FDA User Fees To Speed Drug Review

Despite some concerns over the potential for harm to innovation at small firms and undue influence and increased bureaucracy at the agency, government and industry analysts are expressing enthusiasm for a statute requiring pharmaceutical companies to pay "user fees" to the United States Food and Drug Administration. The additional 600 reviewers the fees will finance, they say, will result in decreased review time that will reduce corporate cost, increase government efficiency, and, ultimately,

Written bySusan L-J Dickinson

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There is even the possibility--though no drug maker will commit to it--that savings will be passed on to the consumer in terms of lower prices on pharmacy shelves.

The new legislation, aimed at clearing the logjam of drugs waiting for approval at FDA, requires pharmaceutical firms to pay $330 million in user fees directly to the agency over the next five years.

With the additional reviewers these fees will provide, the agency has pledged to cut the time it takes to review new products in half by October 1997.

Testifying on the bill before the Senate Committee on Labor and Human Resources, Irwin Lerner, president and CEO of Hoffmann-La Roche, Inc., Nutley, N.J., commented: "It has been refreshing to see how well the private and public sector can work together for the public good."

But other observers, including some physicians and legislators, are uncomfortable with the close ties the bill ...

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