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- W2894808219 abstract "Tb.is Article considers the _Restatement's_ approach of basing the determination on whether any separate class of patients benefits from the drug. For regulatory purposes, the Food and Drug.Adroiuist;ration (FDA) has considered a counterpart issue of whether a drug should ever be denied approval or be withdrawn when the drug is beneficial for some patients, but poses unreasonable risks when prescribed by physicians in ways contrary t,o label warnings. In dealing with this dilemma, theFDA has sought alternatives that will allow continued use of the product while reducing unreasonable risks to patients. These measures have included limits on the distribution of drugs and warnings to patients in addition to warnings to physicians. Although there are questions about the extent of the FDA's authority to limit the distribution of drugs, the approach of looking for alternatives to reduce risks has relevance for products liability purposes.The _Restatement's_ defect has been the subject of critical commentary that has primarily focused on whether a reasonable alternative design should be considered in determining whether a drug poses unreasonable risks and is thus defective, and whether the test should be based on the assessment of a reasonable manufacturer rather than a reasonable provider.The _Restatement's_ design test is discussed in Part II with respect to the rationale for not considering comparative designs. Part III discusses whether a product should ever be considered defective, even in the absence of an alternative design, because of the risk of misuse. In both sections, this Article considers the FDA regulatory system in evaluating the appropriateness of considering alternative designs, labeling changes, and other approaches to reduce risks." @default.
- W2894808219 created "2018-10-12" @default.
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- W2894808219 date "1999-10-01" @default.
- W2894808219 modified "2023-09-24" @default.
- W2894808219 title "When Drugs Are Safe for Some but Not Others: The FDA Experience and Alternatives for Products Liability" @default.
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