10 November 2020
The FDA had already announced its strategy for regenerative medicine, including cell therapies, in November 2017. This included a 36-month period during which those developing such products should evaluate whether their products require pre-market approval. The FDA also announced that it would make use of its discretionary powers with respect to Premarket Approval during this period, if use of the product in question does not raise any reported safety concerns or potentially significant safety concerns.
In a paper published by the FDA on 12 June, "Temporary streamlined program to help manufacturers of human cell, tissue, and cellular and tissue-based products – including stem cell treatments – understand the appropriate regulatory pathways
for their products" , the responsible Acting FDA Commissioner Ned Sharpless notes that half of the timeframe has already passed and that the feedback from developers and manufacturers of human cells, tissues, cellular and tissue-based products was significantly lower than expected. He explains that a temporary programme will therefore be set up to help manufacturers and those who market products to physicians or patients to quickly receive an informal, non-binding FDA assessment of how their products are regulated.
At the same time, he notes that the FDA will continue to respond to the fact that there are many cases where companies make unconfirmed claims about the potential of human cells, tissues and cellular and tissue-based products to prevent, treat or cure serious diseases (see News "FDA keeps an eye on use and marketing of cell and tissue products") .In such cases, the FDA will take action to protect patients. (see News "FDA issues Warning Letter to Manufacturer of Human Cells, Tissue or Cell based Products").
In order to further support the affected manufacturers in the second half of the 36-month period and to submit corresponding inquiries to the FDA, the FDA has launched a temporary programme until 31 December 2019, the Tissue Reference Group (TRG) Rapid Inquiry Program (TRIP), to obtain the above non-binding assessments. The Agency intends to respond to requests containing sufficient details for the evaluation within three days of receipt, if resources permit.