FDA Director Encourages Collaboration To Solve Supply Chain Challenges
“We want to work together with HIDA and with all of you
to move the device shortages space forward,” FDA Director
of Emergency Preparedness/Operations and Medical
Countermeasures Julia Marders, MS, RN, told Washington
Summit attendees. “We recognize that the importance of preparedness
and prevention of shortages means working
together.”
Marders thanked medical supply distributors for their
preparedness knowledge and guidance to help navigate
planning for future hurricane seasons. The FDA “really
recognized” that manufacturers and distributors have made a concerted effort to be even more prepared for hurricane
seasons, she said. Marders commended the industry
for its impressive contingency plans “whether it
involved moving manufacturing to another plant outside
of the U.S. or moving product outside of the impact zone
prior to the storm hitting.” She added that preparations
such as generators and adequate fuel supply along with
proactive strategies for returning to impact zones and
getting product moving again after a storm were also
keys to success.
She also told attendees that the FDA would like to see
device shortages legislation similar to rules governing
the pharmaceutical industry requiring drug manufacturers
to notify the agency of an actual shortage situation.
“We really recognize the importance of being
notified ahead of time – right now we rely on voluntary
information from manufacturers and that puts us in a
pickle when it comes to being prepared.”
Executive Briefing | September/October 2019