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Are FDA’s In-Person Meetings Coming Back in the Fall?
(Thursday, April 8, 2021) One of the casualties of the pandemic last year was the in-person meetings with FDA reviewers. For obvious reasons, FDA converted all its meetings since March 2020 to the virtual or phone call format as an alternate to in-person meetings on the FDA campus. Now, as the pandemic slowly winds down in the US, would we go back to in-person meetings or are virtual meetings here for good? We should get some clarity by the Fall. FDA has not given any indications in either direction, so speculations abound. Meetings with the FDA reviewers are considered a critical tool for developers to discuss all kinds of issues regarding their development programs with the reviewers. Meetings have been demonstrated to build rapport and increase the odds of favorable outcome for the developers. Over the last 3 decades FDA has strongly advocated to sponsor to meet with it to discuss any issues and developers have come to heavily depend on meetings with FDA for critical troubleshooting. An in-person discussion provides an invaluable perspective to the two parties that cannot be replicated via phone calls. Body language, eye contact, group dynamics, and tone are mostly lost in phone conference calls. Also, telephone meetings had been prone to technical issues last year since almost everyone was calling from their homes with intermittent connection issues. FDA has resisted requests for video or Zoom calls and only grants phone meetings, making it hard for either party to properly communicate. While the FDA teams worked hard to make these meetings conducive to both parties, it cannot be denied that many developers would have probably benefited more from in-person meetings. Last year there wasn’t any grumbling from the industry about virtual meetings because that was the only option available, the policy was presumably temporary during to the pandemic, there was reduced clinical trial activity (clinical trial related meetings are the most common meetings with FDA), and there were reduced number of meetings overall since FDA denied most meetings in lieu of written-responses-only citing Covid related regulatory burdens. But with the pandemic related restrictions easing over the next few months, one should expect that in-person meetings would come back. FDA has been quiet about this. All public meetings announced so far, till June, are virtual meetings. But there is a silver lining. By June, all adults in the US would have access to Covid vaccines and most public places may start going back to normal in-person conduct, with conditions of course. For the government, a big display of normalization would be to revert to some pre-pandemic practices; in-person meetings are an easy and a great visual indicator of times changing back to normal. There may be restrictions such as on-site screening, requiring negative Covid tests, vaccination passport, and masks, just like there are for other “normal” activities. The big question is the importance FDA places on “meetings” with sponsors for its mission, because a phone call or a written response is far from a “meeting”. FDA could start granting video meetings instead but return of the in-person meetings will be critical component of FDA’s normalization. Worst case scenario: FDA decides that the new “normal” is virtual meetings only. We will find out by this Fall, one way or another. 
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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