FDA Moves to Try to Reduce Conflicts of Interest on Boards

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FDA Moves to Try to Reduce Conflicts of Interest on Boards

By Shankar Vedantam

Washington Post Staff Writer

Thursday, March 22, 2007; Page A12

http://www.washingtonpost.com/wp-

dyn/content/article/2007/03/21/AR2007032102068.html

The Food and Drug Administration said yesterday that it plans to

make extensive changes in how it selects medical experts to serve on

its advisory panels after years of complaints that many of them have

financial ties to the companies whose products they evaluate.

The proposal would eliminate many experts who serve on the panels

despite having such financial conflicts, FDA officials said. Experts

with limited conflicts of interest would be allowed to participate

in the discussions but not to vote on the recommendations made to

the agency.

The advisory committees play a central role in regulating drugs,

medical devices and diagnostic tests. Their decisions largely

determine what drugs and medical products can be marketed to

Americans -- because the agency nearly always follows the panels'

guidance.

In recent years, concern about the composition of the panels has

reached a crescendo. The FDA and others have argued that overly

strict rules might eliminate many -- in some cases all -- of the

panel candidates with the needed expertise.

Yesterday, officials maintained that the agency's procedures have

not been biased in favor of industry, but the new guidelines

implicitly acknowledge what critics have long said -- that it is

possible to find enough qualified experts who do not have ties to

drug and device manufacturers.

The new rules come as Congress has become increasingly vocal about

its displeasure with how the FDA is run and follow a stinging

federal Institute of Medicine report last year, which called on the

agency to address the concerns over conflicts of interest.

" This is one of several announcements the FDA has made in recent

months whose timing suggests they are reactions both to the IOM

report and the bills moving through Congress, " said R. Alta Charo, a

University of Wisconsin bioethicist who served on the institute's

FDA review panel.

" The FDA is intent on getting out ahead of some of its critics as

effectively as possible -- and that is a good thing, " she said.

Although the changes have not gone as far as urged -- capping the

number of members with conflicts on any given panel -- Charo

said: " The last thing I want to do is discourage incremental

progress. "

Under the new rules, any scientist or physician who has had $50,000

or more in financial ties to a company over the past 12 months,

including stock or consulting arrangements, would be barred from

panels evaluating that company's products. Those who have received

less than $50,000 in the previous year might be allowed to

participate in the discussion but could not vote.

In general, the FDA said, it will try to limit the participation of

experts who are perceived to have a conflict of interest. If the FDA

commissioner thinks an expert with financial conflicts is needed on

a given panel, an exception can be made, but this will be rare, said

Randall Lutter, the agency's acting deputy commissioner for policy.

Lutter and Jill Hartzler Warner, senior policy adviser and counselor

in the FDA's Office of Policy and Planning, said it is not possible

to say precisely how many experts who currently serve on advisory

panels would be affected by the new rule, but they said it would

have a significant impact. Agency officials did calculations to

measure the impact of various cutoff points before deciding on

$50,000.

" We are very interested in ensuring we have the best possible access

to scientific experts, " Lutter said. " At the same time, we seek to

ensure we have the fullest public confidence in the integrity of our

advisory committee process. "

Lutter denied that the proposal, which will be open for public

comment for 60 days, reflects FDA unease about the panels. Rather,

he said, the step was being taken to ensure that the public's

perception about the advisory panels' quality is in line with the

agency's perception.

" We think we have done a very good job of ensuring the process

deserves the respect of the American public, " he said. " We are not

aware of any instances where decisions have been unfairly or

adversely affected by conflicts. "

Lutter and Warner said the $50,000 figure would not apply to

research grants made by pharmaceutical companies to universities

where the scientists work, only to grants given directly to experts.

Zuckerman, president of the advocacy group National Research

Center for Women & Families, said the FDA guidelines will not do

enough. Companies wield influence, she said, with sums far smaller

than $50,000.

" A drug rep who takes someone to a memorable restaurant twice a year

to chat about their research is spending relatively little money but

is building a relationship that is likely to be more influential

than giving a $2,000 honorarium -- perhaps even more than a $50,000

grant for a study funded by several companies, " she said.

Zuckerman's center analyzed the votes of 11 FDA advisory committees

from 1998 through 2005. She said the idea that experts with

conflicts could serve on committees but not vote was not well

thought out -- because nonvoting members play a substantial role in

pushing the committees in one direction or another.

" Our study of advisory committee deliberations showed the collegial,

consensus-building nature of these decisions, " she said. " The votes

are often unanimous because the group comes to a consensus, almost

always to approve a product. "