How the Covid-19 pandemic has reignited one of the fiercest FDA debates

In recent weeks, the FDA has issued a number of temporary policies that seriously deregulate drug compounders, the pharmacies that make drugs outside of traditional factories, often in smaller batches. The move is meant to help avoid supply shortages for critical drugs like morphine that are used to treat Covid-19 patients.

The changes are striking: they include relaxing cleanroom standards, waiving tests meant to make sure drugs don’t degrade on shelves, and vastly increasing the number of pharmacies that can make these drugs freely, and largely without FDA oversight.

It’s a welcomed change for compounders, which have groused about the FDA’s approach toward the industry since Congress empowered the agency to crack down after a 2012 fungal meningitis outbreak caused by compounded drugs killed nearly 70. Now, compounders are pushing to make the policies permanent. Early signs show the FDA will resist that push, but you can bet compounders are going to fight tooth and nail on this issue: this is the same industry that once urged congressional appropriators to withhold some of the FDA’s funding until it reversed course on these very issues. (Appropriators resisted those calls, of course.)

For more on the fight to come, check out my new story for STAT here.