FDA Tightens Rules On Conflicts Of Interest
According to the new rules announced for the Food and Drug Administration’s advisory committee, expert advisers to the U.S. government who receive money from a drug or device maker will now be prohibited from voting on whether to approve that company’s products.
When doctors receive more than $50,000 from a company, or a competitor of a company, whose product is of topic, will no longer be allowed to serve on the committees. Although those who received less than that amount in the previous year can still join a committee and participate in its discussions.
A “significant number” of current advisers to the agency will be affected by the new policy, Randall Lutter, its acting deputy commissioner said.
These new rules are among the first major changes made by Dr. Andrew von Eschenbach since confirmed late last year as the commissioner of the Food and Drug Administration.
Advisory boards recommend drugs for approval and, in some instances, removal from the U.S. market, and their votes can have a very monumental influence on drug companies’ stock prices and profits.
“The $50,000 threshold is something that we think strikes an appropriate balance” between getting smart advisers and reassuring the public that the advisers’ counsel is not tainted, Lutter said.
The new rules were initiated to respond to an increasing number of critics who contend that drug and device makers have unfairly impacted the agency’s approval process by monetarily compensating those who serve on its advisory panels.
In one widely known example, 10 of the 32 advisers who voted in 2005 to allow the painkiller Bextra to remain on the market, and to let the painkiller Vioxx to return to the market despite all of the safety worries associated with the drug, had received money from the makers of the drugs.
Under the new rules, their votes would not have counted, and the committee would have voted to keep both drugs off the market, consequently saving lives.
In the end, the agency removed Bextra from the market anyway, and Vioxx has never returned. But the controversy surrounding that panel’s vote and similar ones ruined the image of the review process and provided new material for critics of the agency to consider.
While there were some conflicts under the old rules that led to total exclusions, like an adviser’s holding $100,000 of stock in the company at issue, the agency could decide to disregard almost any other potential financial conflict, including tens of thousands of dollars in income from a company that might have business before it.
A U.S. congressional committee has begun an investigation into the marketing and regulation of widely used anemia drugs that have recently fostered safety concerns.
The House Committee on Energy and Commerce sent letters to Amgen and to Johnson & Johnson, who market the anemia drugs, requesting information about when they knew of possible risks and how they had promoted the products.
The letters also asked them to suspend any consumer advertising of the drugs and any incentive programs directed towards doctors who prescribe them until after the FDA has had sufficient time to determine whether further safety precautions are necessary.
The products include: Epogen and Aranesp from Amgen and Procrit from Johnson & Johnson — are all forms of erythropoietin, a protein made by the kidney to spur production of red blood cells. The drugs are mainly used to treat anemia caused by kidney failure or cancer chemotherapy and have combined worldwide sales of roughly $10 billion a year.
A panel is scheduled to meet May 10, 2007 to discuss the safety of the drugs.