In hopes of alleviating potential drug shortages and other issues wrought by the coronavirus pandemic, the Food and Drug Administration drastically rolled back its oversight of compounding pharmacies — a swift and sweeping relaxing of the rules that were put in place after a fungal meningitis outbreak traced to one such center killed more than 60 and sickened over 700.
Public health experts say there’s merit to relaxing the rules amid the pandemic, but they’re already cautioning that there’s no reason to make the changes permanent. Compounders, meanwhile, are gearing up for a fight to do just that.
It’s the latest twist in a long-running fight that cuts to the central question of whether the FDA should have any meaningful oversight of this controversial industry. And it’s just the latest example of the pressure on the FDA under President Trump to rollback regulations meant to protect public health.
About the Author Reprints
One would have thought that the FDA’s laissez-faire approach toward allowing “emergency use” diagnostic tests for detecting antibodies to COVID 19 would have taught all of us a lesson. Apparently not. But the tests are for in vitro use. Should those same dubious practices apply to in vivo products as well?