Politics. There are a couple of conclusions to be drawn from last week’s Democratic convention. The first of those is that conventions are absolutely NOT meant to be virtual. The second conclusion is that Democrats are putting a lot of eggs in the COVID-19 basket.
It might be the right strategy. The Trump administration’s response has been filled with unforced errors and some of the worst public health communication since the bubonic plague. Many times since March, the president, one to the weakest orators to occupy the Oval Office since Silent Cal Coolidge, has had trouble summoning the right tone and precise vocabulary to communicate progress in battling the pandemic.
Politics hates a vacuum and into the white space created by the Trump administration has rushed a narrative that was repeated dozens of times during the convention; the response was botched; the economy is in shambles and Joe Biden will fix it all. In order for that narrative to be sustained up until Nov. 4, the response needs to remain ineffective and the economy must continue to be a wreck.
The question is: Will it?
Without a doubt the initial White House response to the COVID-19 outbreak was hesitant. The mobilization that followed, however, was effective in adding necessary health care capacity and restructuring a severely compromised supply chain. Since then, the asymptomatic outbreaks in the south and west, a direct result of a confused public health message, went undetected for too long. The administration made up for that with interventions, particularly in agricultural states like Alabama, Tennessee and North Carolina that effectively reversed outbreak trends.
The administration’s decision to permit clinical trials during a pandemic, a departure from policy at NIH and the Food and Drug Administration, has produced a more uniformly positive result. Hydroxychloroquine debate notwithstanding, the American health care industry has produced three therapeutic responses with varying indications and effectiveness: Remdesivir, steroids and, as of this afternoon, convalescent plasma. A fourth therapy, monoclonal antibody is showing promise and expected to be available shortly.
The combined effects of public health interventions, particularly in the high risk congregate living setting, advances in therapeutic responses, a better understanding of the disease progression and risk factors and the all-important self-regulation of the uninfected means that all cause, excess mortality reported by the Centers for Disease Control and Prevention since the first week of June has been less than half of that in the 10 weeks beginning at the end of March.
If the trend holds or improves, confirmed case volumes will continue to drop along with hospitalization and deaths. Assuming September and October look more like May than July, the need for Joe Biden to fix the federal response to COVID-19 will look a lot less pressing and perhaps unnecessary.
Economic problems are unlikely to be resolved as easily but in one crucial respect they will follow COVID as it recedes. Interstate and international travel have been severely limited by national and state level quarantines and entry restrictions.
The now widely accepted standard for lifting travel bans and quarantines is 10 cases per 100,000 population. The U.S. is currently confirming 15 cases per 100,000 population. When daily cases drop to about 30,000 international travel bans are likely to be lifted, if not for the purposes of international cooperation then under pressure from the airline and tourism industries.
It won’t be enough to patch the gaping hole created by the last six months but if the pattern we observed in May and June repeats itself, there should be some release of pent-up demand that is received as a positive economic news.
One scenario for September and October that seems achievable is that SARS-CoV-2 infection abates, disease spread subsides while economic activity increases. While all of those things are great for American, none of them are good for Joe Biden, which is what happens when you put too many eggs in your COVID basket.
Policy. Last week the administration quietly announced through a website posting that the FDA would no longer require pre-market approval of Laboratory Developed Tests, putting to end, at least for now, to a debate that has raged for over a decade.
Laboratory Developed Tests are those that are designed, manufactured and used by a single laboratory. Most genetic tests like those performed by MYGN and NVTA are LDTs.
The FDA has asserted since about 2006 that it had the authority to regulatory LDTs but has used “enforcement discretion” in determining which tests, if any, it would review. The “will they or won’t they?” regulatory environment has had some significant consequences. A rapid LDT for Zika was forced off the market in 2016 when the FDA determined the test was so significant that pre-market review was necessary. The uncertainty around similar enforcement of a COVID-19 test led to delays early in the outbreak and from which it took months to recover.
The elimination of FDA oversight of LDTs means any laboratory that meets CMS’s standards can perform these tests. While certainly consistent with the president’s deregulation agenda, the move also frees the COVID-19 testing program from its dependency on DGX and LH. In mid to late July, DGX was taking up to 14 days to complete tests as the company placed a priority on testing for employers and universities, according to reports from the COVID-19 task force. The president apparently was not pleased.
The end of FDA’s enforcement discretion posture, assuming it extends to all LDTs, means the wild west that is genetic testing will continue unless and until a change is made. The competition will continue to be fierce.
Power. HHS’s decision to reverse the FDA’s assertion of regulatory authority over LDTs was announced shortly before President Trump’s Tweeted claims Saturday morning that the “deep state’ at the FDA was hindering the process of enrolling people in trials for SARS-CoV-2 vaccines. That move was following today by a news conference at which the FDA and the president announced an Emergency Use Authorization for convalescent plasma as a therapeutic for COVID-19, even after some government scientists urged caution due to weak data.
While we recognize these actions as typical of our mercurial president and his chaotic decision making, they should also be understood for what they are: a very intense turf between HHS and the FDA. Also in play is an age-old conflict between the slow pace of scientific discovery and the political and economic imperatives of the country and, this being an election year, of President Trump.
It is hard, perhaps impossible, to recall a time when HHS overruled the FDA on anything, let alone their regulatory purview. The FDA is funded largely through user fees and, as a result, has enjoyed a tremendous amount of autonomy as well as a very congenial relationship with congressional overlords – not a great combination for a president in need of a vaccine.
Given the unprecedent move by HHS, we suspect the message was received loud and clear at the FDA.
Emily Evans
Managing Director – Health Policy
