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Ex-FDA Head and Sanofi Call for Harmonized Drug Regulation


May 11, 2016

By Ben Hirschler

LONDON - Drug regulation has failed to keep up with a globalized world and governments should harmonize oversight to improve patients' access to new and innovative medicines.

That is the view of the former leader of the U.S. Food and Drug Administration (FDA), the world's top drug regulator, and the research head of French drugmaker Sanofi, who made a joint plea to governments for action on Wednesday.

Margaret Hamburg, who led the FDA until 2015, and Elias Zerhouni said there was an urgent need to harmonize a "mosaic of regulations" in different countries, and they called for the issue to be taken up at the G8 or G20 groups of nations.

"We would challenge governments, including congresses and parliaments, presidents and prime ministers, to put harmonization on their agenda," they write in an editorial in the journal Science Translational Medicine, May 11.

Currently, drug regulation is a local affair with agencies such as the FDA and the European Medicines Agency (EMA), plus similar bodies in other countries, acting as gatekeepers to national markets.

Cooperation between agencies has increased but this has not kept up with globalization, which has blurred the distinctions between foreign and domestic medicines.

Nearly 40 percent of drugs used by Americans, for example, are made elsewhere and 80 percent of the active pharmaceutical ingredients in them are manufactured overseas.

The current system is simply at odds with the nature of the supply chain, said Zerhouni, who is also a previous director of the U.S. National Institutes of Health.

"Essentially, it is a hidden bureaucratic inefficiency tax on the whole effort of finding new and valuable therapies," he said in a telephone interview.

"Drug development is global and we need to have safety and efficacy data globally, so we should have a global system, just like with airplanes."

Zerhouni said Sanofi was spending around 20 percent of its research and development budget on ensuring convergence between different systems, often involving duplication of efforts.

Even so, there can still be big gaps, as with Sanofi's new dengue fever vaccine, the first in the world, which will not be available for years in the world's two most populous markets, China and India, because of demands for separate clinical trials.

"The regulation of drugs can either grease the wheels of progress or throw a wrench in the works," Hamburg and Zerhouni concluded. "We believe that harmonized drug regulation has the potential to be the unsung hero in driving improved health along with global economic and social development."

SOURCE: http://bit.ly/1Oiyaew

Sci Transl Med 2016.

 

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