Cell Therapy Enforcement Discretion Ending, But US FDA Still Faces Challenge Going After Bad Actors
Planned 31 May revocation of enforcement discretion for certain cell therapy products without IND or BLA is important, but experts say the FDA’s next moves are what will really shape the field and patient safety moving forward.
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US FDA is frustrated that few stem cell therapy makers are seeking regulatory approval of their products during the current enforcement grace period.
Near tie goes to the US FDA? While almost every member of the Arthritis Advisory Committee agreed with agency’s assessment that ChemoCentryx’s trial of avacopan for ANCA vasculitis was poorly designed, making it hard to tease out the drug’s benefit-risk profile, about half were in favor of approval due to the potential to spare patients from the adverse effects of steroids. Others said the sponsor didn’t meet the agency’s standard for approval off just one pivotal study.
Drug manufacturers still have a variety of ways to limit the impact of the Biden administration’s historic decision. Whether the huge political loss for industry translates into more than just headline-risk or faster global COVID vaccination remains to be seen. It's also not clear whether it’s an ominous sign for other industry battles in the US, including the drug pricing debate.