LabelingCOVID-19 convalescent plasma must be properly labeled. FDA provided several requirement and recommendations:The container label of COVID-19 convalescent plasma units must include the following statement, “Caution: New Drug--Limited by Federal (or United States) law to investigational use” (21 CFR 312.6(a)). In addition, the requirements in21 CFR 606.121for the container label apply, including the requirement to refer to the “circular of information” on such plasma.

IND, that a product is on clinical hold, that a particular study is intended to serve as the primary basis of a claim of effectiveness for approval, and the submission/filing status of its NDA or BLA.For sponsors that would like to provide access to patients, but do not want to disclose such information, they can instead pursue traditional Expanded Access (note, a section of the law entitled “Sense of the Senate” explains that “Right to Try” is intended to act as “an alternative pathway alongside” the existing Expanded Access program).The Extent of Regulatory Exemptions under ‘Right to Try’While ‘Right to Try’ use of investigational drugs are exempt from many of FDA’s IND requirements (sections 502(f), 503(b)(4), 505(a), and 505(i) of the Federal Food, Drug, and Cosmetic Act, section 351(a) of the Public Health Service Act, and parts 50, 56, and 312 of title 21, Code of Federal Regulations), it is still subject to the regulations requiring certain labeling of an investigational drug (21 C.F.R. 312.6), prohibitions against preapproval promotion of the drug (21 C.F.R. § 312.7), and limitations on costs that can be charged for an investigational drug (21 C.F.R. § 312.8(d)(1)).There is also a separate new requirement for sponsors who allow “Right to Try” use to submit an annual report to FDA that includes:Number of doses supplied;Number of patients treated and for what uses; andAny known serious adverse events.Ultimately, and similar to Expanded Access, there is no requirement for a sponsor to provide access to an investigational drug. In fact, the law exempts sponsors from any litigation related to not supplying an investigational drug under ‘Right to Try,’ and shields the sponsor and physician from most litigation in cases that the sponsor does supply of the investigational drug.Protections Against Using ‘Right to Try’ Outcomes in FDA Decision-Making?While generally, the new law proscribes that clinical outcomes associated with the “Right to Try” use of an investigational product m

[12] The investigational drug must be undergoing active development or ongoing production and may not be discontinued by the manufacturer or placed on clinical hold.[13] Eligible investigational drugs are exempt from: Statute or Regulation[14] Description FD&C § 502(f) Adequate directions for use; label warnings FD&C § 503(b)(4) Misbranding FD&C § 505(a) Drug approval FD&C § 505(i) Investigational drug exemption PHSA § 351(a) Biologics license requirements 21 C.F.R. Part 50 Protection of human subjects 21 C.F.R. Part 56 Institutional review board oversight 21 C.F.R. Part 312 Investigational new drug requirements However, sponsors of eligible investigational drugs must comply with: Regulation[15] Description 21 C.F.R. § 312.6 Labeling of an investigational new drug 21 C.F.R. § 312.7 Prohibition on investigational drug promotion 21 C.F.R. § 312.