Fees Proposed to Speed FDA Drug Approval : Pharmaceuticals: Legislation would have companies pay for more reviewers, expediting new medicines. Agency’s chief supports the idea.

The Food and Drug Administration and the drug industry are nearing an agreement in which pharmaceutical companies would pay the agency to hire more examiners to review applications, thus speeding the approval process for new prescription drugs, FDA Commissioner David Kessler said Monday.

User fees paid by companies that file applications would cut the review period almost in half, giving consumers quicker access to new medicines, Kessler told the House Energy and Commerce subcommittee on health and the environment.

“To get more drugs on the market, the only answer is to provide more reviewers,” he said.

Kessler said user fees are necessary because “traditional sources of funding are no longer enough to do with reasonable speed the job that needs to be done.”

Draft legislation proposed by subcommittee Chairman Henry A. Waxman (D-Los Angeles) would require companies to pay the FDA $150,000 for each drug application, along with two lesser fees.

The fees would generate $325 million over five years for the FDA, allowing the agency to hire 620 additional people to review applications, Kessler said.

The FDA takes about 20 months to review prescription drugs, and eight to 12 months to review emergency drugs. The agency hopes to cut those review periods almost in half.

“That would be a dramatic change in the way the FDA has done business,” Kessler said.