Speed up the FDA’s vaccine-approval process [full text of WaPo opinion piece]

It seems some users will not be able to see the opinion piece I wrote with Ted Bailey on the WaPo site because of the Washington Post’s paywall. Here is the full text:

Speed up the FDA’s vaccine-approval process

By Eric. E Johnson and Theodore C. Bailey

With the coronavirus pandemic, our challenge is to move faster than a very fast-moving problem. Changing the law could help.

The estimated 12-to-18-month timeframe for getting a vaccine to market is largely because of safety and efficacy testing required by the Food and Drug Administration. Legislation could shorten that timeframe without compromising the science — if the testing process tolerates more risk on volunteer study participants.

The FDA’s long-standing approval process places a premium on keeping human subjects safe. For most problems, this represents a prudent calibration of risks and benefits. For the coronavirus, however, the tradeoffs are different. The general public faces imminent danger from a virus capable of exponential growth.

Over the years, Congress has repeatedly, and rightly, stepped in with legislation to speed the process. Now, Congress should act to sharpen the curve of innovation against covid-19 by pushing the FDA to suspend its rules and practices and navigate according to the judgment of its experts.

Regular FDA approval processes begin human testing with a phase-one trial that must run its course with a small number of subjects — studying safety before enrolling subjects for larger phase-two and phase-three trials to assess a vaccine’s effectiveness. Yet clinical trial phases that are typically sequential could be combined or overlapped.

Collapsing trial phases without compromising scientific standards will require exposing more individuals to uncertain risk. Yet to do otherwise in a rapidly expanding pandemic leaves the global population exposed to a bureaucratically protracted period of pandemic risk without medical mitigation.

In the current crisis, it is ethically defensible to expedite clinical research with the cooperation of well-informed and consenting clinical subjects. There is no “safe” choice; it’s a risk-risk tradeoff — a question of more risk for research subjects or a longer wait for an approved vaccine.

We should respect the will of selfless individuals to knowingly take on the risks of investigational vaccines as an act of service for the sake of ending the pandemic.

Eric. E Johnson is an associate professor of law at University of Oklahoma College of Law. Theodore C. Bailey is chief of the Division of Infectious Disease at Greater Baltimore Medical Center.

My op-ed with Dr. Ted Bailey in the Washington Post on speeding up vaccine approvals

Dr. Theodore Bailey of Greater Baltimore Medical Center and I argue in a Washington Post opinion piece published today that one way the law can help end the pandemic is by speeding up the vaccine approval process at the FDA.

My new paper co-authored with Dr. Ted Bailey: Urgent Legal Lessons From a Very Fast Problem: COVID-19

I co-authored a short paper about the law and the coronavirus pandemic with Dr. Theodore C. Bailey, who is chief of infectious disease at Greater Baltimore Medical Center. It is forthcoming in the Stanford Law Review Online. The pre-print is available now on SSRN.

Here is the abstract:

“The course of a pandemic is dictated not just by biology, but also by law. And crucially, unlike biology, law can be readily adapted in response to a pandemic. Unfortunately, the current law does not take account of the compressed timeframe and rapidly changing social needs that distinguish pandemic times from normal times. We thus suggest three urgent, early lessons for law in the pandemic context: First, free information flows save lives, an observation which has ramifications for freedom of speech and press, copyright law, and patent law. Identifying particular hazards that patent law poses to the free flow of scientific research findings, we suggest a government-funded reward system as an adjunct to the patent system to incentivize pandemic-relevant research and its rapid publication. Second, politically accountable decisionmakers may not act optimally to save lives. We suggest a refashioned, politically insulated U.S. Public Health Service imbued with administrative independence in the vein of the Federal Reserve Board. Third, pre-crisis regulatory structures are not proving nimble enough in the midst of the pandemic. We suggest legislation that directs the FDA to be creative in designing case-by-case approval procedures for vaccines and other treatments to allow them to get to market much faster. To accelerate approvals while retaining scientific rigor, we suggest allowing well-informed, consenting human testing subjects to take on more uncertain risk than the FDA currently tolerates. In sum, we argue for a more general, systematic, and critical perspective on law in the special context of a pandemic.”

by Eric E. Johnson

FDA launches Coronavirus Treatment Acceleration Program

Yesterday the U.S. Food and Drug Administration launched what it’s calling the Coronavirus Treatment Acceleration Program (CTAP), which it describes as “a special emergency program for possible therapies” that “uses every available method to move new treatments to patients as quickly as possible, while at the same time finding out whether they are helpful or harmful.”

This seems like a very positive step.

Based on the information the FDA has provided, CTAP at this point seems to be mostly about FDA doing its work more rapidly rather than differently. The information released yesterday describes “ultra-rapid, interactive input on most development plans” and “ultra-rapid protocol review.”

Along with the information release about CTAP, the FDA is reporting 10 “therapeutic agents” that are currently in active trials, plus 15 more in planning stages.

by Eric E. Johnson
published April 1, 2020