WASHINGTON U.S. lawmakers likely will change the criteria for advisers reviewing new medicines next year because of complaints that the rules meant to prevent conflicts of interest make it harder to find real experts.
Congressional lawmakers may require the Food and Drug Administration to relax the rules that bar advisers from reviewing a drug if they have even indirect financial ties to related manufacturers, as part of an FDA funding bill.
Senators raised the issue during a hearing last week at the Health, Education, Labor and Pensions Committee.
"Based on today's hearing and the comments from Senators Franken and Enzi, I think there is a good chance that this issue could end up in the final FDA user fee bill," said a congressional staff member familiar with the matter. The staff member was referring to Mike Enzi, the top Republican on the committee and Al Franken, a Democratic committee member.
Fees from makers of drugs and medical devices provide more than a third of the FDA's funding, which means that the bill often serves as a vehicle for broader FDA-related changes.
The agency often must delay panel meetings while it searches for experts without conflicts, lawmakers and FDA officials say. Top doctors are usually the ones drugmakers hire as speakers or consultants.
"We have had difficulty in recruiting highly qualified people. And we've had delays in having panels because of this," Dr. Janet Woodcock, head of the FDA's drugs center, told a House of Representatives hearing earlier this month.
The result is that 23 percent of FDA advisory panels have vacancies, more than double the agency's stated goal, according to the FDA's quarterly report at the end of May.
THE BEST QUALIFIED
The FDA is not required to follow the recommendations of its advisers, but it usually does, leading to scrutiny of who is providing advice.
The FDA tightened guidelines in 2007 to minimize industry ties that could sway a panelist's view, partly inspired by the scandal with Merck's pain reliever Vioxx.
Ten of the 32 panelists advising the FDA on the drug consulted for drugmakers. Nine of the 10 recommended putting the drug back on the market after it was pulled in 2004 over concerns about heart risk.
The restrictions go too far, say lawmakers who want the FDA to approve more new medicines, in part because they promote American jobs.
"No longer can we deny experts simply because they have ties to industry," said Georgia Representative Phil Gingrey during a House of Representative hearing on FDA funding last month. The committee's chairman, Fred Upton from Michigan, called the conflict of interest rules "rigid and unrealistic."
Industry executives, who want the FDA to speed drug approvals, also support relaxing the rules. Biogen Idec CEO George Scangos said the guidelines "exclude a lot of people who would be the best qualified."
WHO IS BIASED?
Dr. Abraham Thomas, a specialist in diabetes, obesity and bone and mineral disorders, would seem to be the perfect expert to advise the FDA about a new AstraZeneca and Bristol-Myers Squibb diabetes pill, which was also tied to some cancer risks and liver and bone injury.
But Thomas works at Henry Ford Hospital, which received as much as $50,000 to study a competing diabetes medicine.
Under the guidelines, even indirect financial links to a competitor barred Dr. Thomas from participating in an advisory panel for the diabetes pill, called dapagliflozin, without a waiver. The FDA decided to grant him one of six waivers given this year, citing his expertise.
Limits on the number of waivers the agency can issue mean the FDA must exclude some experts, which critics say means settling for advice from second-tier specialists who make uninformed decisions.
Ira Loss of Washington Analysis calls the current rules "overkill" for lumping together those with a direct financial relationship to a company or competitor with those who have more indirect links, such as Dr. Thomas.
"If a doctor is involved in a clinical trial, he shouldn't be allowed on the panel," he said. "But the rules about the institution where you work. I think that's ridiculous. ... The result is that you have people on the advisory committee who have no idea what they're talking about."
A THOROUGH SEARCH
Others say that the agency is not looking hard enough.
A March study from the University of Pennsylvania's School of Medicine found that 44 percent of cardiologists do not have industry ties.
The study "flat out dismisses this idea that there are no experts who don't have relationships," said Eric Campbell, associate professor of medicine at Harvard University and one of the study's authors.
"There are lots of people out there who are smart and who don't have conflicts of interest," said Sid Wolfe of the consumer advocacy group Public Citizen. "It just takes much more work for the FDA to find them. But the result is you have much less tainting of the panel discussion.
Advocates of stronger rules say the agency lacks the power to force full disclosure, and defines conflicts too narrowly. Members with past financial ties to a company are not considered under the rules, said Diana Zuckerman, president of the National Research Center for Women & Families.
"Those ties affect their voting, whether or not they currently are on the payroll," she wrote in an email. "Research shows that even small gifts, such as an expensive meal or a $500 honorarium, will affect how a doctor or faculty member feels about a company and could affect how they vote."
Consumer advocates and lawmakers are more likely to agree when it comes to reviewing drugs for rare diseases.
"If waivers need to be granted, we hope that the FDA will limit them to rare and neglected diseases where there are truly few experts available," Consumers Union wrote in comments to the FDA's conflicts of interest regulation.
FDA Commissioner Hamburg said calls to relax some conflict of interest rules were "a valid concern.
"Especially when you're talking about rare and unusual diseases, getting new experts is more challenging, as many were involved in the development or trials of drugs under consideration," she told the Senate hearing last week.
"I'm not surprised this issue keeps coming up," Hamburg said after the hearing.
(Corrects 11th paragraph to show that 10 of the 32 panelists consulted for drugmakers, not "the drugmaker". And that nine of those 10 recommended putting Vioxx back on the market, not all 10, as first sent)
(Additional reporting by Lisa Richwine; Editing by Michele Gershberg and Robert MacMillan)