There are number of conflated regulatory problems in this piece:
1) FDA needs to move its data ingestion into the 21st century (note: large industry can be as resistant to changing current process as bureaucracy). In no rational universe should we have to mail data in 2020
2) In vitro diagnostic regulation is a mess and needs to be revamped top to bottom. Either exempt all Lab Developed Tests, rewrite the law to make them all subject to oversight, or come up with a 3rd path.
3) Emergency Use Authorization needs to be rethought with the ability for either political leadership or FDA to have broad capability to expand the category of what gets covered
With respect to point #2, the real reason why revamping any regulatory regime "top to bottom" is difficult is because so much organizational, legislative, and administrative cruft has built up over the years in the federal government that means no one individual has the authority to drive reform. See FDA's discussion paper from Jan 2017 on revamping the LDT regulatory regime (https://www.fda.gov/media/102367/download) for more on the inane complexity created by the federal bureaucracy: "For example, a test made by a conventional IVD manufacturer would be regulated by FDA initially. If a laboratory made a significant modification to that test, it would then be regulated by CMS. If the original manufacturer then made another significant modification, the modification would be regulated by FDA."
Also: "In 2015, FDA established an Interagency Task Force on LDT Quality Requirements with CMS, the Center for Disease Control and Prevention, and the National Institutes of Health"
Any manager worth his/her salt can tell you that a task force involving four different agencies is unlikely to ever result in any meaningful change. A cornerstone of effective management is to designate one person who is responsible for execution and hold them accountable. This is exactly how the executive branch, from the president on down, is supposed to function (with oversight from the judicial and legislative branches, of course), but few parts of it are like that after centuries of bolting on overlapping agencies and departments.
I don't think "conflated" is the right word. Romer doesn't imply that these problems have the same cause, or are even correlated (although I suspect they are).
He just lays them out as stark examples of FDA getting in the way of the public interest in this pandemic.
Thing about these problems (and others) is that bottle necks and red tape generally are problems in just about any country.
Political leadership in this situation involves noting the regulatory and bureaucratic hurdles to action and using your authority to supersede them when a pressing situation requires it. Someone has to sit down and say "what needs to happen, what's standing in its way? What orders have to be issue to stop this today?" Someone has to say "this priority is more important than anything else at this point", etc. Just as an example, it shouldn't be hard to notice tests are only being mailed and to stop that this case, etc.
A crisis always requires political leadership because of both the this bureaucracy and the general confusion created by crisis. Many if not all bureaucracy will act ineffectively by default unless someone forces their hand.
Which is to say that the current situation is an abject failure of leadership specifically.
It's not a matter of overriding everything or nothing. Any crisis is going to involve some level of standard operating procedures not working, even with the best planning (though the US through out planning beforehand). Effective action requires a chain of events all happening and some central institution has to look at the process as a whole because 9 out of 10 things happening well can easily not be enough.
In no rational universe should we have to mail data in 2020
I remember a study where the lab reports were printed on there own printer. The FedEx employee showed up with a labeled box, put the huge stack in it, and left. I think that daily stack of labs cost somewhere in the five figure range each day.
Agreed on the conflation, and clearly there are many parts of the FDA that need attention. However this article is misleading because it focuses heavily on one teams (basically then Seattle Flu Study) of extremely competent people hamstrung by onerous requirements. It ignores the many more incompetent people stopped by more scrutiny and the errors that low scrutiny produce.
As an example for the latter I point to antibody tests, many of which were given approval despite being poorly validated (1). These cause at least as much harm as good.
The FDA needs to improve and we need to remove some counterproductive regulatory steps (when the emergency was declared, in some ways it got harder to approve a test under EUA, that should be adjusted). But lets remember that hasty decisions in medicine can cost lives (see thalidomide, which the FDA mostly dodged unlike Europe, or Viox). We shouldn’t make broad decisions on examples cherry picked from the best case scenarios.
> 1) FDA needs to move its data ingestion into the 21st century (note: large industry can be as resistant to changing current process as bureaucracy). In no rational universe should we have to mail data in 2020
I find it fascinating that the FDA wants data in SAS 5 transport files [1][2], a file format with very obvious mainframe heritage – 80 byte records and floating point values in IBM hexadecimal floating point instead of IEEE [3].
1) FDA needs to move its data ingestion into the 21st century (note: large industry can be as resistant to changing current process as bureaucracy). In no rational universe should we have to mail data in 2020
2) In vitro diagnostic regulation is a mess and needs to be revamped top to bottom. Either exempt all Lab Developed Tests, rewrite the law to make them all subject to oversight, or come up with a 3rd path.
3) Emergency Use Authorization needs to be rethought with the ability for either political leadership or FDA to have broad capability to expand the category of what gets covered