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Brian Vastag

JAMA. 2002;288:2111.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

A bill passed by the House of Representatives (HR 3580) would charge medical device manufacturers $139 000 for each product approved by the FDA. The bill was spurred by concerns that the agency takes too long to review applications.

At press time, the Senate had not yet considered its version of the bill, leading to speculation that pressure from device manufacturers would scuttle the legislation. The 1100-member Advanced Medical Technology Association reportedly agreed to the House bill after inclusion of a provision that exempts companies with up to $10 million in annual sales.

However, another group, the Medical Device Manufacturers Association (MDMA), comprising 130 large companies, wants the exemption to apply to companies with up to $100 million in annual sales. The MDMA called the user fees, which the FDA charges drug companies to review new drug applications, "a tax on innovation."

In addition, concerns were raised about a . . . [Full Text of this Article]