic Ketek
Sen. Chuck Grassley issued this comment regarding the announcement today by the Food and Drug Administration of label and indication changes for the antibiotic Ketek:
"The FDA's action today shows what transparency can do. When a spotlight was turned on the questionable way in which Ketek got approved by the FDA for certain sinus and lung infections, the FDA was held accountable. Last summer, the warnings on the drug label got stronger, and in December, the FDA sought expert advice from its advisory committees. Now the uses for Ketek are limited, and the public is safer and better informed . My goal through legislative reform and continued oversight is to make the FDA right its wrongs without delay, and to let the science prevail, whether it's for or against
drug approval."
Sen. Grassley is scheduled to testify tomorrow before the House Energy and Commerce Subcommittee on Oversight and Investigations regarding drug safety. During the last year, Sen. Grassley has conducted extensive oversight of the way the Food and Drug Administration approved Ketek, even issuing a congressional subpoena for documents and directly confronting
officials at the Department of Health and Human Services. Documents describing his oversight and findings follow this memo.
Sen. Grassley began his oversight of the FDA three years ago. He has put pressure on the drug safety agency to act with more independence and transparency than it now demonstrates in order to restore public confidence and strengthen public safety. He has called the FDA's relationship with the drug industry "too cozy" and criticized the way that agency leaders have
acted to suppress scientific dissent regarding agency actions and drug-safety recommendations.
Last month, Sen. Grassley reintroduced his reform legislation with Sen. Chris Dodd to revamp and prioritize the post-market surveillance process within the Food and Drug Administration (S.468) and to greatly expand public access to information about clinical trials regardless of the outcome of those trials through a clinical trials registry and results database (S.467). The senators authored nearly identical bills in the last Congress in the aftermath of the Vioxx and revelation of suicide risks with the pediatric use of antidepressants.
http://finance.senate.gov/sitepages/grassley.htm