The Penalties of the Pandemic: Pain Points That Intend to Stay
(Thursday, December 17, 2020]​
It seems like stating the obvious, but the pandemic will have some long-term negative effects on the FDA-regulated industry at least for the next few years which would tangibly and perceptively affect new product development and healthcare. Here we list five that seem most obvious to us. First, there is a huge backlog of clinical trials. Trials that were stopped last year would need to restart and new trials that were not launched would compete with them for the same resources. This would create a surge of demand for everything related to clinical trials and not enough to fill that demand. There were more than 20,000 new clinical trials initiated annually till last year. This year saw a drastic drop in the number of new trials launched. And it would take us a few years to catch up. Second, due to the stoppage of clinical trials, many trained clinical research staff were furloughed or laid off. Many of those people may have moved on. Just like the resource backlog, we are bound to see staffing shortages as well, at least in the next 1-4 years. This may be addressed to some extent with virtual trials and automation but that won’t be enough. Third, there are new misplaced expectations from the FDA regarding new product review and approval. Both the vaccines for Covid were developed practically from scratch to approval in less than 11 months. This is a fastest and likely the only example of its kind in FDA’s history. Future developers could and should expect similar faster decisions by the FDA which are unlikely. The pandemic presented an unprecedented circumstance which pushed the FDA, with the help of other government agencies, to move at an abnormal pace. FDA specials teams were created and all non-Covid related work was moved back to make space for the Covid products. This is a one-off event. FDA cannot continue like this for long. It would need to move back to its normal pace soon. This may create a bad vibe for FDA with the sponsors who expect unrealistic turnaround times. Fourth, the pandemic exposed that FDA, NIH, and CDC are extremely vulnerable to political pressures. All three government agencies were made into tools of the political football. Even seemingly simpler and straight-forward decisions were made to look like politically motivated leading to public mistrust. This exacerbated to urgency to create truly politically independent healthcare agencies which is hard to imagine in the near future. This damage to their reputation will take years to rebuild. Fifth, the pandemic highlighted the total dependence of the US supply chain on foreign suppliers. The country was entirely dependent on manufacturers in China for even simple things like face masks and gloves. Malicious players in China took advantage of that and supplied sub-standard products making FDA play whack-a-mole with suspending suppliers with bad tests, bad masks, and even fake US agents. The dependence of the US consumers on non-US, seemingly uncontrolled suppliers, is an ongoing problem that was just highlighted by the pandemic and there is little that can be done about that in the near future. There are potentially other negative consequences of the pandemic but the above present the most obvious ones. The pandemic created opportunities for improvement by highlighting the deficiencies. We are sure that the lessons from the year 2020 with regards to healthcare and pharma products will become a part of our training for all times.