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This scrutiny manifests both in the requirement to obtain approval by the Food and Drug Administration prior to marketing a drug for a specific use or condition, and in FDA regulating updates to a drug’s conditions of use, including its labeling, to reflect new data and evolving clinical practices, including to expand the permissible uses of a drug or to add restrictions. [...] The Fifth Circuit’s ruling broadly jeopardizes the reliability of FDA’s original approvals of drugs, and the agency’s approvals of modifications to the conditions of their use. [...] The PI must include, among other things, a summary of essential scientific information needed for safe and effective use of the drug, the approved populations and condition(s) for which the drug may be prescribed, specifically the indication(s), details regarding approved dosage and methods of administration, a statement of warnings, precautions and drug interactions, and any other conditions requ. [...] FDA compares the data presented in support of a supplemental application to the data presented with the application for the initial approval 2 Changes that do not bear on the safety or effectiveness of a drug, including editorial label changes and the like, are not required to go through this process and may, in some cases, instead be included in an annual report to the agency. [...] The agency may also determine, independently of the drug sponsor, that modification of a REMS is necessary, for example to ensure that the benefits of a drug continue to outweigh its risks; in such cases, the agency has the authority to require the drug sponsor to submit a proposal for the necessary modification.