Monday, April 3, 1995
WASHINGTON - Under increasingly persistent demands from industry
and Congress to reduce the regulatory burdens to the commercialization of new
therapeutics, the FDA is organizing home-grown changes in the drug development
and approval process, including focusing more of its attention and resources
on Phase I and II trials.
In addition, the Center for Biologics Evaluation and Research
(CBER) is working with the Center for Drug Evaluation and Research (CDER) on
a joint document outlining their philosophical basis for approval decisions
for proposed therapies that address serious conditions for which no effective
CBER Deputy Director Michael Beatrice, who discussed the center's
plans in an interview with BioCentury last week, declined to speculate on when
the document will be published. He stressed that CBER and FDA are just starting
a number of reform initiatives and it is too early to predict the scope of changes.
However, he said the goal was to introduce proposals that would "radically change"
The second-in-command at CBER said the center is looking for ways to improve the entire drug development process. He attributed the recent rash of late-stage biotech product failures to poor screening and suggested that FDA can work with companies to improve decisions in early stage clinical trials.