The Food and Drug Administration has pushed back by six months the deadline by which clinics that offer stem cell-based treatments must start complying with FDA drug development rules, citing the coronavirus pandemic.
The agency originally said in November 2017 that companies making stem cell products for patients had three years to start following FDA rules for developing treatments, including filing paperwork for clinical trials. The move was part of an effort from the FDA to distinguish between promising stem cell therapies that were following normal regulatory steps, and untested products pushed by unregulated clinics.
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To say that the FDA’s initial 3 year period “of enforcement discretion” (now extended by 6 mos.) delays compliance obligations is inaccurate. When the FDA announced its plans to exercise enforcement discretion in Nov. 2017, it did so to encourage clinics and other developers to seek agency input to clarify, among other things, which compliance obligations would pertain to a given product (particularly with regard to the need for CLINICAL TRIALS and other aspects of sec. 351 oversight). It did not suspend these obligations and, indeed, the FDA simultaneously promised to ramp up enforcement during this period for products deemed to be particularly risky due to product type, mode of administration, marketing, etc. During this 3 yr. pd., the agency has sent Untitled and Warning letters to many clinics and in May 2018, filed suit in Florida and California against two groups of clinics for alleged violations of the same regulations (re: 351 premarket approval) that are very much in effect. The exercise of “enforcement discretion” should not be interpreted as a temporary suspension of applicable regs. or a clinic’s legal obligation to comply with them.