US Industry Views FDA Reform, PDUFA

4 May 1997

The Pharmaceutical Research and Manufacturers of America and theBiotechnology Industry Organization support the five-year renewal of the Pharmaceutical Drug User Fee Act, level funding for the Food and Drug Administration and FDA improvement legislation, Amgen chairman Gordon Binder has told a recent US Senate Labor and Human Resources Committee hearing.

The FDA and industry have developed a legislative framework that would renew PDUFA for five more years, continue cutting FDA review times, and for the first time, address the drug development phase. In exchange, industry would pay at least 21% more in user fees, allowing the FDA to continue PDUFA without interruption and implement new performance goals, enabling patients to receive new drugs 10-16 months sooner. The FDA would, in exchange for higher fees, undertake many comprehensive improvements, and establish quantifiable, measurable timelines and performance goals. It would be able to acquire and install a paperless, electronic information system to process all required submissions and applications, a major help in improving efficiency and productivity.

Urges Level Funding For FDA FDA funding was not a specific issue in the hearing, but Mr Binder said that without fiscal 1998 funding at least equal to 1996's, PDUFA will be negated. Without level funding, fees would be used for general deficit cuts and not to benefit patients. In effect, the administration proposes an 8% cut for the FDA in fiscal 1998 and a 13% cut in the budget for human-use drug approvals, he said; without level funding there would be a substantial slowdown in drug development and review times.

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