How Easy is it to Get an IND from FDA for a COVID-19 Drugs?
 [Thursday, April 16, 2020]

Typically, an IND application requires months and years of research and development, and a reasonable rationale for the potential treatment. Since the announcement of the pandemic about 2-3 months ago, there have been hundreds of clinical trials initiated for products intended to treat or prevent the disease. This may seem like an awfully short time for so many potential treatments to be developed sufficiently for testing in clinical trials. Even more it may seem like many of these INDs were cleared by the FDA quickly and probably with reduced review. There are some factors that may contribute to the seemingly faster than normal IND clearance rate. Many of the INDs are for repurposing previously approved drugs for COVID-19 or drugs already in clinical trials for other indications. Such trials are easier to clear for FDA since they likely have a reasonable safety profile. However, the first-in-man clinical trials are harder to justify. For example, FDA cleared two clinical trials for using stem cells to increase immunity against the coronavirus when there is scant evidence that stem cells can do so. FDA has promised to ultra-expedite approval of new therapies for COVID-19 promising unheard of timeline such as responses with 24 hours and clearance with 3 days. With those kinds of timelines one can speculate that FDA is looking only for major red-flags and not in-depth review of these INDs allowing practically all INDs through. IND is just the first step in the development of a new product; it does not endorse the potential of a given product by FDA, but just that the FDA agreed that product is safe enough to test in humans. So, the threshold for getting an IND cleared by FDA is quite low in general, and not just for COVID-19 products. While these are times of an extreme emergency, and more trials could theoretically mean better chance of finding a treatment quickly. On the other hand, it could also clog the extremely limited clinical trial resources to conduct these trials and theoretically hinder development of a treatment. Many of these trials are with new products and various product rationale for treating the virus, but there are also a few that seem simply attempts to monetize the panic and urgency created by the pandemic. In times of emergency it won’t be unreasonable to expect that the regulators be the voice of reason and try to provide not only a fair and balanced review but also a critical review to assure the patients that the drugs being tested are valid options and not frivolous attempts at attention. It is indeed very easy to get an IND cleared by FDA for a COVID-19 product. And we will keep seeing hyped up news releases touting an IND clearance as it is an FDA clearance to treat till the pandemic is over.