The New Regulatory Normal

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The emergency orientation of FDA and other agencies will be reorienting medtech companies' regulatory efforts for the foreseeable future.

This column  will appear in the April 2020 print issue of Market Pathways. Sign up for a free trial here

“I do not personally foresee this emergency declaration going away anytime soon. We are talking at least years,” said FDA’s diagnostics chief Tim Stenzel in an offhand comment about 40 minutes into one of his weekly “Town Hall” Q&A sessions.

The comment anchors what should be growing realizations for all of us: that normalcy is not returning any time soon, and that any steps the general population is able to safely take toward getting back into public and to work will depend on the US and other countries remaining on an emergency footing for a long time. That means a public health and fiscal policy infrastructure that continues on high alert to constrain viral spread (in particular, until a vaccine is available) and help prevent the most dire economic outcomes.

FDA (as well as CMS, and other health agencies in the US and abroad), derives regulatory flexibility from the now two-and-a-half-month-old HHS-declared public health emergency to which Stenzel referred. At base, the declaration allows FDA to leverage its Emergency Use Authorization authority, but in the context of the COVID-19 pandemic, it has prompted a broader range of accommodating regulatory policies. It is rare for a day (including weekends) to go by where FDA does not release at least one new coronavirus policy that, in the agency’s words, “is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Department of Health and Human Services.”

Put in the context of Stenzel’s recent comments, that doesn’t sound very restrictive. We are in a new regulatory normal for the foreseeable future, and medtech developers must be mindful of that.

On the one hand, the amount of leeway FDA is willing to give right now for medtech solutions is unprecedented, and companies should be ready to deal more creatively with the agency than previously thought possible. Within Stenzel’s product jurisdiction, FDA is allowing diagnostics firms to roll out assays before FDA has reviewed them. And the agency is applying an extraordinarily light regulatory touch as companies and clinicians think outside of the box to modify anything with the potential to support breathing or act as protective equipment. But the flexibility extends beyond specific interventions for COVID-19. Included among policies with the “only for the duration of the public health emergency” statement are shortcuts and carve-outs for:

This list is expected to grow as new needs are identified for society to operate a healthcare system amid an ongoing epidemic threat. For instance, as efforts begin to restart elective procedures and other important health services that have been postponed by the pandemic, what medical technology innovations can be put into play to help that happen more safely? Companies should be ready to offer solutions to regulators who will more quickly be willing to accepting them than in the past.

On the other hand, this environment of emergency regulating comes with serious challenges. For one, medtech developers must be mindful of their greater responsibility for patient safety as they push ahead with solutions with fewer or different regulatory checks in place. One just has to look at the current situation with serology antibody tests for COVID-19, where FDA has opened up a path for labs and firms to offer assays without an authorization, and reports of mislabeled and inaccurate tests hampering efforts to increase regional virus tracking are flowing in.

In addition, all of these emergency efforts have the potential to take resources and attention away from many important medtech innovation efforts for healthcare issues not tied to COVID-19 or remote healthcare. FDA has recently affirmed that it is continuing work on routine submission reviews under its user fee programs, but as staff addresses COVID-19 priorities, “it is possible we will not be able to maintain our current level of performance indefinitely,” FDA Commissioner Stephen Hahn said April 16 with regards to the device review program. This is a burden device companies will need to confront in the years ahead.

More broadly, companies and FDA alike should be thinking critically about how the current experience might inform regulating devices and diagnostics, such as where government attention is most effectively placed and where enforcement leeway is most warranted and appropriate. FDA had been set in early April to convene a kick-off meeting for a multi-year process to reauthorize the medical device user fee program, which serves as the statutory framework for how device reviews are conducted. The meeting has now been postponed until further notice. That’s probably for the best. As Stenzel suggests, we are still very much in the middle of this ongoing emergency, and we all need more time to reconsider the policy implications.

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