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FDA is criticised for hinting it may loosen conflict of interest rules

BMJ 2011; 343 doi: http://dx.doi.org/10.1136/bmj.d5070 (Published 08 August 2011) Cite this as: BMJ 2011;343:d5070
  1. Jeanne Lenzer
  1. 1New York

The US Food and Drug Administration has come under fire for suggesting that it may loosen conflict of interest rules for its advisers, because of a shortage of experts without ties to the drug and medical devices industry.

The FDA’s commissioner, Margaret Hamburg, said that strict rules on conflict of interest implemented in 2008, which limit the proportion of advisory panellists with industry ties to 13%, may be slowing down approvals of products and hindering innovation.

Dr Hamburg told journalists at a meeting held by the non-profit watchdog Public Citizen in Washington, DC, on 25 July that the agency had to be sure it had “subject-matter experts” “for our important decision making,” reported the online news service Bloomberg News (http://bloom.bg/r2QbrF).

Republican legislators on the House of Representatives’ Energy and Commerce Committee have been urging the FDA to loosen its rules on conflicts of interest. Bloomberg News reported Congressman Fred Upton, chairman of the committee, as saying that the rules were slowing new product approvals because advisory committees lacked enough qualified members.

The independent watchdog Project on Government Oversight, which is based in Washington, DC, wrote a letter to Dr Hamburg citing several reasons why current conflict of interest rules “do not create an unreasonable burden and are not preventing the agency from getting expert advice.”

It cited a survey showing that the number of waivers issued for FDA advisers “has never exceeded 5%, well below the legal cap of around 13%,” and a study in Health Affairs showing that half of research academics, around a third of whom are full professors, have no industry ties.

And the letter included a copy of a BMJ article that contained a list of around 100 experts without industry ties (BMJ 2008;337:a930, doi:10.1136/bmj.a930).

Paul Thacker, an investigator with the Project on Government Oversight, told the BMJ that vacancy rates on FDA panels reached 30% in 2009. “The rate has been falling ever since and is now in the mid-20s,” he said. “It’s like any new rule: it takes time at first to figure out how to deal with it.”

Curt Furberg, a former adviser to the FDA and one of the 100 cited experts without industry ties, refuted the FDA’s claim. “I don’t buy it. I think you can get people who have no conflicts.” But he warned that it would be a mistake to overlook the influence of industry ties on advisers. Referring to valdecoxib (marketed as Bextra), the non-steroidal anti-inflammatory drug withdrawn because of concerns about cardiovascular risk (BMJ 2005;330:862, doi:10.1136/bmj.330.7496.862-a), he said, “Before Bextra was pulled off the market, nine of the 10 FDA advisers with industry ties voted to keep it on the market.”

Sidney Wolfe, director of Public Citizen’s health research group and another of the cited 100, concurred. “If anything we need to tighten regulations, not loosen them,” he told the BMJ.

Meanwhile conflict of interest issues also prompted the Republican senator Charles Grassley of Iowa to write on 4 August to the director of the US Office of Management and Budget, expressing concern about recent reports that the office may be attempting to weaken conflict of interest rules for doctors in respect of their financial ties to industry. The rules were proposed in May 2010 by the Department of Health and Human Services.

Senator Grassley said that he was “troubled that taxpayers cannot learn about the outside income of the researchers whom the taxpayers are funding,” as the office had reportedly removed the requirement for a publicly available website that would publish this sort of information.

Notes

Cite this as: BMJ 2011;343:d5070