Reform bill a preview of BIO agenda

WASHINGTON - Rep. Jon Fox, R-Penn., a member of the Committee on Government Reform and Oversight, plans to introduce an FDA reform bill this week that would limit the agency's ability to require construction of full-scale manufacturing facilities for biologicals prior to approval, instructs FDA to develop guidelines for harmonizing preclinical and clinical investigations regulations with those of other countries, and limits the agency's authority to require lot testing for biologicals.

The bill would instruct the Secretary of Health and Human Services to establish two sets of good manufacturing practices for drugs and biologicals, one for those that can be well characterized by physical or biological methods and one for those that cannot. It also limits the FDA's ability to require pre-notification of manufacturing changes...