The law that requires drug companies to pay “user fees” to the US Food and Drug Administration for every drug they submit for approval should not be renewed when it comes before Congress later this year, says a former editor of the New England Journal of Medicine.
Writing an open editorial in the Boston Globe, Marcia Angell, who worked for the journal between 1979 and 2000, most recently as editor in chief, said that the Prescription Drug User Fee Act has, in effect, “put the FDA on the payroll of the industry it regulates” (www.boston.com, 26 Feb, “Taking back the FDA”).
The act, which was passed by Congress in 1992, “put the fox in the chicken coop” and has changed the focus of the agency, which now serves the industry rather than the public, says Dr Angell.
Nearly all of the $300m (£153m; €230m) that the fees bring to the agency every year have been earmarked to speed up the approval process, she says, money “which the companies recoup many times over by getting their drugs to market faster.”
“But while it's a small investment for drug companies, it's a lot of money for the agency, and it has drastically changed the way it operates—creating a disproportionate emphasis on approving brand-name drugs in a hurry,” adds Dr Angell.
“Consequently, the part of the agency that reviews new drugs gets more than half its money from user fees, and it has grown rapidly. Meanwhile, the parts that monitor safety, ensure manufacturing standards, and check ads for accuracy have languished or even shrunk.”
In addition, the part of the agency that approves generic drugs has become so small that it takes twice as long for generic drugs to be approved as brand name drugs. Dr Angell says that there is currently a backlog of 800 generic drugs waiting to be approved. The delay works in the drug companies' favour, as they are able to add billions of dollars to their profits while their products have no competition from generic products.
Dr Angell also criticises the agency for failing to enforce commitments given by companies at the time of approval of a drug to conduct further safety studies once the drug is on the market. More than 70% of 1200 studies that are currently outstanding have not even begun.
“The FDA is strangely silent about this inexcusable dereliction. When questioned, it weakly protests that it doesn't have the authority to compel the research. In fact, it has enormous leverage, since it can withdraw drugs from the market,” she says.
Her article also criticises the agency's refusal to release unfavourable results of research trials and its waivers of declarations of competing interests for some outside experts who help evaluate drugs.
As the user fee law is subject to renewal every five years and was last backed in 2002, this year provides an opportunity for Congress to let the law die.
“At $300m to $400m a year, the equivalent of about a day [of US spending] in Iraq, Congress can easily afford to buy this vital agency back for the public, and it should,” concludes Dr Angell.
In a separate attack David Kessler, a former commissioner of the FDA, blamed mass marketing of drugs to consumers by drug companies for a lack of confidence in the agency's ability to ensure safety of drugs.
Dr Kessler, who was taking part in a panel discussion at the George Washington University School of Public Health, said an increase in side effects was inevitable, because the agency relies on the results from a relatively small number of patients in clinical trials to determine safety. The question of whether it is “the right drug, the right person, the right disease, and the right dose” is often not asked, he said.
Instead drugs are heavily promoted by companies, which are determined to “sell as many drugs as they can.”
Dr Kessler called for limits to be set on marketing drugs “as just another commodity.”