Consumers groups laud Dodd/Grassley bill mandating
public disclosure of drug study results
Bipartisan legislation improves accountability, enhances safety monitoring
FOR IMMEDIATE RELEASE
Monday, Feb. 28, 2005
Contact:
Susan Herold, CU, 202-462-6262
Travis Plunkett, CFA, 202-387-6121
Lindsey Johnson, USPIRG, 202-546-9707
(Washington, D.C.) — Consumer groups hailed the introduction today of bipartisan legislation that, for the first time ever, would mandate public disclosure of results from all new clinical drug trials. By making trial results public, drug companies no longer could downplay or hide results that may indicate safety problems with their products.
“This is a strong first step toward full public disclosure of all drug trial results, both good and bad,” said Janell Mayo Duncan, legislative and regulatory counsel for Consumers Union, publisher of Consumer Reports magazine. “Right now, drug companies can hide negative results from the public while promoting favorable findings, leaving doctors and patients in the dark about potentially harmful side effects.”
The Fair Access to Clinical Trials Act (FACT Act), introduced today by Senators Chris Dodd (D-CT) and Charles Grassley (R-IA), creates a public clinical drug trial results database to which drug makers are required to submit summary results and safety findings from all new clinical drug trials. Under current law, drug makers are required to provide all of their study results for approved drugs to the Food and Drug Administration, but the agency is not required to make them public and rarely does.
The bill’s introduction comes at time when FDA is under scrutiny for its failure to act on results it had from drug trials and other study results that called into question the safety of two types of widely used drugs — antidepressants and COX-2 inhibitors. Consumer groups have criticized the agency for failing to take timely action to inform the public about the risks.
“FDA had disturbing data for years, but did little about it,” said Travis Plunkett, legislative director for Consumer Federation of America. “If those results had been available to medical researchers and the public in one central location when the studies were completed, public pressure would likely have forced FDA to act sooner.”
“Congress needs to restore public confidence in the safety of prescription drugs,” said Lindsey Johnson, consumer advocate with the U.S. Public Interest Research Group. “A mandatory drug trial registry, and the creation of a strong and independent office of drug safety, will do much to restore that confidence.”
The groups said they looked forward to working with the bill’s sponsors to include in the FACT Act a requirement that drug makers also submit results and safety findings from all past clinical trials for approved drugs.