Drug companies would fund tests under US plan

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The Independent Online
THE pharmaceutical industry and US regulators are near agreement on a plan that would see the companies pay the cost of hiring new drug testers, breaking the long bottleneck in winning approval of new products.

Under the plan, pharmaceutical and bio-technology firms would pay the US Food and Drug Administration roughly dollars 75m a year to have their new drugs examined. This would allow the agency to hire 600 more scientists and cut approval delays by half.

But some critics have suggested that such user fees might compromise FDA standards, affording the industry undue influence over the selection of independent examiners.

One version of the proposal would see the drug companies pay the FDA dollars 150,000 to cover the cost of each application, whether the product was eventually approved or not.

Large manufacturers such as Britain's Glaxo, Merck, Upjohn and Genentech could also expect to pay annual fees of dollars 50,000, plus dollars 5,000 for each FDA-approved drug currently on the market in the US.

Because of limited funding from the US goverment, the FDA has accumulated a backlog of applications.

It now takes an average of 20 months to win approval for most new drugs, and up to a year for life-saving drugs given priority examination.

The situation is likely to worsen considerably in coming years, as the number of new bio-tech products coming to the market is expected to multiply FDA applications 100-fold by the end of the decade.

The cost to the drug producers will more than likely be offset by the increased revenues from earlier approval, an industry spokesman said.

'The most profitable period for any drug is its introductory period, and each month saved at the FDA can mean substantial revenues,' said Viren Mehta, a New York pharmaceutical industry specialist.

But Mr Mehta warned that there were legitimate concerns that user fees might jeopardise the intregrity of the system by giving manufacturers too much say in the review process.

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