From the Business Litigation Practice.
The “Right to Try” refers to the right of terminally or seriously ill patients to acquire investigational drugs without waiting for FDA approval. It grants these patients the right to access certain drugs, specifically those drugs that have completed only phase one of the FDA three-phase drug approval process. Advocates of the Right to Try contend that the decision to try an investigational drug should be between a patient and his or her physician and, thus, exclude the government, i.e., the FDA. Opponents support the FDA’s role in the drug approval and distribution process. The Right to Try debate boils down to one question: Who should decide whether a drug is too risky to try? By Marisa A. Trasatti & Sarah M. Grago
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