Secondary Patenting of Branded Pharmaceuticals
October 10, 2012 | Journal Article
This article examines how secondary patents can extend market exclusivity and thus delay generic competition.
Prescription Drugs and Services
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The Food and Drug Administration Has The Legal Basis to Restrict Promotion of Flawed Comparative Effectiveness Research
October 8, 2012 | Journal Article
Under FDA policy, communications by prescription drug manufacturers must be backed by “substantial evidence” from “adequate and well-controlled investigations.” But numerous exceptions permit manufacturer promotion based on data other than randomized trials.
User Fees and Beyond
October 4, 2012 | Journal Article
This perspective examines the Food and Drug Administration (FDA) Safety and Innovation Act (FDASIA) of 2012.
Ethical Considerations in Orphan Drug Approval and Use
August 1, 2012 | Journal Article
While the 1983 Orphan Drug Act led to a boom in development and production of orphan drugs, inattentive regulatory standards may imperil patients with rare diseases.
Fair and Transparent Drug Company Practices Needed to Protect Consumers
October 12, 2012 | Story
Drug patent reform and legal restrictions on pharmaceutical company advertising are explored in an RWJF Investigator’s latest research.
In a Survey, Marked Inconsistency in how Oncologists Judged Value of High-Cost Cancer Drugs in Relation to Gains in Survival
April 1, 2012 | Journal Article
Amid calls for physicians to become better stewards of the nation's health care resources, it is important to gain insight into how physicians think about the cost-effectiveness of new treatments.
Use of Prescription Drug Samples and Patient Assistance Programs, and the Role of Doctor¿Patient Communication
December 1, 2011 | Journal Article
Study found use of free drug samples widespread among older adults but participation in pharmaceutical industry-sponsored patient assistance programs very low.
An Empirical Review of Major Legislation Affecting Drug Development
September 1, 2011 | Journal Article
Using market exclusivity to promote pharmaceutical innovation can lead to positive outcomes, but the practice is also characterized by waste and collateral effects.
New on the Human Capital Web Site: RWJF Investigator Awardee Takes Closer Look at Market Incentives for Drug Manufacturers
January 6, 2011 | Human Capital Blog Post
To casual observers, two facts about the U.S. pharmaceutical industry seem to be at odds. On one hand, the industry as a whole is very profitable: It had a 2008 profit margin of 19 percent, and it is regularly at or near the top of Fortune 500 ranki ...
Designing Comparative Effectiveness Research on Prescription Drugs
October 1, 2010 | Journal Article
As comparative effectiveness research becomes a more prominent feature of clinical medicine, investigators and policy-makers would do well to seek lessons from prior examples of this type of research.