Legal foundations of adaptive licensing.

In April 2012, MIT's Center for Biomedical Innovation and the European Medicines Agency (EMA) cosponsored a workshop on legal foundations of adaptive pharmaceuticals licensing. Past and present attorneys from the US Food and Drug Administration (FDA), the EMA, and Health Sciences Agency Singapore (HSA) found that existing statutes provided authority for adaptive licensing (AL). By contrast, an attorney from Health Canada identified gaps in authority. Reimbursement during initial phases of adaptive approaches to licensing was deemed consistent with existing statutes in all jurisdictions.

FDA reform in Congress: interview with Peter Barton Hutt. Food and Drug Administration. Interview by John S. James.

AIDS: Peter Barton Hutt, one of the world's leading experts on Food and Drug Administration (FDA) law, addresses issues concerning rapid approval for protease inhibitors, funding for development of AIDS drugs, and legislative processes impacting drug development. Hutt discusses the changes in the drug approval process. Over the last two decades the time it takes for a drug to go through the development to approval process has increased from 6 to 8 years to 15 to 16 years. This extension is not due to the approval process itself, but to the requirement for more research and development. Suggestions are made as to how to cut down approval time, and thus cut drug costs. Specific bills addressing drug approval are outlined and compared.^ieng