The FDA’s extraordinary move
Due to COVID-19-related drug shortages, the FDA has taken the extraordinary step of temporarily allowing hospitals to purchase hard-to-find drugs from compounding pharmacies to treat patients hospitalized with severe COVID-19. The FDA warns that this decision is a temporary measure during an emergency and will remain in effect as long as hospitals experience shortages of key drugs.
The FDA also attached a number of additional conditions to its decision. For example, in order for a healthcare facility to order the drug from a compounding pharmacy, it must be included in the FDA’s list of drugs in short supply. In addition, the hospital must have exhausted all available options to gain access to a commercial version of the drug;
But even so, the FDA’s release is a big step toward reconciliation with its longtime foe: manufacturing pharmacies.
The FDA and compounding pharmacies are implacable enemies
The war between the FDA and compounding pharmacies over extemporaneous drugs, which are essentially generic copies of registered and commercially available drugs, began in 2012, following the high-profile scandal of a steroid that caused a deadly outbreak of fungal meningitis that was manufactured at the New England Center for Extemporaneous Formulation.
As a result of a long battle with manufacturing pharmacies, in 2016 they were banned from manufacturing analogs of FDA-approved drugs simply to lower their price. The exceptions were those manufacturing centers that were licensed as “outsourcing facilities,” pledging to adhere to stricter quality standards, and in particular, to adhere to the cGMP standard. However, they were also allowed to create their own versions of brand-name drugs only in the event of shortages or discontinuation. And manufacturing pharmacies were allowed to produce drugs only on a customized basis, for example, if a particular patient needed to change the dose of a drug.
Reconciliation in the face of scarcity
Typically, the FDA attempts to address drug shortages by working through the global pharmaceutical supply chain without relying on extemporaneous compounding. However, the COVID-19 pandemic has forced the organization to change its principles and recognize the value of compounding pharmacies in the face of severe drug shortages.
The FDA recently issued update on the shortage of anesthetics, citing increased demand. And the U.S. Drug Enforcement Agency (DEA) in turn said that due to the COVID-19 pandemic, allow increased production and imports of midazolam, as well as certain other painkillers and sedatives, including fentanyl, ketamine, phenobarbital, and diazepam.
Shutterstock/FOTODOM UKRAINE photos were used
