FDA to End Enforcement Discretion for Cell and Tissue Products

April 27, 2021

The Food and Drug Administration will end its compliance and enforcement discretion policy for certain human cell, tissue, and cellular and tissue-based products (HCT/Ps), including regenerative medicine therapies, on May 31, Peter Marks, MD, PhD, director of the Center for Biologics Evaluation and Research (CBER) announced recently in FDA Voices.

FDA outlined this enforcement discretion period as part of the November 2017 regenerative medicine policy framework, which the agency introduced to spur innovation in regenerative medicine therapies through expedited programs that support product development and licensure.

The policy gave manufacturers time to determine if certain requirements, such as the need for an investigational new drug (IND) application or pre-market approval, applied to their products. It also provided time for manufacturers to prepare and submit the appropriate application. 

Despite these efforts, Marks noted that there continues to be broad marketing of unapproved products for the treatment or cure of a wide range of diseases and medical conditions. Many of these unapproved products appear to be HCT/Ps that are regulated as drugs, devices and/or biological products subject to premarket approval requirements. 

Marks reiterated that the agency will continue to act regarding unlawfully marketed products, including issuing warning and untitled letters, and pursuing enforcement action for serious violations of the law. FDA has issued more than 350 letters to manufacturers, clinics, and health care providers since December 2019, noting that it has come to the agency’s attention that they may be offering unapproved regenerative medicine products.

Furthermore, Marks encouraged patients who are considering treatment with regenerative medicine products to work with their health care providers to learn about the treatment being offered. The public can find out if a particular regenerative medicine product is approved on FDA’s website.

Linda Barnes, DrPHc, MHA, RAC (RAPS), AABB’s vice president, Biotherapies, expressed the Association’s support for FDA programs facilitating innovation in product development and encourages voluntary compliance with FDA regulations. 

“FDA’s programs to foster product development and licensure were a tremendous resource for manufacturers looking to develop transformative regenerative therapies for new indications,” Barnes said. “AABB is grateful for these programs and supports FDA’s ongoing work to streamline the regenerative medicine approval process to protect public safety and trust.”