Evidence and Extrapolation: Mechanisms for Regulating Off-Label Uses of Drugs and Devices

A recurring, foundational issue for evidence-based regulation is deciding whether to extend governmental approval from an existing use with sufficient current evidence of safety and efficacy to a novel use for which such evidence is currently lacking. This extrapolation issue arises in the medicines context when an approved drug or device that is already being marketed is being considered (1) for new conditions (such as off-label diagnostic categories), (2) for new patients (such as new subpopulations), (3) for new dosages or durations, or (4) as the basis for approving a related drug or device (such as a generic or biosimilar drug). Although the logic of preapproval testing and the precautionary principle—first, do no harm—would counsel in favor of prohibiting extrapolation approvals until after traditional safety and efficacy evidence exists, such delays would unreasonably sacrifice beneficial uses. The harm of accessing unsafe products must be balanced against the harm of restricting access to effective products. In fact, the Food and Drug Administration\u27s (FDA\u27s) current regulations in many ways reject the precautionary principle because they largely permit individual physicians to prescribe medications for off-label uses before any testing tailored to those uses has been done. The FDA\u27s approach empowers physicians, but overshoots the mark by allowing enduring use of drugs and devices with insubstantial support of safety and efficacy. This Article instead proposes a more dynamic and evolving evidence-based regime that charts a course between the Scylla and Charybdis of the overly conservative precautionary principle on one hand, and the overly liberal FDA regime on the other. Our approach calls for improvements in reporting, testing, and enforcement regulations to provide a more layered and nuanced system of regulatory incentives. First, we propose a more thoroughgoing reporting of off-label use (via the disclosure of diagnostic codes and detailing data) in manufacturers\u27 annual reports to the FDA, in the adverse event reports to the FDA, in Medicare/Medicaid reimbursement requests, and, for a subset of FDA-designated drugs, in prescriptions themselves. Second, we would substantially expand the agency\u27s utilization of postmarket testing, and we provide a novel framework for evaluating the need for postmarket testing. Finally, our approach calls for a tiered labeling system that would allow regulators and courts to draw finer reimbursement and liability distinctions among various drug uses, and would provide the agency both the regulatory teeth and the flexibility it presently lacks. Together, these reforms would improve the role of the FDA in the informational marketplace underlying physicians\u27 prescribing decisions. This evolutionary extrapolation framework could also be applied to other contexts

A Roadmap to Reduce U.S. Food Waste by 20 Percent

The magnitude of the food waste problem is difficult to comprehend. The U.S. spends $218 billion a year -- 1.3% of GDP -- growing, processing, transporting, and disposing of food that is never eaten. The causes of food waste are diverse, ranging from crops that never get harvested, to food left on overfilled plates, to near-expired milk and stale bread. ReFED is a coalition of over 30 business, nonprofit, foundation, and government leaders committed to building a different future, where food waste prevention, recovery, and recycling are recognized as an untapped opportunity to create jobs, alleviate hunger, and protect the environment -- all while stimulating a new multi-billion dollar market opportunity. ReFED developed A Roadmap to Reduce U.S. Food Waste as a data-driven guide to collectively take action to reduce food waste at scale nationwide.This Roadmap report is a guide and a call to action for us to work together to solve this problem. Businesses can save money for themselves and their customers. Policymakers can unleash a new wave of local job creation. Foundations can take a major step in addressing environmental issues and hunger. And innovators across all sectors can launch new products, services, and business models. There will be no losers, only winners, as food finds its way to its highest and best use

Pathways to Disability Income among Persons with Severe, Persistent Psychiatric Disorders

[Excerpt] Harsh skepticism pervades current public debate about who deserves public support and on what basis, particularly regarding the claims of individuals with disabling illness and injury. Heretofore, these claims were accepted, even reservedly, and the needs of such individuals were considered to be legitimate even when they were monitored closely. The Supplemental Security Income (SSI) and Social Security Disability Insurance (SSDI) programs and their recipients have been among the most visible and vulnerable targets of increased scrutiny and shrinking public beneficence. In 1997, congressional legislation redefined SSI eligibility for children, sparked largely by concerns that children have been deployed to engage in a type of public begging by acting crazy in order to secure benefits for their families. Maladaptive behaviors was removed from the mental disorder listings, and the Social Security Administration (SSA) estimates that 135,000 children will lose their benefits after review. In March 1996, Congress eliminated SSI, SSDI, Medicare, and Medicaid benefits for persons whose drug addiction or alcoholism is a prominent cause of disability, and as a result 141,000 recipients have been terminated. The SSA also was ordered to begin another sweeping review of all recipients of disability income. SSA officials reportedly expect this process to produce a termination rate of 14 percent, resulting in an estimated 196,000 additional individuals who would cease to receive SSI and SSDI

THE ROLE OF PRODUCT ATTRIBUTES IN THE AGRICULTURAL NEGOTIATIONS

Marketing, International Relations/Trade,

ECOLABELS: THE LINK BETWEEN ENVIRONMENTAL PREFERENCES AND GREEN PRACTICES?

Ecolabels, food labeling, consumer preferences, Environmental Economics and Policy,