Bipartisan legislation improves
accountability, enhances safety monitoring
WASHINGTON—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 study results had been available to
medical researchers and the public in one central location when they were first
available, 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 at 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.
