FDA Extends Enforcement Discretion until May 2021

The U.S. Food and Drug Administration (FDA) extended the enforcement discretion policy for tissue allograft 361 regulated products from November 2020 to May 2021. 
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FDA Announcement
https://www.fda.gov/news-events/press-announcements/fda-extends-enforcement-discretion-policy-certain-regenerative-medicine-products
 
This added runway provides four additional months for companies selling 361 products to become compliant.  For the past three years, FDA has consistently asked companies to file INDs for their tissue allograft products and have created a number of pathways for companies to meet with the FDA and advance their products to the clinic.  One of the more effective portals for understanding how the FDA intends to regulate your company’s products is an Interact meeting. 
 
From the FDA website:  “INitial Targeted Engagement for Regulatory Advice on CBER producTs (INTERACT) meeting is an informal non-binding consultation with the Center for Biologics Evaluation and Research (CBER) at FDA. An INTERACT meeting enables sponsors to obtain preliminary informal consultation for innovative investigational products at an early stage of development on issues that are not yet at the pre-IND meeting phase.”
https://www.fda.gov/vaccines-blood-biologics/industry-biologics/interact-meetings
 
These links provide some solid advice on what to expect in an Interact meeting and how best to prepare.
https://www.parexel.com/news-events-resources/blog/former-fda-expert-provides-valuable-advice-interact-programs-cber-products

This link has the FDA SOP for the Interact meetings.
https://www.fda.gov/media/124044/download
 
No one has a crystal ball and can accurately predict what actions, if any, FDA plans to take come May 2021 but as the President of the Perinatal Stem Cell Society, I have been fortunate to have several conversations and meetings with the current FDA leadership and I fully believe that they understand the clinical potential of perinatal tissue and stem cell products. 
 
I strongly urge any and all companies in the biologics field to meet with the FDA and to work to become compliant.  The last thing I want to see develop in the field is that high quality manufacturers are restricted from providing patient populations in need safe perinatal tissue and stem cell products and as a result these patients are forced to try tissue products from unsafe venders and fringe operators.  
 
FDA Announcement
https://www.fda.gov/news-events/press-announcements/fda-extends-enforcement-discretion-policy-certain-regenerative-medicine-products
 
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters

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