Aug. 4 (Bloomberg) -- The U.S. Food and Drug Administration won't include outside specialists on its advisory panels if they have a personal financial stake of more than $50,000 in a company affected by a matter under discussion, the agency said.

The FDA may allow a specialist with a lesser financial interest to participate if there is ``an essential need for the adviser's particular expertise,'' the agency said today in a statement.

The FDA has been under criticism from lawmakers and consumer groups for allowing doctors and scientists with ties to drug and medical-device makers to vote on recommendations about products from those companies. The FDA proposed the new limits last year, and today's announcement makes final similar restrictions.

``It's imperative that we seek advice from independent experts, and that we do so in a way that is public, open, and transparent,'' said Randall Lutter, the deputy commissioner for policy, in the statement.

As a result of legislation approved last year, the FDA is limiting the number of waivers it issues, allowing those with financial conflicts to participate in meetings. A conflict can involve a stake in a company with a product before the FDA or in one of its competitors.

Committee members are paid to meet several times a year to recommend approval, rejection or further research on medical products. The FDA usually follows the advice of its advisers, though it isn't required to do so.

48 Meetings

The agency convened 48 meetings of advisory committees last year on topics from the safety of diabetes medications to the evaluation of cancer drugs for children, according to the FDA's statement.

The draft plan proposed last year said that advisers with conflicts of $50,000 or less could get waivers to participate in meeting discussions and not cast votes. The final policy allows members with waivers to vote.

``It's a huge difference,'' said Sidney Wolfe, director of Public Citizen's Health Research Group, a Washington-based advocacy organization, in a telephone interview. ``Financial conflict of interest taints decision-making and voting. To move off of one of the elements that was more likely to reduce it, I just don't think is a good idea.''

The FDA made that change partly in response to public comments, said Jill Hartzler Warner, senior policy advisory and counselor at the agency.

`Stringent Standard'

The new rules ``really go beyond the legal requirements and provide quite a stringent standard for our advisory committees,'' Warner said in a telephone interview.

In ``limited cases'' the FDA commissioner can personally waive the restrictions and allow advisers with conflicts of more than $50,000 to serve on panels, according to the policy.

Representative Maurice Hinchey, a New York Democrat who has repeatedly criticized the FDA over conflicts among advisers, praised the new policy and said the agency should go further.

``This country is filled with an extraordinary number of brilliant minds, and there is no reason the FDA can't fill its advisory panels with experts who have no financial conflicts of interest whatsoever,'' Hinchey said in an e-mailed statement.

The Pharmaceutical Research and Manufacturers of America supports the FDA's ``efforts to address potential concerns about the appearance of conflicts of interest,'' said Ken Johnson, senior vice president of the Washington-based trade group, in a statement.

The FDA also issued final guidelines today saying that panel members should vote on recommendations simultaneously, instead of sequentially, to avoid members' being swayed by the votes of others. Panels generally have been following that practice.

Also today, the agency proposed that first-of-a-kind products for human use be referred to an advisory panel, or that the agency be required to summarize why it didn't do so, the FDA said.

To contact the reporter on this story: Justin Blum in Washington at jblum4@bloomberg.net.

Last Updated: August 4, 2008 17:20 EDT