FDA’s Tango with the EUAs Exposed an Agency Disconnected from the Real World
(Thursday, March 25, 2021)
Did the notification process, used as a precursor to filing an EUA for Covid diagnostic tests, help or hurt both the consumers and developers? A review of last years’ experience with the notification process for the EUA showed that FDA’s plan was poorly thought, knee-jerk reaction in the early days of the pandemic, and ended up creating confusion and agony for everyone involved, except, perhaps the FDA. In March last year, a few days after the announcement of the pandemic, FDA announced that any developer with a Covid diagnostic could start selling its tests in the US with just a notification to the Agency of its intent to file an EUA. Within weeks, hundreds of such notifications were filed. The FDA was caught off-guard by the onslaught of these applications creating a logjam where applicants did not hear back from the FDA for weeks and months after filing such notifications. Any contacts with the Agency to get a status update were rebuffed, while FDA kept releasing multiple versions of its “EUA templates” that were updated frequently with increasingly strict criteria. An egregious failure was when FDA announced a collaboration with NIH to evaluate the diagnostic tests submitted voluntarily to it by developers with a promise for a quick decision based on internal tests. But that program was fraught with excessive delays with no updates or feedback to participants for extended periods of time. The program was abandoned after a few months. Meanwhile, the EUA applications piled on at FDA with no responses to developers. The confusion about the notification process and the associated EUA led to so much confusion that most manufacturers with notification only could not market their products creating stockpiles of unused tests while the consumers and public health agencies had to deal with test shortages. In many cases, it took FDA months to assign reviewers to the EUAs. To add salt to the wounds, when such reviews were completed months later by the FDA reviewers, most developers were given less than 48 hours to respond to extensive comments, an unrealistic timeline, literally assuring that almost no one could respond in time, leading to rejection by the FDA. An excellent blog this week describes how common this ordeal was for companies pursing the EUA pathway for their tests for Covid-19 last year. The EUA process was projected to help get tests available faster and present a friendly and supportive FDA. But it ended up being an uncertain, unpredictable, and arbitrary process which created more pain for many companies and did not help consumers. Rules were amended announced and implemented with little notice and seemed arbitrary. Even for something as simple as a diagnostic test, FDA seemed to be lost. Most critically, it showed an Agency which was oblivious to the real world realities for the companies it is mandated to regulate. It is imperative that the process followed by FDA for its EUAs be investigated independently so we can learn from this and be ready for future.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC