About this blog

CRITical Thinking is a blog written by staff, directors, and friends of the Collaboration for Research Integrity and Transparency (CRIT), a joint program of Yale Law School, Yale School of Public Health, and Yale School of Medicine. CRIT's mission is to promote health by improving the integrity and transparency of biomedical and clinical research. This blog is published by and reflects the personal views of the individual authors, in their individual capacities. It does not purport to represent Yale University's institutional views, if any. No representation is made about the accuracy of the information, which solely constitutes the authors’ personal views on issues discussed. The information contained in this blog is provided only as general information and personal opinions, and blog topics may be updated after being initially posted.

CRITical Thinking Blog

Work Locally, Coordinate Globally

February 22, 2018
By Joel Lexchin

I think that there are a number of problems that are common in all parts of the world. Among these are: the political and economic power of the pharmaceutical industry, the way that intellectual property rights interfere with access and affordability of medicines, the poor evidentiary base for the safety and effectiveness of many medicines and the increasing ties between regulators and industry, that result in the weakening of regulatory standards.

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Federal Judge Rules in FDA's Favor in Dispute Over Pediatric Exclusivity: A Win for the Agency, Patients, and Clinical Evidence

February 21, 2018
By Jeanie Kim, Amy Kapczynski, Joseph S. Ross

On February 17, 2018, a federal judge in the D.C. District Court affirmed the U.S. Food and Drug Administration's decision to deny a six-month extension of market exclusivity for Amgen's blockbuster drug cinacalcet (Sensipar).

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What Would a Pro-Patient, Pro-Public Health Regulatory System Look Like?

February 13, 2018
By Els Torreele

While we get many new products we don't need, major public health needs remain unmet.

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Seven Thoughts on the History and Present Practices of the FDA and Uses of Prescription Drugs

January 31, 2018
By Donald W. Light, Joel Lexchin

From before 1906, when the Pure Food and Drugs Act was passed, through the Vioxx crisis in 2004 to today, organized pharmaceutical lobbying has consistently tried to undermine Congressional efforts to protect patients from unsafe and ineffective drugs, often with considerable success.

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