FDA ad police's warning letters have stalled during COVID-19, and that's likely the new norm: expert

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The FDA promotional watching unit, OPDP, has yet to send a warning letter during COVID-19, continuing a slow decline in that kind of enforcement. (FDA)

Enforcement letter output from the FDA’s advertising watchdog has slowed to zero during the COVID-19 pandemic. Only one letter from Office of Prescription Drug Promotion (OPDP) has been sent in 2020, and that was back in February, before the pandemic shutdowns began.

While COVID-19 is partly to blame, OPDP letter activity likely won’t pick up much even after the pandemic clears, says a veteran FDA watcher.

While the FDA, OPDP's parent, certainly has bigger issues to deal with during the current coronavirus crisis, the slowdown of warning and untitled letters has been a larger and ongoing trend in general, said Eye on FDA blogger and public relations professional Mark Senak. Looking back over the past five years, for instance, annual letter output ranged from five to 11.

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It’s a far cry from the hundreds sent in the ‘90s and says much more about FDA priorities than any direct COVID-19 effect, Senak said.

“A few years ago, (former FDA commissioner) Janet Woodcock had an interview where she said basically ‘Well, you know FDA has to put its resources where the risk is,’” he said. “And the risk is pretty minimal in promotional communications. You aren’t going to see a Tweet about a prescription product and let’s say it only has a link to the risk information. You aren’t then going to run to your doctor and ask for a prescription and never have any more information than what was in that tweet. Your doctor is not going to just give you the drug and if you do get it, you will also get the risk information from him or the box insert, for example.”

“It’s not like anybody dies from a bad promotion,” he added.

But what does mean for pharma? For Big Pharma, it will be mostly business as usual. As Senak noted, the Big Pharma companies he works with have streamlined systems for promotions in place that check regulatory boxes and processes to make sure advertising is compliant.

Smaller companies that are new to drug promotion may still need to learn the regulatory ropes, and that is probably where OPDP will focus it efforts, as it has done in recent years.

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That said, Senak still thinks there is a gap in promotional digital guidelines that the FDA and OPDP should be working to clarify. The agency has been promising digital guidelines since 2010, but it only issued a few limited documents in 2014. Almost every year, the annual guidance agenda leaves digital items unresolved, he said.

Now during the COVID-19 pandemic, with more people turning to telehealth and even more often seeking health information on the web, may be the time to address areas in need of attention, such as mobile websites and appropriate use of links.

“The pandemic certainly presents one not only with the opportunity to provide clarity on these and other aspects, but the overwhelming need for such attention. It is difficult to say what enforcement will look like for the balance of the year, but it certainly seems like a good time to focus on some gaps,” he wrote in a recent blog post.

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