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.
False Claims Act Prosecution Did Not Deter Off-Label Drug Use in the Case of Neurontin
December 1, 2011 | Journal Article
Since 2004 the United States has collected approximately $8 billion from fraud enforcement actions against pharmaceutical manufacturers accused under the federal False Claims Act of illegally promoting drugs for off-label uses.
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.
Using a Drug Facts Box to Communicate Drug Benefits and Harms
April 21, 2009 | Journal Article
This article examines whether providing a drug facts box on direct-to-consumer advertising can impact consumer understanding and decision-making.
Public Preferences and Organized Interests in Health Policy
February 1, 2007 | Journal Article
Congress debated a bill on adding prescription drug coverage to Medicare for nearly a decade and passed an inadequate plan in 2003,
State-Run Rx Programs for Low-Income Seniors in Illinois and Wisconsin Show how Differences in Coverage Affect Enrollment, Rx Use and Spending
March 6, 2008 | Program Result
Researchers at Brandeis University used data from two state-run prescription drug programs for low-income seniors to examine how differences in prescription drug coverage affect enrollment, drug use and spending in state programs.
Recommendations for FDA to Meet Needs of Small Populations Suffering Serious Diseases in Manhattan Institute White Paper
December 1, 2007 | Program Result
The Manhattan Institute for Policy Research released a white paper with recommendations on how to reform the pipeline for new medications, including the approval process by the Food and Drug Administration (FDA).
State Attempts to Contain Medicaid Prescription Costs Need More Hard Data
January 1, 1997 | Program Result
From 1992 to 1995, researchers at Harvard Medical School collected a comprehensive cross-section of data on state Medicaid pharmaceutical programs and various models of cost-containment. They also investigated the impacts of five cost-containment methods.