Now showing items 1-10 of 13
Does generic entry always increase consumer welfare?
(Food Drug Law J, 2012)
This article examines how the nature of competition between brands in a therapeutic category changes after generic entry and provide a framework for analyzing the effect of generic entry on consumer welfare that takes into ...
Regulatory and cost barriers are likely to limit biosimilar development and expected savings in the near future.
(Health Aff (Millwood), 2014-06)
In March 2010 Congress established an abbreviated Food and Drug Administration approval pathway for biosimilars-drugs that are very similar but not identical to a reference biological product and cost less. Because bringing ...
Should the patent system for new medicines be abolished?
(Clin Pharmacol Ther, 2007-11)
The distribution of sales revenues from pharmaceutical innovation.
OBJECTIVE: This report updates our earlier work on the returns to pharmaceutical research and development (R&D) in the US (1980 to 1984), which showed that the returns distributions are highly skewed. It evaluates a more ...
The price of innovation: new estimates of drug development costs.
(J Health Econ, 2003-03)
The research and development costs of 68 randomly selected new drugs were obtained from a survey of 10 pharmaceutical firms. These data were used to estimate the average pre-tax cost of new drug development. The costs of ...
Economic return of clinical trials performed under the pediatric exclusivity program.
CONTEXT: In 1997, Congress authorized the US Food and Drug Administration (FDA) to grant 6-month extensions of marketing rights through the Pediatric Exclusivity Program if industry sponsors complete FDA-requested pediatric ...
Evolving brand-name and generic drug competition may warrant a revision of the Hatch-Waxman Act.
(Health Aff (Millwood), 2011-11)
The evolution of pharmaceutical competition since Congress passed the Hatch-Waxman Act in 1984 raises questions about whether the act's intended balance of incentives for cost savings and continued innovation has been achieved. ...
Returns to R&D on new drug introductions in the 1980s.
(J Health Econ, 1994-12)
This study finds that the mean IRR for 1980-84 U.S. new drug introductions is 11.1%, and the mean NPV is 22 million (1990 dollars). The distribution of returns is highly skewed. The results are robust to plausible changes ...
Spending on postapproval drug safety.
(Health Aff (Millwood), 2006-03)
Withdrawals of high-profile pharmaceuticals have focused attention on post-approval safety surveillance. There have been no systematic assessments of spending on postapproval safety. We surveyed drug manufacturers regarding ...