The US Food and Drug Administration has agreed with pharmaceutical manufacturers on an almost 30% increase in the “user fees” that drug makers pay to the FDA to expedite approval of new drugs. The FDA has also consulted patient advocates, consumer groups, health professionals, and academic researchers about the new rules.
User fees are annual fees paid by pharmaceutical manufacturers. The FDA wants them to increase by $87.4m to $392.8m (£199.0m; €303.7m). The FDA now gets more than half of its funding from user fees.
The agency will hold a public meeting in Washington, DC, on 16 February to hear comments and will then ask Congress to approve the new rules.
The FDA says the largest portion of the new fees—$29.3m—will help it increase postmarketing surveillance of newly approved drugs beyond the current three years. The agency has been criticised for not detecting the cardiovascular risks of COX 2 (cyclo-oxygenase-2) inhibitors, such as Vioxx, and the suicide risks of antidepressants.
In future, the FDA proposes to look at data other than spontaneous adverse event reports, including population based epidemiological data and other types of observational data to detect drug problems.
The FDA also proposes a plan to improve naming, labelling, and packaging of drugs to avoid confusing names and packages.
The fees will also improve guidance for FDA reviewers; improve information technology by moving the agency and the industry towards an all electronic environment; and cover costs of the agency's move to a new facility in the area.
In addition, the agency recommends setting up a separate new user fee programme of $6.2m in the first year to cover the costs of reviewing direct to consumer television advertising of prescription drugs. The review is voluntary.
The fees were established by the Prescription Drug Use Fee Act in 1992 to help the FDA speed up new drug approvals. The act authorising the fees must be re-approved by Congress every five years and then must be signed by the president.
The fees are paid by pharmaceutical firms when they file new drug applications. They are calculated based on their number of manufacturing factories in the United States and the number of drugs they sell in the US.
Last year, the Institute of Medicine said in Preventing Medication Errors: Quality Chasm Series that the FDA doesn't have the ability to monitor drugs once they are approved; doesn't have the legal authority to act when adverse effects are discovered; and is underfunded.
The FDA's latest recommendations were published in the Federal Register (2007;7:1743-53). It acknowledged that some consumer groups said they wanted all human drug reviews to be done with government rather than industry funding, but “they generally considered fee-funding to be inevitable.”
Sidney Wolfe, director of the Public Citizen's Health Research Group, told the Chicago Tribune, “The FDA's critical drug regulatory functions are too important to be tainted and compromised by direct funding from the very companies whose drugs the agency reviews for safety” (www.chicagotribune.com, “FDA wins deal on drug fees,” 12 Jan 2007).
Bill Vaughan, senior policy analyst for Consumers Union, a non-profit making group, said, “At a time when countless drugs have safety problems, it isn't enough to just rely on money paid by the pharmaceutical industry to fund needed drug safety reforms … Consumers Union supports legislation introduced in the last Congress [but not passed] that would reform drug safety laws and give the FDA more power to perform postmarketing safety studies once problems arise.” The organisation also supports public reporting of clinical trial results “so patients and doctors know about side effects and drug risks.” Such reporting is not now required.