Virtual Reality – FDA and AdComms

Vaccination has been robust. Cities are opening up. Plans are underway for back-to-school. Travel is robust. Offices are cautiously re-opening. There are multiple hallmarks that, whatever the consequences, we are going back to normal. The age of COVID-19 will likely continue, but with the emergence of a significant proportion of the population with vaccines pumped into them, we headed back on almost every level. Not FDA.

Today the FDA announced an upcoming meeting of the Cardiovascular and Renal Drugs Advisory Committee set for July 15 and once again, it is slated to be virtual. As the rest of the country prepares for Return to Travel, Return to Work, Return to School, this raises the question of “when” FDA is going to get off the virtual dime and migrate back to in-person meetings? One has to think that is is highly likely that nearly all people who attend an FDA Advisory Committee meeting as members are going to be vaccinated individuals. And that while travel might be required, CDC has stated that vaccinated persons “who are fully vaccinated with an FDA-authorized vaccine of a vaccine authorized for emergency use by the World Health Organization can travel safely within the United States.”

At a time when almost everyone is returning – at least partially – to pre-COVID patterns – what signal does it send when the agency responsible for approving the vaccines many of us just took is not? One branch of Health and Human Services (HHS) – the CDC has said – albeit in uncertain fashion and with an indelicate process – that masking is no longer necessary for the vaccinated while another HHS agency stays virtual.

As anyone who has had to sit through the misery of a virtual FDA Advisory Committee meeting can attest, and as recently noted on this blog, there is a significant amount of wasted time and inefficiency with an e-meeting over the old fashioned in-person variety, not to mention pain for those of us having to endure it. Moreover, while virtual platforms (when they work) have been a lifesaving substitute – from telemedicine to online cocktail parties – they lack the important nuances of human interaction as well as that je ne sais quoi that adds quality to the experience.

Also noteworthy, application has been made for full approval by one manufacturer for the COVID-19 vaccine and another will soon follow suit. Presumably there will be an advisory committee meeting associated with those applications – one that might be soon given that the application is a Priority Review. One has to consider that an advisory committee meeting for that deliberation would certainly raise some eyebrows if not held in person. It would be ironic to say the least.

FDA appears to be swimming outside the current. Perhaps there are policy and logistical questions to consider. Thinning out the seating pattern might be one – requiring people to produce evidence of vaccinated status might be another. But the world is moving on. Hey there FDA, think about the optics if nothing else. Let’s get together again.

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