Congress enacted and renewed the Prescription Drug User Fee Acts (PDUFA) in 1992, and renewed it in 1997 and 2002, mandating FDA performance goals in reviewing and acting on drug applications within specified time periods. In turn, the FDA was permitted to levy user fees on drug sponsors...

We generalize the stochastic specification to account for first-order vector autocorrelation in the system of portfolio demand equations and test for the validity of the "no autocorrelation" restrictions, in addition to the restricitions on the demand system implied by theory. When testing for...

The pricing of medical products and services in the U.S. is notoriously complex. In health care, supply prices (those received by the manufacturer) are distinct from demand prices (those paid by the patient) due to health insurance. The insurer, in designing the benefit, decides what prices...

"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. In this survey chapter on pricing and reimbursement in U.S. pharmaceutical markets, we first provide background information on important...

"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...