http://www.medscape.com/viewarticle/541453?src=mp
US FDA Moves to Clarify Advisory Panel Rules
WASHINGTON (Reuters) Jul 24 - Industry ties to doctors and other health
experts who serve on U.S. Food and Drug Administration advisory panels would
be disclosed in more detail under guidelines the agency is developing.
FDA Deputy Commissioner Scott Gottlieb said on Monday the draft guidelines
would also provide more information about which conflicts are eligible for
an agency waiver allowing panelists to participate.
The advisory committees, composed mostly of doctors and researchers who
offer opinions on whether drugs and devices should be approved, have come
under scrutiny in recent years over some panelists' ties to manufacturers.
"We want to be more transparent, and specific, about these reasons, to the
maximum extent possible, so people can better understand the relationships
that we accommodate and our reasons for doing so," Gottlieb said in prepared
remarks for a discussion on government advisory panels later on Monday.
The agency released the remarks ahead of the event, sponsored by the
advocacy group Center for Science in the Public Interest (CSPI).
Twenty-three FDA advisory committees meet throughout the year to evaluate
drugs and biologics, while another 21 evaluate devices. A handful of other
panels weigh food, animal products and other areas. The FDA is not required
to follow advisory panel recommendations but it usually does.
Potential conflicts of interest can range from stockholdings and research
grants to speaker and consultant fees.
Some critics, including editors of leading medical journals, argue that at
the very least such ties give an appearance of a conflict and require
doctors to disclose links when publishing articles. CSPI says no ties are
acceptable.
Others say it is common practice for researchers to receive funding from
industry, and many doctors have argued that it does not affect their
judgments or practice of medicine.
"It is simply the case that top experts are going to sometimes have these
kinds of relationships. In some cases... we want these experts on our
committees precisely because they have this experience," Gottlieb said in
his remarks.
Congress has gotten involved, last year requiring the FDA to publish which
panelists have received a waiver 15 days before a committee meets.
In May, the U.S. House of Representatives passed a measure banning any
scientist with financial links to drug or device companies from serving on
the FDA's committees.
CSPI's Merrill Goozner, who heads the group's Integrity in Science Project,
said the FDA was wrong to argue that only researchers who work for industry
have expertise.
"There are people out there who conduct clinical trials... but they do it on
somebody else's nickel," he told Reuters. Those experts are harder to find,
he added, but it can be done. It just takes a little while longer."
Reuters Health Information 2006.
Regards,
Catherine
.