- Ex-FDA commissioner Margaret Hamburg, and Elias Zerhouni, who heads up Global R&D at Sanofi, laid out their arguments for advancing regulatory coordination in an editorial in Science Translational Medicine. The overall goal, according to these respected thought leaders, is to increase access to new medications to patients worldwide.
- The basis of their argument is that an unprecedented level of globalization has made the biopharma industry more unified and international than ever before, with 40% of drugs and 50% of medical devices in the US coming from abroad.
- The answer to the problem of perpetually backlogged approvals and the access challenges that come with them is greater regulatory harmonization--- coordinating and aligning regulatory rules accross nations -- they wrote.
Both Hamburg and Zerhouni are very experienced when it comes to dealing with the challenges of international regulatory challenges. Hamburg spend the last year of her tenure as FDA commissioner visiting various manufacturing sites in India and addressing the quality-related challenges that have plagued the country---which happens to be a major supplier of generics worldwide and a critical part of the international system.
For his part, Zerhouni has been an instrumental part of overseeing the development and approval of the Dengvaxia, the world's first vaccine against dengue fever. Although Dengvaxia is approved in Mexico, the Phillipines and Brazil, it will be years until it is approved in China and India, where dengue is endemic. Zerhouni is stymied by those countries' demands for separate clinical trials.
Those are two examples of a spate of problems that could be resolved with greater regulatory coordination. Hamburg and Zerhouni make the case that despite the many differences in regulatory frameworks informed by different histories, populations and national realities, the benefits of regulatory harmonization exceed the downsides.
There are existing organizations ,such as the International Council on Harmonization (ICH), the Pharmaceutical Inspection Convention and the Pharmaceutical Inspection Co-operation Scheme (PIC/S), which have made progress in advancing the goals of global harmonization---but its not enough. Recently, the International Coalition of Medicines Regulatory Authorities (ICMRA), a voluntary group of regulatory agency leaders, was formed to further advance these goals.
This letter represents another effort in a quest that has been ongoing since the ICH was formed in 1990. Even an incremental improvement in current global harmonization represents a significant step forward.