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.