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                Cellular & Gene Therapy Products

Cellular & Gene Therapy Products

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          Cellular & Gene Therapy Products
          Questions and Answers Regarding the End of the Compliance and Enforcement Policy for Certain Human Cells, Tissues, or Cellular or Tissue-based Products (HCT/Ps)Cellular & Gene Therapy Products Questions and Answers Regarding the End of the Compliance and Enforcement Policy for Certain Human Cells, Tissues, or Cellular or Tissue-based Products (HCT/Ps)
  
  	
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    Print**Q: Why did FDA announce a compliance and enforcement policy for certain HCT/Ps?**
A: As stated in the guidance, *Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use*, issued in November 2017 and updated in July 2020, FDA announced this policy to give manufacturers time to determine if they need to submit an IND or marketing application in light of this guidance and, if such an application is needed, to prepare the IND or marketing application.

**Q: After May 31, 2021, what is FDA’s compliance and enforcement policy for HCT/Ps?**
A: After May 31, 2021, FDA no longer intends to exercise enforcement discretion with respect to the IND and the premarket approval requirements as described in its Compliance and Enforcement Policy Regarding Certain Regulatory Requirements.

**Q: When the compliance and enforcement policy expires, what will be FDA’s approach to compliance and enforcement for HCT/Ps that were subject to this policy?**
A: As a general policy, FDA does not comment on its compliance or enforcement approach and therefore cannot comment further.

**Q: For an HCT/P that is not regulated solely under section 361 of the Public Health Service Act (PHS Act) and the regulations in Part 1271, and instead is regulated as a drug or biological product under section 351 of the PHS Act and the Federal, Food, Drug, and Cosmetic Act, what must a manufacturer  do?**
A: FDA expects all establishments that manufacture HCT/Ps regulated as drugs or biological products to have an approved biologics license application (BLA) or an investigational new drug application (IND) in effect. An approved BLA is required to lawfully market these products. While in the development stage, such products may be distributed for clinical use in humans only if the sponsor has an investigational new drug application (IND) in effect.

**Q: I currently market/offer for sale an HCT/P that requires FDA premarket approval but does not have it. May I continue to offer this product for sale after May 31, 2021?**
A: A product that requires but lacks premarket approval may not be lawfully marketed, including when a sponsor has an IND or is pursuing an IND or BLA. After May 31, 2021, FDA no longer intends to exercise enforcement discretion with respect to the IND and the premarket approval requirements, as described in its Compliance and Enforcement Policy Regarding Certain Regulatory Requirements.

**Q: What could happen if after May 31, 2021 I continue to market/offer for sale an HCT/P that requires but lacks premarket approval as a drug or biological product?**
A: FDA no longer intends to exercise enforcement discretion with respect to the IND and the premarket approval requirements for certain HCT/Ps, as described in its Compliance and Enforcement Policy Regarding Certain Regulatory Requirements. If you market/offer for sale an HCT/P that requires premarket review as a drug and biological product, you do so at your own risk.

**Q: If I submit an IND for my HCT/P, may I continue to market the product/offer it for sale?**
A: A product that requires but lacks premarket approval may not be lawfully marketed/offered for sale, including when a sponsor has an IND or is pursuing an IND or BLA.

**Q: I administered an HCT/P that requires but lacks premarket approval to a patient with a good response prior to May 31, 2021. Can I continue to administer this product to this same patient(s)?**
A: No, a product that requires but lacks premarket approval may not be lawfully marketed. You may not administer an unapproved product without an approval or IND that is in effect.

**Q: If I have an IND in effect, can I administer the same product to patients as treatment outside of the IND?**
A: No, even if you have an IND in effect, the unapproved product may not be administered as a treatment outside of the IND.

**Q: I have been administering a HCT/P that requires but lacks premarket approval to patients, and the manufacturer has informed me that there is an IND in effect for the product. Can I contact FDA to confirm that this is true – that the product has an IND in effect?**
A: Under FDA’s regulations, the agency cannot disclose the existence of an IND. You can confirm whether a product has an IND in effect by obtaining from the sponsor the FDA-issued IND number as well as a copy of the official FDA communication acknowledging the IND.

Please keep in mind, however, that an IND is not marketing authorization for a product. Rather, when an IND goes into effect, a product sponsor can ship an investigational new drug and unlicensed biological product to clinical investigators without an approved marketing application (e.g., BLA). If you are receiving a product that has an IND in effect, then you would be considered a clinical investigator associated with the IND.

**Q: What must I do if I purchased an HCT/P prior to the end of enforcement discretion and want to administer it to a patient after the end of enforcement discretion?**
A: An HCT/P that requires but lacks premarket approval should be administered only if there is an IND in effect for that product, for that sponsor, and applicable for that use.

**Q: Can I recoup the cost of producing my HCT/P while it is being studied under IND?**
A: FDA has issued regulations on charging for investigational drugs under an IND for the purpose of either research clinical trials or expanded access for treatment use. These regulations can be found in 21 CFR 312.8, and additional information is provided in FDA guidance. In summary, IND sponsors may recoup certain costs for a specified product; however, FDA must authorize such requests to charge.

**Q: If I submit an IND for my HCT/P, may I charge patients for the product?**
A: FDA has regulations on charging for investigational drugs under an IND for the purpose of either research clinical trials or expanded access for treatment use. These regulations can be found in 21 CFR 312.8, and additional information is provided in FDA guidance. In summary, IND sponsors may recoup certain costs for a specified product; however, FDA must authorize such requests to charge.

**Q: I see that the FDA’s Tissue Reference Group Rapid Inquiry Program (TRIP) concluded March 31, 2021. Where can I direct questions as to how my HCT/P is appropriately regulated after this time?**
A: Although the temporary TRIP program has concluded, there are many mechanisms available to determine how an HCT/P may be appropriately regulated:

First, you may wish to consult the FDA guidance, *Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-based Products, Minimal Manipulation and Homologous Use*.

If after reviewing this guidance you still have questions, you may file a request for a recommendation with the Tissue Reference Group (TRG) or submit a Request for Designation (RFD) with the Office of Combination Products (OCP). Additionally, you are welcome to submit a pre-Request for Designation (pre-RFD) for a preliminary assessment of your product from OCP.

**Q: Did the compliance and enforcement policy apply to platelet rich plasma (PRP)?**
A: As stated in our guidance for industry, “Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use”, updated July 2020, PRP is blood taken from an individual and given back to the same individual as platelet rich plasma. PRP is not an HCT/P because it is a blood product. Therefore, the compliance and enforcement policy did not apply to PRP or other blood products.

                                                                                  Content current as of:
      07/09/2021
              
              
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