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.
In Medicare Part D Plans, Low or Zero Copays and Other Features to Encourage the Use of Generic Statins Work, Could Save Billions
October 1, 2012 | Journal Article
This study examines how different drug plan benefit and formulary designs influence the selection of generic drugs to treat high cholesterol among Medicare beneficiaries.
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.
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.
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.
A Decade of Controversy
November 12, 2009 | Journal Article
Direct-to-consumer advertising (DTCA) of prescription drugs has remained controversial since regulations were liberalized by the FDA in 1997. This study reviewed empirical evidence addressing the claims made in the policy debate for and against DTCA.
Lost in Transmission
October 21, 2009 | Journal Article
This commentary calls for prescription medication labels to more accurately reflect FDA review documents. The FDA is considering adopting "Prescription Drug Facts Boxes" to supply crucial information now absent from many drug labels.