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Full-Text Articles in Law
Improving The Fda Approval Process, Anup Malani
Improving The Fda Approval Process, Anup Malani
Anup Malani
The FDA employs an average-patient standard when reviewing drugs: it approves a drug only if is safe and effective for the average patient in a clinical trial. It is common, however, for patients to respond differently to a drug. Therefore, the average-patient standard can reject a drug that benefits certain patient subgroups (false negative) and even approval a drug that harms other patient subgroups (false positives). These errors increase the cost of drug development – and thus health care – by wasting research on unproductive or unapproved drugs. The reason why the FDA sticks with an average patient standard is …
Regulation With Placebo Effects, Anup Malani
Regulation With Placebo Effects, Anup Malani
Anup Malani
There is a growing body of empirical evidence supporting the existence of placebo effects in medical contexts and is suggestive of nontrivial placebo effects in non-medical contexts. This paper reviews the literature on placebo effects, examines the implications for four fields of law (drug approval, informed consent law, consumer protection law, and torts) and suggests future areas for research on placebo effects. Specifically, it make the case for altering the drug approval process to account for, if not credit, placebo effects. It suggests allowing evidence of placebo effects as a defense in cases alleging violations of informed consent or false …