Legislative efforts to establish an abbreviated regulatory approval pathway for follow-on biologics (FOBs), also referred to as biosimilars, have generated considerable attention and debate. Legislators expect FOBs to produce cost savings through competition, much like that seen in the U.S....

Food and Drug Administration (FDA) drug advisory committee members sometimes have financial interests tied to drug companies. Congress and the public have become concerned that these financial interests lead to conflicts of interest. They conclude that the conflicts bias committee...

Food and Drug Administration (FDA) drug advisory committee members sometimes have financial interests tied to drug companies. Congress and the public have become concerned that these financial interests lead to conflicts of interest. They conclude that the conflicts bias committee...

In this article we describe how reimbursement cost-effectiveness thresholds, per unit of health benefit, whether set explicitly or observed implicitly via historical reimbursement decisions, serve as a signal to firms about the commercial viability of their R&D projects (including candidate...

This paper uses national data for the period 1960 to 2000 to estimate an aggregate private consumer demand for pharmaceuticals in the U.S. The estimated demand curve is then used to simulate the value of consumer surplus gains from a drug price control regime that holds drug price increases to...

EU countries closely regulate pharmaceutical prices whereas the U.S. does not. This paper shows how price constraints affect the profitability, stock returns, and Ramp;D spending of EU and U.S. firms. Compared to EU firms, U.S. firms are more profitable, earn higher stock returns, and spend more...

Political pressure in the United States is again building to constrain pharmaceutical prices either directly or through legalized reimportation of lower-priced pharmaceuticals from foreign countries. This study uses the Clinton Administration's Health Security Act (HSA) of 1993 as a natural...

Do threats of pharmaceutical price regulation affect subsequent Ramp;D spending? This study uses the Clinton Administration's Health Security Act (HSA) of 1993 as a natural experiment to study this issue. We link events surrounding the HSA to pharmaceutical stock price changes and then examine...