September 21,2007

Grassley: FDA Reform Bill Takes Important Steps, Misses Mark on Independent Drug Safety Office

Last night, the Senate gave final approval to legislation giving the Food and Drug Administration new authority to better protect patients from harm caused by drugs such as the painkiller Vioxx. The legislation is expected to be signed into law by President Bush. Sen. Chuck Grassley, ranking member of the Finance Committee, is a long-time proponent of legislation to beef up the FDA’s efforts to strengthen drug safety enforcement. Grassley made the following comment on the passage of the FDA legislation.

“This is a positive step toward restoring public trust in the FDA. When Vioxx was pulled from the market in 2004, we learned that it took almost two years of negotiations with the drug maker to add information about heart attack risks to the Vioxx label. Now FDA will have additional tools in its toolbox to better protect the American people. But I’m disappointed that Congress didn’t fix a fundamental problem at the FDA that’s been shown through my investigations over the last three years. The imbalance between the office responsible for monitoring the safety of drugs after approval and the office that puts drugs on the market in the first place has resulted in delayed agency action and even inaction on serious post-marketing safety matters. I remain committed to restoring public confidence in the FDA, ensuring that the FDA has sufficient resources to do its job, and most importantly, strengthening public safety by ensuring that the drug safety office has an equal voice.”