6 April, 2002
Deborah Josefson Nebraska
The US Food and Drug Administration and the drug companies it regulates have reached a tentative agreement to increase the fees the companies pay to the FDA—in return for speedier reviews of drug and medical devices.
Although a portion of the increase is to be earmarked for safety monitoring, consumer groups question whether there is an inherent conflict of interests at play, because much of the FDA’s funding now comes from the industry it regulates, rather than from an independent third party. Dr Sidney Wolfe, of the consumer group Public Citizen, argues that adequate public funding is the ideal solution and wants to see a "no strings" agreement if the FDA is forced to rely more heavily on funding from drugs companies.
"The FDA’s message to the public has been confused, because it has maintained that people have benefited because more products are available more quickly, yet so many people have been needlessly harmed by these new products," he said. "The public is not interested in more drugs more quickly. Rather, they are interested in better drugs."
The fee increase is an extension of the Prescription Drug User Fee Act of 1992, which is due for renewal in September. Before the act was introduced, the FDA took an average of 2.5 years and as much as 8 years to review a new application. Much of the delay was attributed to insufficient personnel and time, rather than difficulties with the applications themselves.
The act originally required pharmaceutical companies to submit a fee of $200 000 (£140 000; €£229 000) when they applied for review and approval of a new drug. The latest increases—amounting to $223m by next year and $260m by 2007—has to be approved by Congress. If it is approved, the pharmaceutical companies will be paying over 51% of the cost of reviews and approvals of new drugs.
According to FDA documents, fees collected from drug companies have had a dramatic impact on streamlining the review process. The additional funding has meant the FDA could recruit more staff, and as a result the agency has increased the proportion of applications that were approved. Before the act was implemented, about 60% of new drug applications were ultimately approved. Now, nearly 80% are approved.
Speedier reviews have allowed drugs to reach the market more quickly, but safety may have been compromised in the process. In recent years the FDA has rapidly approved a number of new drugs, only to have to take them off the market soon afterwards. These include Rezulin (troglitazone) for diabetes, mibefradil for hypertension, dexfenfluramine for weight loss, and bromfenac sodium, an analgesic.
The FDA’s comments on the fee increase are at http://www.fda.gov/oc/pdufa/default.htm