PhRMA concerned with state right-to-try bills

The Pharmaceutical Research and Manufacturers of America said it has "serious concerns" with state right-to-try bills. The group said completion of clinical trials is necessary to show a medicine's safety and efficacy and said expanded access programs are an option for patients who are ineligible or unable to participate in trials. PhRMA said state legislation "is unlikely to add any meaningful new approaches that can optimize the federal expanded access process." The Biotechnology Industry Organization said it is reviewing right-to-try bills to understand how they interact with federal regulations for expanded access programs.

Earlier this month, Neuralstem Inc. (NYSE-M:CUR) said it would use Colorado's right-to-try law to offer patients access to an experimental human neural stem cell (hNSC) therapy ( NSI-566) to treat amyotrophic lateral sclerosis (see BioCentury Extra, June 5). ...