It’s clear that the Food and Drug Administration (FDA) should have more compounding pharmacy oversight, but how long will it take them to make other important decisions on public health?

The recent news is troubling.

For example, a shipment of tainted steroid from a Massachusetts-based compounding pharmacy was linked to the recent U.S. meningitis outbreak. According to state and federal records, it took the FDA approximately 684 days to issue a warning letter that may have saved lives and time. Usually it should only take 90 days for the compliance branch, local district directors to decide on a firm’s regulatory outcome. The FDA mandates a strict response time—15 days—for an audited company to reply after a 483 is issued. The FDA should also be held to a 60- or 90-day turnaround.

As a former FDA inspector, I’ve been there. Some of the cases I was involved with took 24 months to get a final warning letter decision. This is unacceptable because there is a six-month follow-up that should be conducted.

 …