Politics. Moore Co., TN is dry. Despite being home to the Jack Daniels distillery in Lynchburg you cannot purchase a six-pack at the grocery store. Moore and four other counties in TN, plus several others throughout the south are holdouts from the days before and after Prohibition when statewide bans were common.
So, the current tussle over which states will permit the sale/prescribing of mifepristone is not exactly new. A group of physicians has brought suit in Texas against the Food and Drug Administration asking the judge to, in effect, declare mifepristone’s approval as invalid.
Expecting an adverse decision, 12 attorneys general have initiated a lawsuit to suspend the FDA’s REMS strategy, a condition for widespread access to the drug, including via mail order.
The Supreme Court will be called on to settle the matter eventually. In the meantime, what happens next could look like the gun running days of post-prohibition. States that bar the prescribing and sale of mifepristone will attempt enforcement against telehealth visits and mail-order.
The political risk for the telehealth industry becomes more acute as they will need to balance their internal priorities against the very different attitudes and traditions that characterize the vastness of the American landscape.
Not an enviable situation. Missteps could be costly to the industry as a whole.
Policy. Nothing hates consistency more than politics. Late Friday, the Drug Enforcement Agency proposed changes to prescribing criteria associated with telehealth visits. In effect, the new rules would limit prescriptions that are not preceded by an in-person visit with a physician to 30-day supply of Schedule III, IV and V non-narcotic drugs and/or buprenorphine to address opioid use disorder. Subsequent prescriptions would need to be accompanied by an in-person visit.
The move is in response to shortages of Adderall in recent months. When the free-wheeling telehealth policies of the pandemic met the innovative minds of young adults looking for academic edge, it was no contest. The federal policy apparatus had failed – on several issues – to appreciate the internet as the largest and most effective “how-to” guide ever created.
Telehealth policy is slowly winding its way back to something between “nearly never” to “a valuable modality for an existing patient-physician relationship” unless, of course, we are talking about mifepristone.
Not the worst policy outcome in the long run but in the near term it will be disruptive to the clinically sound operations of the addiction industry. It may also create chaos among the plethora of digital health companies, hellbent on growth, with some devolving into licensed drug pushers.
Power. Because the Texas lawsuit centers on mifepristone, it is widely underappreciated that it takes aim at the FDA’s approval process and has far reaching implications.
The plaintiffs are asking the court to declare FDA approval and labeling in violation of the Food, Drug & Cosmetics Act if the agency fails to rely on clinical studies and investigations.
In effect, a decision for the plaintiffs could – and there are a number of issues, especially related to statute of limitations – limit the recent push into reliance on “Real World Evidence” and the liberal use of Accelerated Approvals.
Ironically, a decision for the plaintiffs which is widely expected, might end up being a positive outcome for the FDA, the underlying political issue notwithstanding.
Under pressure from industry and lacking principled leadership, bad approvals have mounted. From a host of oncology drugs, to Aduhelm to mRNA booster shots, the agency is increasingly the target of ridicule from physicians and researchers. Loss of the public’s trust is nearly irreversible.
A return to the FDA’s roots of objectively scrutinizing data from randomized controlled trials might be a good thing in the end. Hard to see it through the partisan political lens everyone wears these days but objective evidence would be a welcome change.
Have a great rest of your long weekend.
Emily Evans
Managing Director – Health Policy
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