Is the FDA approving drugs too fast?BMJ 1998; 317 doi: https://doi.org/10.1136/bmj.317.7163.899 (Published 03 October 1998) Cite this as: BMJ 1998;317:899
Probably not—but drug recalls have sparked debate
- J D Kleinke, Healthcare economist,
- Scott Gottlieb, Clegg fellow
- Health Strategics Network, 510 South Dahlia Circle, B305, Glendale, CO 80246, USA
Debate in the United States about the optimal amount of time required by the Food and Drug Administration for adequate testing of new drugs has raged since 1962, when Congress established formal criteria for proving drug safety and effectiveness. Through much of the past decade the FDA has been accused of delaying drug approvals: now it is accused of acting too hastily in approving drugs that have later had to be withdrawn.
The height of the initial criticism came in 1995, with the election of a Republican majority in Congress that favoured full privatisation of all healthcare matters. The Republican speaker of the House of Representatives, Newt Gingrich, referred to the FDA as “job killers”: its excessive reviews, he claimed, delayed the launch of new drugs and thereby forestalled growth for the pharmaceutical industry.1
Although the agency disputed that its reviews were excessive, the FDA had already argued that the increase in the number of drugs seeking approval had stretched the agency beyond its means and was indeed …