Open Access. Powered by Scholars. Published by Universities.®
Articles 1 - 3 of 3
Full-Text Articles in Law
Does Misery Love Company - Evidence From Pharmaceutical Markets Before And After The Orphan Drug Act, Frank R. Lichtenberg, Joel Waldfogel
Does Misery Love Company - Evidence From Pharmaceutical Markets Before And After The Orphan Drug Act, Frank R. Lichtenberg, Joel Waldfogel
Michigan Telecommunications & Technology Law Review
The possibility that small populations would see few medications developed for their conditions has [...] led the U.S. Congress to pass the 1983 Orphan Drug Act ("ODA"), giving firms special incentives to develop drugs for diseases afflicting fewer than 200,000 persons per year.[...][U]under the Act, drug makers receive seven years of exclusive marketing upon FDA approval of newly-developed drugs qualifying as "orphan drugs"--i.e., drugs for disorders affecting fewer than 200,000 persons.[...]Together, [the] provisions (a) increase the effective market size; and (b) reduce fixed (sunk) costs. In doing so, the Act provides a natural experiment for measuring the impact of increased …
Pdufa And Initial U.S. Drug Launches, Mary K. Olson
Pdufa And Initial U.S. Drug Launches, Mary K. Olson
Michigan Telecommunications & Technology Law Review
In the 1970s and 1980s, many pharmaceutical firms launched new drugs abroad prior to gaining U.S. approval. Consequently, U.S. patients often faced delays in accessing important new medicines. High regulatory barriers to entry, such as a stringent regulation and a lengthy drug review process, contributed to this problem. This Article examines the impact of the Prescription Drug User Fee Act (PDUFA), and subsequent increases in the speed of FDA review, on the likelihood of initial U.S. drug launches. These factors are hypothesized to lower regulatory barriers to entry in the U.S. pharmaceutical market. The results show that increased drug review …
Corporate Cooperation Through Cost-Sharing, Nicola Faith Sharpe
Corporate Cooperation Through Cost-Sharing, Nicola Faith Sharpe
Michigan Telecommunications & Technology Law Review
Applying a game-theoretic approach based on the classic prisoners' dilemma provides valuable insights into corporate managers' decision-making incentives under existing discovery rules. It demonstrates that the fee structure imposed by current discovery rules leads to inefficiency and motivates corporate litigants on either side of a controversy to employ abusive discovery practices, although each party would benefit from cooperation. Using this framework, this Article shows how a cost-sharing regime can motivate litigants to engage in cooperative discovery and, as a consequence, facilitate more efficient and less abusive discovery practices. To date, scholars, who have posited that cooperative behavior in the discovery …