The FDA is legally established as a law enforcement agency. But its structure and activities have also generated its own “branding” as a trusted independent validator of medical devices.
This public trust gives FDA tremendous power. If a device has not undergone FDA’s premarket review (even if lawfully exempt), it often causes consternation among potential customers. Likewise, if FDA issues negative public statements about the safety of marketed devices or the compliance status of a company, there can be a significant and lasting market impact.
The use of this power is not new for FDA. Historically, FDA has made public a variety warning letters about violations available to the public (and it continues to do so). It also publicizes adverse event reports and recalls, market withdrawals and safety notices. In Class I recalls, the agency may issue its own press release. FDA issues device safety communications. FDA makes public some information on inspection results.
During the pandemic, however, CDRH has qualitatively increased its use of public lists and other information to leverage the FDA brand to protect the public health.
A few examples:
CDRH allows commercial manufacturers to distribute diagnostic test kits to perform assays to detect SARS-CoV-while the manufacturer is preparing its EUA request, provided that the manufacturer provides instructions for use of the test and posts data about the test’s performance characteristics on the manufacturer’s website. CDRH is relying upon this “[t]ransparency to mitigate potential adverse impacts from a poorly designed test by facilitating better informed decisions by potential purchasers and users.” The manufacturers and their tests are listed here, and the list expressly notes whether a test is “unauthorized” or “authorized.”
This approach has not been an unalloyed benefit to manufacturers. Some customers are unwilling to purchase products based upon notification and insist on waiting for an EUA to issue. That reflects the power of FDA’s brand. But other customers are perfectly happy to do so. For instance, some sophisticated clinical laboratories may feel that they have an adequate ability to validate the tests and do not need to rely on FDA’s validation.
As another example, CDRH maintains a list of tests that affirmatively should no longer be used or distributed here.
As a third example, CDRH issued enforcement discretion guidance allowing thermographic cameras to be commercially distributed for detecting fever during the pandemic. Upon finding that some firms are marketing the cameras in violations of the guidelines, FDA has issued warning letters. That much is not unusual (except for the demand for a response within 48 hours). But FDA also has redeployed these technical and legalistic warning letters into a plain English warning against using the products:
FDA is advising consumers not to purchase or use certain products that have not been approved, cleared, or authorized by FDA and are being misleadingly represented as safe and/or effective for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19. Your firm will be added to a published list on FDA’s website of firms and websites that have received warning letters from FDA concerning the sale or distribution of COVID-19 related products in violation of the Act. This list can be found at https://www.fda.gov/consumers/health-fraud-scams/fraudulent-coronavirus-disease-2019-covid-19-products. Once you have taken actions to address the sale of unapproved, uncleared, and unauthorized products . . . and any appropriate corrective actions have been confirmed by the FDA, the published list will be updated to indicate that your firm has taken such corrective actions.
SARS-CoV-2 Reference Panel Comparative Data | FDA (list of molecular tests and their performance against a reference panel).
EUA Authorized Serology Test Performance | FDA (list of serology tests and their expected performance).
Independent Evaluations of COVID-19 Serological Tests (Frederick National Laboratory for Cancer Research results of serology test performance – authorized and not authorized).
As a final example, in response to a great deal of (often deliberate) misinformation circulating in the public domain about the meaning of “FDA registered” and “FDA certified,” CDRH has published an explainer.
FDA took these steps in the crush of responding to the pandemic. But they point to a broader potential after the pandemic. We have gotten to the point where there has been wide and deep integration of internet-based research into business and consumer decision‑making. It is now easy to quickly find FDA’s lists and other information they may put out. For this reason, although the pandemic may have acted as a catalyst, FDA’s more aggressive use of publicity is likely to expand in the years to come.
Congress should keep an eye on how FDA evolves its use of publicity in order to ensure that this power is used responsibly. Still, Congress will no doubt appreciate that this approach permits FDA to achieve a public health impact more quickly and at lower cost than might otherwise be the case.
Finally, the song title quoted in the title of this post is from Gilbert & Sullivan’s The Mikado. The pertinent lyrics:
“I’ve got a little list.
I’ve got a little list.
Of society offenders
Who might well be underground
Who never would be missed – who never would be missed!”