FDA review times have significantly declined since the passage of PDUFA in 1992, while agency resources have expanded through user fees. After the recent withdrawal of Vioxx and other high-profile products, there have been increasing concerns that PDUFA has adversely affected drug safety....

Patents for several blockbuster biological products are expected to expire soon. The Food and Drug Administration is examining whether biologics can and should be treated like pharmaceuticals with regard to generics. In contrast with pharmaceuticals, which are manufactured through chemical...

The 1984 Drug Price Competition and Patent Term Restoration Act (the Waxman-Hatch Act) is unique in many ways. This Law was the first change in U.S. patent terms since 1861. It simultaneously lowered the barrier to entry for generic drug firms and increased patent terms for new drugs delayed by...

The 1984 Drug Price Competition and Patent Term Restoration Act (the Waxman-Hatch Act) is unique in many ways. This Law was the first change in U.S. patent terms since 1861. It simultaneously lowered the barrier to entry for generic drug firms and increased patent terms for new drugs delayed by...

Pharmacy benefit management companies (PBMs) have emerged over the past decade in response to increased demand for health care cost containment. The ability to obtain volume rebates from drug manufacturers was the principle value added by the PBM industry during the early 1990s. However, PBM...

The focus of this paper is the economics of the pharmaceutical R&D process. Major developments currently impacting the industry include the fact that R&D costs for new drugs are rising very rapidly. Product life cycles are also shortening, meaning there is less time to recover R&D costs and...

In this paper we examine generic competition and market exclusivity periods for pharmaceuticals experiencing their initial generic entry between 1995 and 2005. We find that generic competition has increased over several dimensions. First, an increasing number of drugs are subject to generic...