FDA needs to modernize clinical trial requirements, BIO chief says

05/9/2014 | American City Business Journals

BIO President and CEO Jim Greenwood acknowledged the FDA's efforts to adopt a more sophisticated approach in evaluating new drugs, but he stressed the need for the agency to adapt to new clinical trial designs particularly for drugs designed to treat fatal, rare diseases. Greenwood said he's focused on protecting the pharmaceutical industry from lawmakers who want to place heavier burdens on drugmakers. The 340B Drug Pricing Program implemented in 1992 costs drugmakers around $6 million per year, for example. "We're trying to educate Congress on how expensive this program is," Greenwood said.

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