Under the proposed regulation, sponsors and sponsor-investigators whose planned study falls within an exemption will not be required to submit an Investigational New Drug application ("IND") or comply with IND reporting requirements, greatly reducing regulatory and resource burdens.
In December 2022, the Food and Drug Administration ("FDA") issued a proposal to amend its IND regulations to create two types of exemptions from IND requirements for drug studies of products lawfully marketed in the United States as foods, dietary supplements, or cosmetics. While FDA regulations provide an exemption from IND requirements for certain studies of lawfully marketed drug products, stakeholders have had to rely on enforcement discretion to exempt studies on drug uses of food, supplements, and cosmetics that meet similar criteria. The FDA has received frequent inquiries from sponsors and investigators regarding whether foods or cosmetic products could be investigated with respect to disease treatment or prevention.
The "self-determined exemption" would allow sponsors to determine their study is exempt if the investigation:
- Is not intended to support a drug development plan for the product or a labeling change that would cause the lawfully marketed product to become an unlawfully marketed drug;
- Complies with institutional review and informed consent requirements;
- Does not change the route of administration of the product from that of the lawfully marketed product; and
- Meets criteria designed to protect the health, safety, and welfare of subjects.
"Self-determined" sponsors do not need to notify FDA of their determination, but FDA can take enforcement action if it finds the determination does not comport with the criteria.
The "FDA-determined exemption" would apply in one of two ways. It would allow sponsors to request an exemption from FDA when their study meets all self-determined exemption criteria outside of the health, safety, and welfare category. Under the exemption, sponsors would include in their FDA submission a description of why the study does not present a potential significant risk to subjects. Alternatively, under this exemption, FDA would have the ability to grant an exemption on its own initiative when it determines a study applying for an IND qualifies.
Comments may be submitted through March 9, 2023.
