Test developers and the U.S. FDA are scrambling to meet the testing needs of the American public, however, it's somewhat unclear what the agency's priorities are for the emergency use authorization (EUA) program. Jeffrey Shapiro, of Hyman Phelps & McNamara, made the case that the FDA’s Center for Devices and Radiological Health (CDRH) should be more transparent about its priorities for EUA review because “even after a firm expends considerable resources, a subsequent shift in CDRH’s priorities could prevent a product from obtaining an EUA.”

Shapiro highlighted the predicament in a Feb. 25 entry at the FDA Law Blog, noting that the agency is “increasingly declining to review EUA requests and terminating pending EUAs.” He said the explanations for doing so typically revolve around either the notion that a filing represents a non-priority or that there are already adequate supplies of the article in question on the market. This latter condition is one of the necessary qualifications for issuing an EUA under Section 564(c) of the Food, Drug and Cosmetic Act.

The FDA’s director of the Office of In Vitro Diagnostics and Radiological Health, Tim Stenzel, has said on more than one occasion that the agency is swamped with EUA filings for diagnostics and related supplies and equipment. Stenzel has also noted that the agency has specific priorities, which in recent weeks includes tests that can be produced and processed in large quantities.

Shapiro said in the blog that the predicament could be ameliorated by the creation of a publicly facing database of items that are a low priority, with some sort of indicator as to which items are only a low priority as opposed to a zero priority item. Failing that, the agency could provide this type of information on its updates webpages, which would assist developers in aligning their efforts to the agency’s objectives.

Would-be test developers often caught by surprise

Shapiro told BioWorld that the reaction he gets from clients is that they are caught by surprise or were disappointed at the agency’s reaction to an EUA filing. He and his clients have had discussions with agency staff about a decision to not review an EUA application, at which point one or two clients have invoked an informal appeal. He acknowledged that the FDA still has a massive workload in front of it, but said the agency seems at times to be immovable in its decision making.

A test that is already available might not draw much of the agency’s interest even if it offers improved performance specifications, Shapiro said, but he stated, “they’ve been getting increasingly ruthless about making those calls, and they have not been amenable to changing their minds.” Agency staff have been courteous about these decisions, but the final decision is often fixed in place, at least for the time being.

Shapiro said the supply chain for testing is apparently still strained, including supplies for lab-based polymerase chain reaction testing, but the statute was intended to give the agency leeway on what is prioritized rather than to prioritize on the basis of its own resources. The point of the statute is to allow the FDA to direct traffic to the highest-value products, but the method of communicating that information is becoming more conspicuously problematic.

There are organizations that might serve as communication intermediaries to give industry a heads-up as to what is and is not a priority item, but Shapiro said it’s not clear whether any such lines of communication exist. “We talk to a lot of clients who don’t know about the de-prioritization,” he said, which prompts consultants to bring their clients up to speed on the situation. Consequently, it does not appear that the FDA is communicating with companies via trade associations.

Whether the standard problem of nation-of-origin rules is still in effect during the pandemic is difficult to say, but Shapiro said some of the firm’s clients will take up outside-U.S. markets if they find they can’t pry open the FDA’s front door. “We’ve seen quite a few clients continue with overseas opportunities when it doesn’t work out here in the U.S.,” he said.

The FDA’s Stenzel, who serves as the director of the office in charge of EUAs for diagnostics, will mention high-priority items on the weekly diagnostic testing town hall, but Stenzel rarely, if ever, mentions the types of items that are de-prioritized. Shapiro said the FDA would have a lot of flexibility in terms of notifying stakeholders about which items are low priority, such as posting a statement reflective of a de-prioritization about an entire category regardless of performance.

The agency could also indicate an interest in a particular product only so long as the candidate product meets certain performance parameters. “They could always update it if conditions changed,” he observed, but even if Stenzel offered more detail during the weekly town halls, “its not enough. We can’t all take an hour a week to listen to the town hall.”

Offering such advice during the town halls would be a good start, but Shapiro said that even if a searchable database is impracticable, providing such information via the agency’s testing FAQ page would be at least an improvement over the current situation. The agency could also provide a contact to answer more specific questions, and Shapiro said these measures might cut back on some of the current deluge of phone calls and emails.

The FDA has pipelines of information to the market that give them insight as to what is in short supply, but Shapiro said it is not clear exactly what those sources of data might be. The decision to de-prioritize something is likely a high-level conversation at CDRH, and may reflect a consensus-driven process, but Shapiro said, “they key is to know what’s going on so you don’t waste time and money.”

FDA responds

FDA spokeswoman Audra Harris told BioWorld, “we are at a different stage in the pandemic than we were a few months ago in terms of tests available and testing needs,” adding that the agency has thus prioritized review and authorization of EUA requests, “taking into account a variety of factors.”

Harris said the priorities typically revolve around “the public health need for the product and the availability of the product, with the goal of expanding overall U.S. testing capacity and patient access to tests.” Any products that increase testing accessibility, such as point-of-care tests, home collection tests, and at-home tests would qualify, as would anything that “would significantly increase testing capacity,” she said. This includes tests that reduce reliance on test supplies along with high-throughput, widely distributed tests.

“When we receive a complete submission with good data for a priority test, we move quickly to authorize it, as we have done with many tests already,” Harris said, adding that the FDA has authorized more than 300 tests and collection kits, including several tests and collection kits that allow for home collection or at-home testing. “The FDA will continue to support innovation in testing and provide flexibility to test developers with the goal of increasing the availability of accurate and reliable tests for all Americans,” she said.

Harris noted that surgical masks that include antimicrobial protection may have been cleared via the 510(k) program, which provides a more rigorous standard of review than an EUA. Any face masks and surgical masks that claim to be antimicrobial must be formally reviewed by the FDA before going to market. The agency has an EUA allocated for face masks that are intended for a medical purpose, but which are not intended to provide liquid barrier protection, and which excludes antimicrobial-containing devices. “There is a separate EUA for surgical masks which also excludes antimicrobial-containing devices,” she said.