Whistleblower News & Articles
October 14, 2019
In a recent episode of Last Week Tonight, John Oliver explained drug compounding pharmacies and highlighted some of the problems they pose for regulators and the public.
Drug compounders make medicine for people (and animals) whose medical needs cannot be met with FDA-approved products. Instead of obtaining drugs mass-produced by a pharmaceutical company, a patient can turn to a compounding pharmacy for custom-made medication.
Compounding pharmacies allow medication to be tailored to the specific needs of a patient. For example, they can prepare medication in a liquid form for persons who cannot swallow pills or produce medicine in lower concentrations than what’s commercially available. Oliver used the example of a parrot, which would need compounded medicine because drugs are not manufactured in dosages for birds.
Being able to turn to drug compounders for custom-made medication is helpful and necessary. As we have noted previously, however, compounding pharmacies are far less regulated than are pharmaceutical companies manufacturing FDA-approved drugs.
Oliver discussed, with his characteristic dark humor, some of the problems that have arisen with compounding pharmacies.
In response to the NECC disaster, Congress passed the Drug Quality and Security Act, which – among other things – created a category of drug compounders known as “outsourcing facilities.” Such facilities are subject to regulation by the FDA and stricter scrutiny than are small retail pharmacies. As Oliver notes (and as we have written about previously), registration as an outsourcing facility is voluntary.
Oliver reports that, to date, only 77 compounders have registered as outsourcing facilities while others carry on as before and are subject to regulation only by under-staffed state agencies. We agree with him that drug compounders should be regulated more closely. If you become aware of fraudulent or unsafe practices, we encourage you to contact us.