Compounders can help relieve drug shortages, says Revelation Pharma’s CEO, but they need help from the FDA. Shawn Hodges was interviewed for the latest edition of Pharmaceutical Executive for a piece called “Drug Shortages May Have a Compounding Solution” where he discussed how 503B pharmacies can fill the gaps caused by commercial pharma shortages and logistics issues.
“If you look at the problem in general, the shortages are being caused by manufacturing problems, supply chain issues, economic factors, and regulatory issues. There are opportunities in certain instances where compounding pharmacies can fill the void until the manufacturers are able to produce the products.”
Shawn is just one of the amazing team members at Revelation Pharma, which isn't surprising — Revelation is officially a Great Place to Work!
But, he pointed out, “For that to happen […] that would require some regulatory changes” from the FDA. Simple changes, in fact, like getting information from drug manufacturers about shortages in real time so compounders can step in before patients feel the crunch.
“Right now, there is a lag if a drug goes on shortage,” he explained. “Sometimes there is a disconnect from reporting from the manufacturer to FDA, and then in turn from FDA to all the stakeholders, whether it be hospitals or other supply chain users.” That disconnect means patients and providers can be left scrambling for lifesaving drugs before compounding pharmacies can pivot to address them.
Sometimes those reports can take as long as six months. A few years ago, a tornado took out a Pfizer plant and it took six months for FDA to report the resulting drug shortages.
We’re thrilled not only that Shawn is helping get the word out about how compounding pharmacies can be a critical stopgap, but how Shawn — and Revelation Pharma in general — is becoming a go-to source for expert opinion on the subject. Nice job, Shawn!
