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Anup Malani

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Full-Text Articles in Law

Improving The Fda Approval Process, Anup Malani Mar 2010

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 …


Rational Crises, Anup Malani, Albert Choi Feb 2008

Rational Crises, Anup Malani, Albert Choi

Anup Malani

The paper engages the ongoing debate among scholars such as Cass Sunstein, Max Bazerman and Richard Posner about why governments fail to take action to prevent crises such as Hurricane Katrina and global warming. Standard explanations rely on public choice theories (specifically collective action problems or conflicts between interest groups) or on cognitive limitations (such as hyperbolic discount rates or the inability to value low-probability events). In contrast, we offer a simple rational-choice explanation. The government may not act on information about a forthcoming crisis because there are many lobbies (including government agencies) seeking funding to address their selected crisis …


Regulation With Placebo Effects, Anup Malani Feb 2008

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 …