Should FDA get more power over compounding pharmacies?

With meningitis cases stacking up--and the death toll mounting, to 9 over the weekend--the list of questions is growing, too. Do doctors know enough about the source of drugs they inject? Are clinics pinching pennies too zealously? Should patients have been getting steroid injections in their spines in the first place? And, above all, should compounding pharmacies face stepped-up regulation?

The meningitis outbreak has been linked to contaminated methylprednisolone acetate made by New England Compounding, a sizable compounding pharmacy that has since been shut down. The illnesses amount to a confluence of healthcare trends--from drug shortages to reimbursement practices to widespread use of unproven treatments.

As The New York Times points out, generic versions from Teva Pharmaceutical Industries ($TEVA) and Sandoz, the generic unit of Novartis ($NVS), were no longer available. Plus, New England Compounding's version was cheaper than Pfizer's ($PFE) Depo-Medrol brand--$25 per vial, compared with $40 to $46. Medicare and other payers reimbursed a set amount for the injections, about $300, so using a cheaper drug would maximize earnings, the NYT reported. That's certainly not unprecedented; when counterfeit cancer drugs were found in the U.S. drug supply, bargain-shopping clinics bore some of the blame.

Meanwhile, the evidence doesn't support the steroid injections as treatments for spinal pain, experts have said. The data showed "no strong evidence for or against" their use, the Times says. That lack of evidence didn't stop their spread, just as lack of data didn't stem a tide of cardiac stents, when drug treatment might have been equally effective in many of them. And that's just one example.

And then there's the debate over compounding pharmacies, a long and tangled story in itself. FDA has been hands-off, lacking the authority to strictly oversee the drugs made by independent compounding pharmacists. That subset of the industry has been defending itself vociferously over the past several days, pointing out that New England Compounding had run afoul of FDA rules in the past, and that it wasn't certified by the leading association.

The biggest recent battle over compounding revolved around K-V Pharmaceuticals' ($KV.A) preterm-label drug Makena, a branded, standardized version of a hormone injection produced by compounding pharmacies for a small fraction of the cost. FDA said it wouldn't interfere with doctors' prescribing compounded versions, so long as they weren't made in bulk. Whether the meningitis outbreak changes that policy--and prompts Congress to grant FDA more authority over the compounders--remains to be seen.

- read the NYT piece

Suggested Articles

The future may be uncertain for AZ’s Imfinzi in first-line lung cancer, but its targeted med Tagrisso now boasts a green light in that setting.

Ultragenyx is back with another FDA nod, this time for Crysvita to treat X-linked hypophosphatemia in patients one year and older.

Roche got a two pieces of good Hemlibra news early this week—and what's good for Hemlibra must be good for Roche.