August 19,2005

Chairman Grassley comments on verdict of Texas jury in lawsuit involving the painkiller Vioxx


TO: Reporters and Editors
FR: Jill Kozeny, 202/224-1308
RE: Jury Verdict in Vioxx Lawsuit
DA: August 19, 2005

Sen. Chuck Grassley issued a comment today regarding verdict reached today by a Texas jury in a case involving the painkiller Vioxx.

Since early 2004, Grassley has conducted extensive oversight of the FDA and putpressure on the drug safety agency to respond in a more timely and forthcoming way when newinformation about drug risks is available. In April 2005, Sen. Grassley introduced bipartisanlegislation to set up a new drug safety office within the Food and Drug Administration andrequire drug makers to submit ads to the FDA for review in advance of ad placement. The billwould also require new disclosures in ads for higher risk or newer drugs. Sen. Grassley is alsothe lead co-sponsor of pending legislation to establish a mandatory clinical trials registry for drugmanufacturers.

Grassley comment regarding today’s jury verdict:

"The Food and Drug Administration was also negligent in the Vioxx case. Those runningthe nation's public safety agency dismissed the concerns of their own scientists and kept thepublic in the dark about emerging problems with Vioxx. Drug safety is always a balancing actbetween benefits and risks, but with Vioxx the FDA's priorities were clearly misplaced. A toocozy relationship with a drug maker put lives at risk. The American people need to know that theonly client the FDA is worried about is John Q. Public."