Health Care Issues

Delays at the FDA Kills Innovation

Those who have followed the battle of developers to win Food and Drug Administration approval of the excimer laser say the case illustrates the agency's confrontational attitude toward medical professionals that frequently descends into arrogance.

The laser is a revolutionary medical device that actually reshapes the eye to correct nearsightedness and astigmatism.

  • Since 1988, over fifty countries have started using it -- while the FDA was taking eight years to approve the device for use in the U.S.

  • The delay invited industrial espionage -- with proprietary plans for one firm's laser actually being stolen from FDA files and mailed to the company's chief competitor.

  • While the agency has at last approved two old-technology excimer lasers, it still has not approved the most advanced design.

Through a series of restrictions and regulations, the FDA has sought to discourage innovative doctors from building or importing the lasers. Observers say American patients seeking treatment must travel to Canada or Colombia to benefit from the U.S.-developed technology.

Source: William Ellis and Mark Stern, "The FDA's 'Us Vs. Them' Mind-Set," Investor's Business Daily, December 20, 1996.


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