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Independent research & practical ideas for global prosperity
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Independent research & practical ideas for global prosperity
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 Posts:February 12, 2010FDA Goes Global: A New Approach to Food and Drug Import SafetyBy Tom Bollyky
Last week, I participated in an event at the Center for Strategic and International Studies (CSIS) in which U.S. Food and Drug Administration (FDA) Commissioner Margaret Hamburg announced a remarkable shift in the FDA’s thinking on food and drug import safety. If adequately supported by Congress and translated into concrete action, this change in strategy on food and drug safety could have significant benefits for U.S. and global health and development. Read More… 1 Comment »August 27, 2009Potential U.S. Supreme Court Case on Nigerian Drug Trial Presents Mixed Picture for Global HealthBy Tom BollykyA still from the movie “The Constant Gardener,” starring Rachel Weisz and based on the book by John le Carre, which was reportedly inspired by the Pfizer case. In 1996, Pfizer conducted a clinical trial of Trovan, a new antibiotic, on children during an outbreak of bacterial meningitis in Kano, Nigeria. Eleven children died and others were left badly injured, according to trial participants. In 2001, 30 Nigerian families sued in U.S. federal court, arguing that Pfizer deviated from its clinical trial protocol and failed to inform the children or their guardians of Trovan’s life-threatening side effects or that Médecins Sans Frontières was providing the conventional, proven treatment for bacterial meningitis for free at the same site. Pfizer has denied wrongdoing. Years of litigation followed over whether the case should be heard in U.S. courts. Earlier this year, a U.S. appeals court ruled that the Pfizer case could proceed. The U.S. Supreme Court is now deciding whether to hear the Pfizer case. If the Court hears the case, and there is a good chance it will, the Court will be asked to decide two important questions: (1) whether Pfizer acted in sufficiently close concert with the Nigerian government to be considered a “state actor” and, thus, possibly liable under the U.S. Alien Tort Statute (ATS) and (2) whether nonconsensual human medical experimentation violates customary international law. These questions sound pretty technical, but the Court’s answers could have significant practical implications for corporate responsibility, development, and global health. Read More… 11 Comments »August 20, 2009A Promising Senate Initiative on Neglected DiseasesBy Tom BollykyEarly this month the U.S. Senate passed an amendment to pending legislation that has the potential to strengthen and streamline regulations governing the clinical testing of drugs for neglected diseases in the developing world. The targeted diseases include malaria and TB, which annually kill an estimated 2.5 million people in the developing world, plus scores of diseases you may have never heard of (such as Chagas disease and leishmaniasis), but that nonetheless exact a large and lethal toll, especially on children and poor people in developing countries. Senator Sam Brownback, a Republican from Kansas, introduced the amendment to the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act of 2010. As Senator Brownback explained: Read More… 6 Comments »August 12, 2009Terminology Matters: The Dispute between India and EU over Generic Drug TransshipmentsBy Tom BollykyOver the last sixteen months, EU customs officials have impounded more than 20 shipments of pharmaceutical products manufactured by Indian companies. The EU maintains these seizures were intended to prevent trade in counterfeit medicines. India argues the EU is targeting developing country drug manufacturers and undermining access to lawful, safe, and low-cost generic drugs in developing country markets. Last week, India announced plans to seek settlement of the dispute at the World Trade Organization (WTO). The legal merits of the EU’s actions and India’s potential WTO claims are interesting questions. The more important issue for global health, however, is that disputes such as this one may be undermining international efforts to combat the trade in counterfeit medicines and the environment for legitimate generic products in developing countries. 3 Comments »July 10, 2009Drug Marketing Push in Developing Countries Has Upside and Potential Downside for Poor PeopleBy Tom BollykyThe Wall Street Journal published an article on Tuesday, entitled “Drug Firms See Poorer Nations as Sales Cure,” that raises important issues about international on-patent drug pricing and the sustainability of drug access in poor market segments of developing countries. Read More… 4 Comments » |
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