Pharma Blog Watch

Balancing Increased Access with Sound Trials (Pharma's Cutting Edge)
In his blog, Fred Cohen discusses the FDA's proposed rule to expand access to investigational drugs to critically ill patients. "It's a tough problem. Too much weight given to the needs of ill patients can jeopardize completion of the investigational program."

"In the proposed rule, FDA keeps the older terminology (but clarifies its meaning) and adds two new expanded access protocols aimed at addressing the needs of individual patients and intermediate-sized (~10 to ~100) patient populations, respectively," he writes. "Individual physicians will still have to work with sponsors and collect drug disposition and adverse event data, but cooperative sponsors can include treatment protocols for individual patients in an amendment to their existing [protocol]."

"Overall, I think both sponsors and patient advocates should be pleased with these new rules."