Pear in mind: A blog in the public interest

Here in Washington, we can’t agree on much – apparently not even whether it’s in the nation’s interest to investigate the circumstances around a deadly siege of the Capitol. But there does appear to be bipartisan agreement on the need for a commission to conduct a post-mortem of our pandemic response. 

A prime subject for evaluation will be the Emergency Use Authorization (EUA) provision, which permits the Food and Drug Administration to abbreviate its approval process for drugs, vaccines, and devices in order to spirit new products to market in an emergency. I’ve discussed it several times before in this blog, in greatest detail here.

Last week, I penned an opinion piece for Barron’s evaluating the EUA, concluding that the provision’s performance had varied by product class (vaccines: generally good; drugs: subject to political manipulation; devices: often poor). In case you can’t pierce the paywall, there’s always a recent two-day meeting convened by the National Academies of Sciences, Engineering, and Medicine. You can watch my session, also featuring FDA Commissioner nominee Rob Califf, Georgetown University Law Center’s David Vladeck, New York City Health Commissioner David Chokshi, and Patrica Zettler from the Ohio State University School of Law. A summary of the workshop is available here.

We have gotten a lot wrong in this pandemic (and quite a bit right, too), but an honest accounting of our successes and failures will be necessary if we are to prevent future disasters.