As the end of the COVID pandemic appears into view, the Center for Devices and Radiological Health (CDRH) appears to be taking steps toward shedding at least part of its Emergency Use Authorization (EUA) caseload.
Under Section 564(a)(1) of the Federal Food, Drug, and Cosmetic Act, FDA has discretion whether to issuance an EUA. Under Section 564(c), FDA may only issue an EUA if the following criteria are met:
- The product may be effective in diagnosing, treating, or preventing the disease or condition.
- The known and potential benefits outweigh the known and potential risks.
- There is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating such disease or condition.
CDRH is increasingly declining to review EUA requests and terminating pending EUAs. Two rationales are typically offered. One rationale is that, given the volume of EUAs, a particular EUA is simply not a priority. CDRH usually provides little or no additional information about why a product is not a priority.
A second rationale is that that there are already adequate supplies available in the market. Based on this finding, the requirement in the last bullet, above, is not met and an EUA cannot issue.
Even if CDRH has issued prior EUAs in a product category, supply conditions may change. Indeed, the issuance of prior EUAs may have helped better supply the market. CDRH’s position is that it cannot continue issuing EUAs if there are adequate alternatives in the market.
CDRH has adopted deprioritization across a range of product categories. Diagnostics have been particularly hard hit, but they are not alone.
Here are three examples:
- In the past few months, CDRH deprioritized antibody serology tests for COVID. It then proceeded to terminate pending EUAs and declined to accept new ones.
- A PCR test for COVID may still receive an EUA if indicated for, e.g., point of care, but CDRH has deprioritized some tests on the ground that they were indicated only for laboratory use.
- The umbrella EUA for face masks does not extend to masks made with antimicrobials. In theory, it should be possible to obtain an individual EUA for an antimicrobial face mask. The reality is that CDRH is unwilling to expend resources reviewing such an EUA; they are deprioritized.
There is little or nothing that can be done to challenge FDA’s prioritization decisions. Section 564 gives the agency very broad discretion. Therefore, if firms are considering pursuit of an EUA, they should be wary. To avoid wasting money, firms need to assess the deprioritization risk carefully.
Of course, it is not that easy to assess this risk, especially when FDA institutes deprioritization based on changing market conditions. Also, not all product categories are treated the same way. In some, CDRH may suddenly simply stop accepting new EUAs. In other categories, CDRH may be skeptical but still be willing to authorize a product. For instance, in some cases, they may be willing to review an EUA if (and only if) a manufacturer has the capability to produce in high volume or for a non-laboratory setting.
CDRH could help everyone better assess deprioritization risk by creating a public database of deprioritized product categories, with designations as to whether they are entirely or only partially subject to deprioritization. If not a database, CDRH could perhaps at least provide prioritization updates on their EUA FAQ web page. This increased transparency would help firms better align themselves to CDRH’s priorities.
Bottom line: In every new EUA project, firms should factor in deprioritization as one of the risks to be concerned about. Even after a firm expends considerable resources, a subsequent shift in CDRH’s priorities could prevent a product from obtaining an EUA.
In the world of EUAs, caveat emptor rules the day.