August 02,2005

Grassley reacts to PhRMA announcement on direct-to-consumer advertising, drug safety

M E M O R A N D U M

TO: Reporters and Editors
FR: Jill Kozeny, 202/224-1308
RE: PhRMA announcement on direct-to-consumer advertising
DA: August 2, 2005

Sen. Chuck Grassley today issued a statement about the pharmaceutical industry’s newly unveiled guiding principles on direct-to-consumer advertising.

In April, Sen. Grassley introduced legislation with Sen. Dodd to set up a new drug safety office within the Food and Drug Administration and require drug makers to submit ads to the FDA for review in advance of ad placement. Their legislation would also require new disclosures in ads for higher risk or newer drugs. The legislation is pending in the Senate.

Since 2004, Grassley has conducted extensive oversight of the FDA and put pressure onthe drug safety agency to respond in a more timely and forthcoming way when new informationabout drug risks is available. In addition to the post-market review legislation, Sens. Grassleyand Dodd introduced a bill to establish a mandatory clinical trials registry for drugmanufacturers.

Here is a comment from Sen. Grassley about the announcement made today by thepharmaceutical industry.

“This announcement acknowledges the need for greater transparency when it comes todrug safety, but it doesn’t deliver a single guarantee for consumers. The Food and DrugAdministration needs to stop dragging its feet and start exercising its authority to closely monitorthe marketing of pharmaceuticals. In addition to a dramatically stepped up effort by the FDA, weneed an updated law that requires drug makers to submit their ads to the FDA for review. Itdoesn’t make sense to rely on drug companies to police themselves.”