Expert advisers to the government who receive money from a drug or device maker would be barred for the first time from voting on whether to approve that company’s products under new rules announced Wednesday for the F.D.A.’s powerful advisory committees.
Indeed, such doctors who receive more than $50,000 from a company or a competitor whose product is being discussed would no longer be allowed to serve on the committees, though those who receive less than that amount in the prior year can join a committee and participate in its discussions.
A “significant number” of the agency’s present advisers would be affected by the new policy, said the F.D.A. acting deputy commissioner, Randall W. Lutter, though he would not say how many. The rules are among the first major changes made by Dr. Andrew C. von Eschenbach since he was confirmed as commissioner of food and drugs late last year.
Advisory boards recommend drugs for approval and, in rare cases, removal, and their votes can have enormous influence on drug company fortunes.
“The $50,000 threshold is something that we think strikes an appropriate balance between” getting smart advisers and reassuring the public that their advice is not tainted, Dr. Lutter said.
The changes are intended to respond to a growing chorus of critics who contend that drug and device makers have hijacked the Food and Drug Administration’s approval process by paying those who serve on the agency’s advisory panels.
In one famous example, 10 of the 32 advisers who voted in 2005 to allow the painkiller Bextra to remain on the market and the painkiller Vioxx to return to the market despite safety worries had taken money from the drug makers. Under the new rules, their votes would not have counted and the committee would have voted to keep both drugs off the market.
In the end, the F.D.A. removed Bextra from the market anyway, and Vioxx has never returned. But the controversy surrounding that panel’s vote, and similar ones, tarnished the process and provided new fodder for critics in Congress.
Representative Maurice D. Hinchey, Democrat of New York, said he was delighted with the change, which will not become final until the end of a 60-day comment period.
“So many lives have been lost as a result of the failure of the F.D.A. to review drugs properly,” said Mr. Hinchey, who for two years has proposed legislation to ban agency advisers from having financial conflicts of interest. “The F.D.A. is now moving back to where it was supposed to be, a principled agency that protects the people.”
“F.D.A. is trying to strike a balance here,” Mr. Troy said, “and they would rather strike it themselves than have it struck for them.”
Drug makers routinely hire doctors as consultants for marketing and research. The New York Times reported on Wednesday that records in Minnesota show that at least 20 percent of licensed physicians in the state received money from drug makers between 1997 and 2005 — an average of $10,000.
Some conservatives were not happy with the new rule.
“I think it’s likely to improve the quality of the recommendations, remove the taint of the recommendations and improve the credibility of the recommendations,” Dr. Lurie said.
Advisory panels are important to the F.D.A. not so much because they provide the agency with expert advice — the F.D.A. can get that privately any time — but because they serve to increase public confidence in the agency’s decisions.
Indeed, such doctors who receive more than $50,000 from a company or a competitor whose product is being discussed would no longer be allowed to serve on the committees, though those who receive less than that amount in the prior year can join a committee and participate in its discussions.
A “significant number” of the agency’s present advisers would be affected by the new policy, said the F.D.A. acting deputy commissioner, Randall W. Lutter, though he would not say how many. The rules are among the first major changes made by Dr. Andrew C. von Eschenbach since he was confirmed as commissioner of food and drugs late last year.
Advisory boards recommend drugs for approval and, in rare cases, removal, and their votes can have enormous influence on drug company fortunes.
“The $50,000 threshold is something that we think strikes an appropriate balance between” getting smart advisers and reassuring the public that their advice is not tainted, Dr. Lutter said.
The changes are intended to respond to a growing chorus of critics who contend that drug and device makers have hijacked the Food and Drug Administration’s approval process by paying those who serve on the agency’s advisory panels.
In one famous example, 10 of the 32 advisers who voted in 2005 to allow the painkiller Bextra to remain on the market and the painkiller Vioxx to return to the market despite safety worries had taken money from the drug makers. Under the new rules, their votes would not have counted and the committee would have voted to keep both drugs off the market.
In the end, the F.D.A. removed Bextra from the market anyway, and Vioxx has never returned. But the controversy surrounding that panel’s vote, and similar ones, tarnished the process and provided new fodder for critics in Congress.
Representative Maurice D. Hinchey, Democrat of New York, said he was delighted with the change, which will not become final until the end of a 60-day comment period.
“So many lives have been lost as a result of the failure of the F.D.A. to review drugs properly,” said Mr. Hinchey, who for two years has proposed legislation to ban agency advisers from having financial conflicts of interest. “The F.D.A. is now moving back to where it was supposed to be, a principled agency that protects the people.”
“F.D.A. is trying to strike a balance here,” Mr. Troy said, “and they would rather strike it themselves than have it struck for them.”
Drug makers routinely hire doctors as consultants for marketing and research. The New York Times reported on Wednesday that records in Minnesota show that at least 20 percent of licensed physicians in the state received money from drug makers between 1997 and 2005 — an average of $10,000.
Some conservatives were not happy with the new rule.
“I think it’s likely to improve the quality of the recommendations, remove the taint of the recommendations and improve the credibility of the recommendations,” Dr. Lurie said.
Advisory panels are important to the F.D.A. not so much because they provide the agency with expert advice — the F.D.A. can get that privately any time — but because they serve to increase public confidence in the agency’s decisions.
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