APRIL 2003

Molecular era shakes up FDA

Drug reviews collapse into CDER

By: C.P. Kaiser

The rapid advancement of molecular imaging, coupled with increasing use of therapeutic agents, is shaking things up at the FDA.

Many scientists, clinicians, and industry personnel who believe that the future of therapy lies with combinations of agents have questioned the FDA's readiness for this paradigm shift.

The FDA has responded with a series of changes aimed at improving the process by which novel imaging and therapeutic technologies are evaluated.

Late last year, the FDA established the Office of Combination Products, which will serve to streamline the pre- and postmarket processing of drug, biologic, and device combination products. The OCP will decide which center has jurisdiction over these products. Drug-eluting stents or laser-activated drugs, for example, could be sent either to the Center for Devices and Radiological Health (CDRH) or to the Center for Drug Evaluation and Research (CDER).

Companies had complained that delays caused by jurisdictional confusion cost them millions of dollars. According to industry observers, the National Cancer Institute is concerned that regulatory obstacles implemented by the FDA and the Centers for Medicare and Medicaid Services could jeopardize its multimillion-dollar investment in molecular research. Additionally, the FDA can expect to receive substantially more combination products for review as technological advances continue to merge therapeutic products and blur the historical lines of separation between the agency's medical product centers.

To produce a more effective and consistent review program for human drugs and biologics, the FDA recently consolidated new pharmaceutical product reviews into the CDER. These were previously handled by the CDER and the Center for Biologics Evaluation and Research (CBER). And certain biologic product reviews have been transferred from CBER to CDER: monoclonal antibodies intended for therapeutic use; cytokines, growth factors, enzymes, and interferons (including recombinant versions) intended for therapeutic use; and proteins intended for therapeutic use that are extracted from animals or microorganisms, other than human blood and blood components and derivatives.