FDAnews Drug Daily Bulletin

AMID CRITICISM, FDA WITHDRAWS FINAL CGMP RULE EXEMPTING PHASE I STUDIES

May 3, 2006
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The FDA is withdrawing its direct final rule exempting most investigational drugs from complying with current Good Manufacturing Practices (cGMP) amid criticism of the proposal from a variety of stakeholders.

The agency introduced the proposal as part of its Critical Path initiative to speed innovative treatments to market. But various industry and activist groups argued that this approach eliminated a necessary safety net preventing patients from exposure to unsafe or ineffective drugs and could result in additional burdens on industry.

Under current regulations, even initial, small-scale drug studies must go through extensive cGMP requirements. These requirements include undertaking reviews to ensure the drug is safe, effective and meets all of the quality and purity characteristics it is purported to possess.

Under the final rule the agency would have excluded investigational drugs from cGMP requirements. But groups as varied as Public Citizen, the Biotechnology Industry Organization (BIO) and the Parenteral Drug Association (PDA) opposed the agency's proposal.

However, these criticisms will not prevent the agency from eventually implementing this exemption, Peter Lurie, the deputy director of Public Citizen's Health Research Group, told FDAnews. Instead, the FDA will have to go through a formal notice and comment review process, responding to these concerns before finalizing the rule.

The agency's efforts to implement the rule without proper notice and comment was a "kind of sneaky end run" around necessary administrative procedures, he said. FDA guidance on direct final rules states that these rules can only be proposed when changes are not substantive. But the proposed Phase I rule is a substantive change in agency policy and should go through the necessary administrative steps, Lurie added. (http://www.fdanews.com/did/5_86/)