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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,

Susan L-J Dickinson
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, get needed drugs to market faster.

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...

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