Editor's Note: This is a complimentary research note published by Healthcare Policy analyst Emily Evans. CLICK HERE to get COVID-19 analysis and alerts from our research team and access our related webcasts.
While cleaning out the regulatory inbox Wednesday, the new administration withdrew a rule for one of the most vexing political and health policy problems: CBD regulation. The FDA currently regulates CBD as a pharmaceutical.
$GWPH’s Epidiolex is indicated for treatment of epilepsy, among other things. The 2018 Farm Bill de-scheduled CBD, a move championed by then Senate Majority Leader Mitch McConnell, but, at the insistence of other Senators, deferred to the FDA for regulation.
Then the trouble started.
Because CBD has been wrapped up with marijuana as a controlled substance, there is little scientifically developed evidence on important issues like therapeutic benefit, dosage toxicity and use in vulnerable populations. The absence of information on safety and efficacy would seem to rule out FDA approval through the food supplement pathway, leaving regulation as a drug the only viable regime.
However, the FDA had suggested there may be a legal route to create a separate approval process that is neither drug nor food. They provided few details, however.
The Biden administration’s withdrawal of the CDB guidance, which took 18 months to develop could mean several things. First, it seems likely that the administration wants to buy time and lower expectations that CBD regulation will be a top priority.
Senate Republicans made several derisive comments about the House’s use of time on the MORE Act, suggesting 2024 aspirants like Tom Cotton (R-AR) might target similar messaging down Pennsylvania Avenue.
Another possibility is that, with Sen. McConnell relegated to the minority, the pressure to resolve the regulatory quagmire has abated. Leaving the rule pending at OMB only invites unwanted political pressure when there are more pressing matters to consider.
Of course, it could also be that the Biden administration simply does not like the guidance the FDA developed. Withdrawing the rule, provides them with another opportunity to open the process for comment and consider any new evidence that may have developed since CBD was de-scheduled and disconnected from marijuana.
Regardless of the reasons, the withdrawal represents another delay in developing consistent national regulations.
Wednesday, Acting Secretary of HHS, Norris Cochran notified America’s governors that the Public Health Emergency that expired Jan. 21 had been extended 90 days. He went on to say that he fully expected the PHE to remain on the books through the end of 2021.
When the PHE is to be terminated or allowed to expire, Cochran promised states would be given 60 days advance notice.
Knowing government as we do, federal emergency declarations can persist after the threat is gone. The H1N1 pandemic lasted from April 2009 to April 2010. An emergency was declared by President Obama in October 2009 and suspended in October 2010.
H1N1, of course, is highly contagious like SARS-CoV-2. The CDC estimates that around 60 million people were infected. Unlike H1N1, SARS-CoV-2 produces a much more serious disease. The CDC estimates about 12,000 people died from complications associated with H1N1. The current estimate for COVID-19 is 412,000.
Because of the seriousness of COVID-19, the necessary public health response has poured hundreds of billions of dollars into surveillance, diagnosis and treatment. These funds have taken the form of direct grants to states, a 6.2% increase in the federal match for Medicaid expenditures and waivers of Medicare rules on everything from cost-sharing to coverage requirements.
Taking that needle out of states’ arms, not to mention the health care system’s, will not be quick or easy.
Finally, H1N1 never took on the trappings of religion. It will be more difficult, then, to declare COVID-19, with its symbols, rituals and hellfire damnation for those who don’t properly venerate its icons, “over.”
The PHE has taken an attitude of permanence that, while expensive, is ushering a new era for health care that makes the ACA look like a piker.
The inauguration safely behind him and the National Guard called home, President Biden begins the job of governing.
He does so using one of the most time-honored techniques in politics: shift as much responsibility for the current condition of ___________ [fill in the blank: economy, foreign relations, pandemic] to your predecessor, especially if he/she hails from an opposing party.
Often referred to as the “honeymoon” the value of this strategy is it buys time and cooperation on initiatives great and small.
Using that playbook, the Biden administration spent much of the week asserting the current vaccine state of affairs was failure. Interestingly, there was less cooperation with this talking point than expected.
The new health policy press corps, reassigned from politics a year ago, pointed out that the U.S. had been vaccinating about 1 million people a day before Biden entered the White House, making the new president’s goal of 100 million doses in 100 days a low target.
By Sunday, Chief of Staff Ronald Klain acknowledged a lot of work had been done before Jan. 20, 2021.
It is a small misstep – it would have been better to say nothing at all – but it means that all the Biden administration has riding on attenuating the crisis, from enhanced unemployment benefits to state and local aid to rental and mortgage assistance may bump into the hard realities of scientific advancement.
Further exacerbating the effects of widespread vaccination is the ebbing of the pandemic itself. Case peak in the U.S. appears to have occurred about Jan. 11. By April 30, if the pattern of the last year holds and no new variants emerge that confound immunogenicity, the COVID-19 crisis should be in the rearview mirror.
If that is the case, Biden will not be able to buy as much time as he had hoped and the cooperation he may have counted on may not be there.