Confusing Communications, Shifting Guidance and Decision Paralysis are Behavioral Norms at the FDA

U.S. health authorities are rightly focused on vaccination as the primary tool to end the Covid-19 pandemic.  However, another “critical tool,” widely used in other developed countries, is “expensive and hard to find” in the U.S., according to ProPublica.  That news outlet is reporting that development and distribution of rapid Covid tests, which should by now be ubiquitous and inexpensive, has been crippled by “an arbitrary, opaque [FDA regulatory] process that meanders on, sometimes long after . . . products have been approved in other countries.”

For those interested in tobacco issues, it is worth noting that ProPublica’s points about FDA treatment of Covid tests and testing companies mirrors the arbitrary and capricious treatment of e-cigarettes and vaping companies.  Following are some examples that will resonate with the vaping community.

1. “In late May, [biotech company] WHPM got a confusing email from its FDA reviewer asking for information that had in fact already been provided. WHPM responded within two days. Months passed. In September, after a bit more back and forth, the FDA wrote to say it had identified other deficiencies and wouldn’t review the rest of the application. Even if WHPM fixed the issues, the application would be ‘deprioritized,’ or moved to the back of the line.

“‘We spent our own million dollars developing this thing, at their encouragement, and then they just treat you like a criminal,’ said [WHPM head of international sales Chris] Patterson.”

2. “Nanōmix, a diagnostics designer based in Emeryville, California, developed a rapid test with the help of a federal grant and submitted it to the FDA in February. In early June, an FDA reviewer sent back a list of questions, giving Nanōmix a deadline of 48 hours to respond. The company couldn’t provide answers that quickly, so it was sent to the back of the line.

“‘We start development on a set of guidance,’ said Nanōmix CEO David Ludvigson. ‘Then they change the guidance after we’re done, and expect us to have conformed to their revised guidance.’”

3. “The FDA reviewer who quit this May described what the delays looked like from the inside. With a background in virology, he could evaluate the hundreds of pages in an application within a few days. But then, something strange happened: The applications would go nowhere for months as higher-up officials seemed paralyzed by indecision.

“‘I could easily process dozens of them, but I ended up with one or two in my queue constantly. They would stay there forever,’ he said. ‘I had a lot of free time.’”

I don’t doubt that much of the FDA’s opposition to smoke-free products is driven by the federal government’s obsession with a “tobacco-free society”, however, the vaping community should find some solace in the fact that confusing communications, “criminal” treatment, shifting guidance, and decision paralysis are cultural and behavioral norms at this federal regulatory agency.

 

 

 

FDA and CDC’s Irresponsible Covid-19 Actions and Inactions

Long after today’s Covid-19 crisis, Americans will remember the catastrophic failures of the Centers for Disease Control and Prevention, and the Food and Drug Administration, the two federal agencies tasked with protecting public health.

Covid-19 infections were first reported in Washington State in late January, virtually at the same time as in South Korea.  According to a detailed timeline, that country immediately “pursued a trace, test, and treat strategy that identifies and isolates those infected with the coronavirus while allowing healthy people to go about their normal lives…the U.S. lost six crucial weeks because regulators stuck to rigid regulations…” which “proved disastrous in a pandemic.”  A Reuters headline put it succinctly: “…Korea trounced U.S. in [a] race to test people for coronavirus.”

John P.A. Ioannidis, professor of medicine, epidemiology and population health at Stanford University, opined: “Covid-19 has been called a once-in-a-century pandemic. But it may also be a once-in-a-century evidence fiasco.”  He noted that as a consequence of the testing disaster, officials have been required to institute draconian countermeasures, including extreme social distancing and lockdowns.  “But,” he observes, “with lockdowns of months, if not years, life largely stops, short-term and long-term consequences are entirely unknown, and billions, not just millions, of lives may be eventually at stake.  If we decide to jump off the cliff, we need some data to inform us about the rationale of such an action and the chances of landing somewhere safe.”

Bureaucrats at the CDC and the FDA delayed the rapid development of Covid-19 testing by failing to adapt to emergent conditions and stuck to rigid regulations that take months and years.  These failures have been documented in publications from across the political spectrum, including conservative and libertarian outlets, and the liberal New York Times (here and here).

The FDA’s primary error was its failure to quickly approve Covid-19 tests from university and commercial laboratories.  This sort of “regulatory purgatory” has plagued the sale of vastly safer cigarette substitutes (examples here, here, here and here) -- inaction that contributes to the premature deaths of 480,000 inveterate smokers annually.  Delayed Covid-19 testing has already resulted in tens of millions of Americans having lost their livelihoods, and for far too many, their lives.

The FDA is continuing its unscientific anti-vape campaign with a Covid-19 twist.  Spokesperson Michael Felberbaum provided this warning to Bloomberg News: “People with underlying health issues, such as heart or lung problems, may have increased risk for serious complications from Covid-19.  This includes people who smoke and/or vape tobacco or nicotine-containing products.  E-cigarettes can damage lung cells.”

There is absolutely no evidence that individuals who vape have increased Covid-19 risks.  It is irresponsible for the FDA to make unscientific and unsubstantiated allegations about e-cigarettes without a shred of evidence.