Assuring Drug Safety in a Global World

Margaret Hamburg tells British regulators she’s having a little trouble sleeping at night

By Steven E. Kuehn

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With the advent of the Food and Drug Administration’s Safety and Innovation Act (FDASIA), the Agency created new authority to regulate foreign suppliers of raw materials and active pharmaceutical ingredients (APIs) in an attempt to provide drug consumers, many in the United States, access to safe and effective pharmaceuticals from sources that are increasingly global in nature.

As contributor Angelo DePalma notes in this issue’s cover piece “FDA’s Fast-Track Agenda,”  the FDA can no longer ignore malfeasance simply because it occurs outside its territorial jurisdiction. Citing examples of highly publicized drug marketing corruption uncovered in China recently, DePalma posits that “developing countries are beginning to take corruption seriously. Or conversely these incidents unveil even deeper malfeasance.” Traditionally it’s been the FDA’s purview (and to a lesser degree the U.K., notes a DePalma source) to provide global oversight of clinical data integrity, manufacturing conduct and quality assurances — however, the effectiveness of this oversight is increasingly being challenged by the globalization of the pharmaceutical supply chain.

Margaret Hamburg, FDA’s commissioner of Food and Drugs, recently addressed the Medicines and Healthcare Products Regulatory Agency (MHRA) at its Annual Lecture. Characterizing her relationship as a “special kinship” with British regulators, Hamburg’s remarks quickly turned to the purpose of her speech, which was to address “a topic of great — and growing — importance: globalization.” Although, she said, there are many benefits to globalization, our dramatically transforming world is generating huge implications for health, medicine and the role of the regulators.

“Frankly,” said Hamburg, “this is an issue that keeps me up at night.” Conceding that addressing the challenge of globalization was not something she expected to take on when she came to the FDA five years ago, she explained that “it has been a priority since the very beginning because the needs are so glaringly obvious … and urgent.”

The rise of global markets and supply chains has indeed been dramatic. Hamburg noted that 40 percent of finished drugs Americans consume are made elsewhere — potentially from more than 150 countries — many with less sophisticated regulatory systems.

“At every step in global supply chain networks — from raw materials and other ingredients, to manufacture, storage, sale and distribution — there are opportunities for a product to be improperly formulated or packaged, contaminated, diverted, counterfeited or adulterated,” said Hamburg, advocating that inspection-based regimes are no longer adequate to assure quality and safety and that the more effective course is to focus on preventing problems before they reach our borders by strengthening quality and safety oversight in countries from which countries like the U.S. and the U.K. import pharmaceuticals. This is coming at a time, she said, when regulators are struggling to keep up with transparency in regulatory agency operations, including “an often skeptical or frankly hostile attitude towards regulation.” That last remark is troubling, but likely offered to characterize the state of regulatory affairs in emerging markets where regulation is less entrenched culturally.

Her remarks continued to lay out a strong case as to why regulators around the world need to up their game. Clearly obvious in her comments were appeals to foster collaboration and cooperation among the global community of regulators, as well as a call to action for manufacturers who actually need to carry most of the water when it comes to assuring the safety of the global drug supply. How does one assure drug safety globally? “At the FDA we think it means that,” said Hamburg, “we must have more than just a presence around the world — though we surely must strengthen and extend that. It means engaging internationally with our counterpart … authorities and with the industries we regulate in a multinational fashion. Only in this way will we be able to ensure the integrity of the global supply chain …” My take away? Better get your rest, Margaret.

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