- David P Kao, fellow, cardiovascular medicine
- 1University of Colorado Health Sciences Center, Academic Office 1, 12631 E 17th Avenue, Suite 7102, Aurora, CO 80045 USA
- Accepted 16 September 2008
Institutions responsible for monitoring drug safety have been criticised widely after the withdrawal of drugs such as rofecoxib because of safety concerns. An estimated 20 million patients received prescriptions for rofecoxib over five years before the drug was withdrawn, and events attributable to rofecoxib may number in tens to hundreds of thousands.1 Regulatory bodies such as the US Food and Drug Administration have simultaneously been under pressure to reduce drug approval times to ensure timely availability of new drugs. However, concerns have been expressed that deadlines for approving drugs have reduced the focus on safety.2 3 4
New efficiencies in drug marketing exacerbate the problem because rapid adoption of new drugs can quickly expose large numbers of patients to unknown risks. Here, I review trends in drug approval times in the United States, the mechanism by which this has been achieved, and concerns raised by this approach. I then discuss an example of the speed with which a new product may be adopted once approved and suggest improvements to drug safety surveillance systems.
Trends in drug approval
Faced with staffing and budget limitations on drug approval, the US Congress passed the Prescription Drug User Fee Act in 1992. This authorised the FDA to collect fees from drug manufacturers and use the revenue to hire additional staff to review drugs and improve its administrative infrastructure. In return, the FDA established goals of reviewing 90% of priority new drug applications within six months and 90% of standard new drug applications within 12 months. As a result, the mean review time in the US decreased from 33.6 months during 1979-86 to 16.1 months during 1997-2002.5 The act …