US FDA Moves to Clarify Advisory Panel Rules

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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 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. "

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