January 12,2006

Grassley Expresses Concern Over New FDA Guidelines on Human Testing of Experimental Drugs

M E M O R A N D U M

To: Reporters and Editors
Fr: Jill Gerber for Chairman Grassley, 202/224-6522
Re: New FDA guidelines on human testing by drugmakers
Da: Thursday, Jan. 12, 2006

Today the Food and Drug Administration released relaxed guidelines for human testing by
drugmakers. The guidelines are meant to apply more modern scientific techniques and ease
manufacturing requirements to speed up testing on human subjects and therefore bring drugs to the
market faster. Sen. Chuck Grassley, chairman of the Committee on Finance, has been conducting
oversight of the FDA’s consumer protections and made the following comment on today’s
announcement.

“Of course people want to get safer, better drugs faster, but there have to be sufficient checks
and balances in the drug approval process. At a time when new questions are being raised about
whether participants in clinical trials are protected and treated ethically, the FDA is loosening the
reins on drug companies. It’s no secret that the FDA is too cozy with the drug industry, so I’m
concerned for those who will be receiving these experimental drugs. I’ll work to ensure that these
guidelines don’t compromise human safety.”