The FDA can finally implement that big compounding law … nearly six years later

The FDA prevailed last week in a key lawsuit over its compounding rules. The dispute was over when a compounder can make a product using bulk powder. That might seem dull, but trust me, it's not: It’s a dispute that cuts to the heart of the compounding rules written by Congress after the 2012 fungal meningitis outbreak caused by compounded drugs, which killed 76. And on Thursday, D.C. District District Court Judge Amit Mehta upheld the FDA’s existing rules on the issue. 

For more on the case, my colleague Ed Silverman has the dispatch for STAT. But as a compounding nerd, I can’t help including a bit more color here: FDA’s policy on bulk powder has been a pain in the agency’s side for years now. In the nearly six years since Congress passed the compounding law, the agency has only come up with rules about using bulks for two out of roughly 250 substances being evaluated. Compounding experts attribute that delay, at least partially, to the controversy that has surrounded the policy being weighed in this court case.

This ruling (assuming it isn’t overturned in a presumed appeal) finally gives the agency legal cover to march ahead with its preferred policy.

“It is likely that the agency will significantly speed up its clinical need evaluations over the coming weeks and months,” said Eli Tomar, counsel at Akin Gump, who represents compounders that work with FDA-approved drugs rather than bulk drug substances.