Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad (2012) / Chapter Skim
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1 Introduction
1 Introduction
Pages 13-32
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From page 13... ...
Figure 1-3 shows the path tunafish may travel to reach an American supermarket, and Figure 1-4 describes a modern drug supply chain and the many potential points of vulnerability. As the FDA's Pathway to Global Product Safety and 13
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From page 14... ...
The Global Health Strategy marks a departure from the traditional conception of HHS and its agencies, including the FDA, as purely domestic organizations with an almost exclusively domestic focus. For the FDA in particular, the new HHS strategy aims to "strengthen regulatory capacity on a global basis.
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1-2a Imports of FDA-regulated products market, 1998 Estimate FIGURE 1-2 Increases in global trade are increasing the exposure of U.S. consumers to foreign products and source materials.
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The changes put forth in Pathway to Global Product Safety and Quality and the HHS Global Health Strategy are the culmination of a gradual shift in the FDA's way of operating, the ramifications of which might not yet be widely recognized, as the American regulatory system moves from mainly reacting to crises to preventing them (Olson, 2011)
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Fake raw materials enter National & the herapin supply chain, Regional associated with adverse Inactive Wholesalers events including death Ingredients FINAL Hospitals & Pharmacies PRODUCT Raw Active Materials Ingredients Smaller Wholesalers Medicaid drugs dispensed to patients are resold into distribution Ingredients from unknown sources sold as if Epogen® relabeled by a counterfeiter made at approved plants to resemble a higher strength enters distribution and reaches patients FIGURE 1-4 In complex global drug supply chains, there are many opportunities for unsafe products to be introduced before reaching the consumer. Figure reprinted with permission from the PEW Health Group.
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FIGURE 1-5 The HHS's Global Health Strategy lays out three interconnected goals.
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The FDA commissioned this report to advance its global mission and promote the necessity of working across borders for product safety. CHARGE TO THE COMMITTEE This report, the HHS Global Health Strategy, and the FDA's Pathway to Global Product Safety and Quality draw on a common implicit conceptual framework: no country protects its citizens by working alone.
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Identifying the core elements of needed pharmaceutical, biologics, medical device, and food safety regulatory systems development in developing countries; and in (B) Prioritizing these needs and recommending a strategic approach to the FDA's moving forward to address regulatory capacity needs in the context of globalization.
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What critical issues do developing country regulatory authorities face, and how are they prioritized?
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Both the Food Safety Modernization Act and the FDA's Pathway to Global Product Safety and Quality emphasize collaboration between the FDA and its counterpart agencies abroad (Tanne, 2011)
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Public testimonies and information provided to the committee by vari ous stakeholders informed its deliberations, the content of this report, and the committee's recommendations to the FDA and other organiza tions as to how they can build capacity for food and medical product regulation around the world. After hearing public testimony and identify ing the main product safety problems in developing countries, the com mittee and IOM staff examined these problems in the published literature, including scientific studies, commentaries, new articles, and books.
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This is a complicated problem, but by no means a new one. In its analysis of the core elements of a food and medical products regulatory system, the committee gained perspective by first considering how one gold-standard regulatory agency evolved over the past century.
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Only 4 months after the book's publication, during which time President Roosevelt sent inspectors to verify Sinclair's portrayal of stock yards and slaughterhouses, Congress passed the Pure Food and Drug Act and the Meat Inspection Act, banning food adulteration, deceptive statements on labels, and the interstate sale of adulterated foods (Jackson, 2009)
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Massengill Company responded to demand for a liquid sulfa drug preparation with the so-called Elixir Sulfanilamide, a solution of caramel, raspberry extract, water, and the drug sulfanilamide dissolved in diethylene glycol (Ballentine, 1981; Wax, 1995)
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1906 President Theodore Roosevelt signs the Pure Food and Drug Act and Meat Inspection Act into law. The laws ban food adulteration, deceptive labels, and the interstate sale of illegal food and drugs.
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. In 2008 New York Times reporters Walt Bogdanich and Jake Hooker won the Pulitzer Prize for their investigative series, "A Toxic Pipeline," that tracked adulterated medicine from China to Panama, where over-the-counter cough syrup mixed with diethylene glycol killed hundreds (Bogdanich and Hooker, 2007; The Pulitzer Prizes, 2008)
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. In an interview with Voice of America, WHO food safety scientist Peter Ben Embarek attributed much of the problem to a lag between private-sector production capability and the public sector's ability to regulate (Schlein, 2008)
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Chapter 6 recommends domestic action that could improve the capacity of food and medical product regulation around the world. Chapter 7 discusses which of the recommendations can be implemented in 3 to 5 years and the report's consistency with the objectives outlined in the Global Health Strategy.
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Addressing the challenges of medical device safety in a global environ ment. Presented at Strengthening Core Elements of Regulatory Systems in Developing Countries: Meeting One, Institute of Medicine, Washington, DC.
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2011. FDA seeks global partners to improve safety of imported food, medicines, and devices.
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