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"The NBER Bulletin on Aging and Health provides summaries of publications like this. You can sign up to receive the NBER Bulletin on Aging and Health by email. The US Food and Drug Administration (FDA) expends considerable efforts in regulating medications approved for use. Yet the impact of medication labeling changes on brand pharmaceutical products, and whether and what firms do to respond to increased information regarding the safety and efficacy of a drug, have not be characterized. We propose a behavioral framework for examining the effects of FDA advisories on branded pharmaceutical firms and their products. We empirically assess the impact of recent FDA advisories on the stock market valuations of a sample of branded pharmaceutical manufacturing firms using event study methods. We examine whether and how branded pharmaceutical manufacturers respond to an advisory by assessing changes in promotion compared to non-affected firms. We find firms targeted by an advisory have average stock price declines of 3% in three days and 11% in five days following the advisory release, and in turn appear to decrease total physician-directed promotion spending, journals ads and detailing visits significantly six months following the advisory release; the provision of free samples is unaffected. We find no changes among therapeutic substitutes unaffected by the advisory. Results of sensitivity analyses suggest firms with market dominant positions experience similar decreases in stock market valuations and physician-directed promotion compared to pooled results. The results are also robust to alternative definitions of the timing of advisory release dates and the severity of advisories' wording. Theory and empirical results suggest the public release of FDA advisories negatively impacts firm's short-term market valuations. The results suggest an additional rationale for previously documented declines in prescribing after FDA advisory releases - significant declines in physician-directed promotion following FDA advisory releases; the combined (and likely correlated) effects of the release of the advisory and declines in physician-directed promotion on prescribing behavior are likely larger than the sum of the independent effects"--National Bureau of Economic Research web site

Treating patients with cancer with infused or injected oncolytics is a core component of outpatient oncology practice. Currently, practices purchase drugs and then bill insurers, colloquially called "buy and bill." Reimbursement for these drugs is the largest source of gross revenue for oncology practices, and as the prices of cancer drugs have grown over time, these purchases have had significant impact on the financial health of practices and pose a risk that jeopardizes the ability of many practices to operate and provide patient care. Medicare Part B spending on drugs is under political scrutiny because of federal spending pressures, and the margin between buy and bill, lowered to 6% by the Medicare Modernization Act and further decreased to 4.3% by sequestration, is a convenient and popular target of budgetary discussions and proposals, scored to save billions of dollars over 10-year budget windows for each percentage-point reduction. Alternatives to the buy-and-bill system have been proposed to include invoice pricing, least costly alternative reimbursement, bundling of drugs into episode-of-care payments, shifting Part B drugs to the Medicare Part D benefit, and revision of the failed Competitive Acquisition Program. This article brings the perspectives of policy makers, health care economists, and providers together to discuss this major challenge in oncology payment reform.