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Five Things That Changed Forever at FDA in 2022
(Thursday, January 5, 2023) The year 2022 was the year when the pandemic came to an end, unofficially at least, but there are many things at FDA that started with the pandemic and changed it for good. While these changes may not affect the core rules, they affect the relationship between the FDA and all the stakeholders in significant ways. First, industry meetings with FDA are changed for good. FDA announced earlier last year that it will no longer accept in-person meeting requests. All FDA-industry meetings, with rare exceptions, would be held virtually. The days of companies lining up at FDA’s campus near Washington DC to sit across the table from FDA reviewers and chat in a controlled setting are over. FDA would conduct primarily audio only meetings. Although FDA prefers Zoom for its virtual meetings, FDA personnel rarely appear on video. While one can argue the benefits of virtual meetings, these in no way come close to the perception of transparency and personal touch offered by sitting across the table. The virtual meeting format will inevitably increase the perception of aloofness and non-relatedness between FDA reviewers and the stakeholders. Second, last year FDA slowly withdrew most of pandemic related regulatory flexibilities that started in 2020. In the new year, FDA expects formal approval for all products marketed under EUAs and would treat Covid-related treatments and preventive measures as conventional non-priority products. Third, autologous stem cell treatment clinics got a huge anti-FDA Federal court decision earlier in the year and FDA’s silence on the matter is deafening. It seems FDA has decided to tacitly allow stem cell clinics that offer stem cell therapies of all kinds directly to patients. FDA would use its enforcement discretion policies to go after only the most egregious of cases where adverse events occur related to these treatments but allow almost all other clinics. This perception has led to a sudden boost to stem cell clinics which for the last 4-5 years were living in fear of prosecution by the FDA. This perceived policy goes against FDA’s longstanding desire to regulate stem cell clinics. We will see if it changes this year, but chances seem slim unless there is a major event that pushes FDA to act differently. Fourth, FDA’s audits would also be mostly virtual. FDA has been teasing the industry with proposals for reduced on-site inspection as a reward for past good record. The pandemic gave FDA a good excuse to test its virtual inspection and alternate review programs. It seems FDA is now emboldened to continue virtual audit-rich enforcement practices, despite increased criticism by the watchdogs. Fifth, several controversial rules are here to stay on in 2023. The accelerated approval program withstood several challenges. The regulation of LDTs suffered a major set-back in the Congress despite strong lobbying by interest groups. Many digital health products were approved despite limited acceptance by doctors, patients, and payors. The US supply drug chain continues to rely heavily on foreign manufacturers with more than 90% of new generic drug approvals going to manufacturers based outside the US. And patient lobbying influenced FDA’s decision more than the clinical trial data as shown by several controversial approvals. The year 2023 will continue these trends. 
AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: [email protected] Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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