Emergency Situation is Not A “Free-For-All” for FDA-Regulated Products
[Thursday, April 2, 2020]
The coronavirus pandemic has FDA on its toes, not just to get as many products to diagnose, treat or prevent COVID-19 to the patients, but also to rein in opportunists and scam artists who want to monetize on the crisis by selling fake and unreliable products. An emergency does not mean that the regulators are not paying attention to their main job, i.e., regulating the products. Last few weeks have seen the FDA slowly defer or relax rules for use of products such as allowing serological diagnostic tests to be sold with just a notification to the FDA, allowing import of masks and ventilators without formal approval, accepting numerous emergency use INDs, and approving emergency use authorization based on imperfect evidence. This may have given the impression that FDA would let anything slide due to the emergency. On the contrary, FDA has also been withholding products with incomplete documentations at the ports of entry, questioning clinical trial applications for products with questionable rationale, and issuing warning letters to companies selling unapproved products for the treatment and prevention of COVID-19. An emergency is a time when the regulators need to be extra vigilant to protect consumers from scams. A crisis gives rise to numerous dubious “experts” who use the opportunity to sow misinformation, and in the age of internet, the misinformation can easily become an “alternate fact” allowing ill-intentioned players to take advantage of the scared populace. If there is a valid product, the best way to move it forward for the treatment of the pandemic is to bring it the patients via FDA-regulated and FDA-approved pathways. There are dedicated teams of FDA reviewers and senior management created specifically to expedite the review of any product idea pitched for use in the treatment or prevention of COVID-19. A combination of well-established processes such an emergency use authorizations and emergency/compassionate use INDs along with newer processes such as the policy to allow antibody-based diagnostics with notification only, and new processes such as the Coronavirus Treatment Acceleration Program (CTAP), offers many ways for credible ideas to find a way to patients. And if someone is still trying to work around these relatively easy pathways, their intent to mislead and scam consumers should be automatically obvious.