FDA Abroad - Pharmaceutical Executive

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FDA Abroad


Pharmaceutical Executive

In 2008, FDA sent its first inspectors to live and work full time in global markets, where active pharmaceutical ingredients (API)—and finished drug products—to be used by US patients, are increasingly being manufactured and exported.

That project has since expanded to 11 international offices, but the current level of permanent staffing in some regions is unbelievably, if not terrifyingly small: between 2008 and 2013, just one policy analyst and one inspector worked full time in China, for example, although that number has grown to 11 locally-based drug investigators in 2014, said Christopher Hickey, director at FDA's China office, at DIA's annual meeting last month. Given the fact that China exported $3.25 billion in API to the US last year, up from $410 million 15 years ago, it's in some ways surprising that American patients haven't endured other large-scale adulterations along the lines of the Heparin debacle, which killed 80 people in 2008.




In India, America's second largest global source of API and finished drug products, some 1,965 manufacturing facilities export to the US, but only around 600 sites are registered with CDER, said Atul Agrawal, supervisory consumer safety officer at FDA's India office. Drug manufacturing capability in India doubled to represent 12% of total US drug imports in 2012, up from 6% in 2008. "India is a major player in the prescription drugs Americans take on a daily basis," said Agrawal, much to the envy of Chinese nationals everywhere. And yet, FDA's operation in India currently consists of five full-time Americans, and two locally employed staffers, spread across two offices, one in New Delhi and one in Mumbai.

As a result, FDA officials in China, India, Latin America, and elsewhere are working tirelessly to form partnerships with "competent authorities" in local governments, to extend the reach of manufacturing inspections. Progress is being made, and the 2012 passage of The Food and Drug Administration Safety and Innovation Act contained critical provisions designed to improve the integrity of imported drugs sold in the US, FDA speakers said. In May 2014, FDA announced the Mutual Reliance Initiative, in cooperation with the European Commission (EC) and the European Medicines Agency (EMA), which aims to deepen the information exchange between inspectors to promote higher quality exports and better manufacturing practices.

Challenges remain: reporting structures within foreign governments can be labyrinthine, inspection protocols vary, training is expensive, and economically-motivated adulteration of products, and records, is still in play. In many places, said Michael Rogers, regional director of FDA's Latin America office, additional governmental clearance requirements block out FDA personnel entirely: "We have no information or inspectors" in these places, which means FDA "must partner," or simply hope, blindly, that any problems get sorted stateside, before they end up in a pill bottle or an injection.

FDA officials willing to relocate, often with their families, to far-flung global cities (on modest salaries) ought to be congratulated for their herculean efforts to protect American patients. Patients themselves, particularly those who vote for politicians running on platforms touting lower taxes, economic globalization, and funding cuts to government agencies, ought to be careful who they blame when the next round of adulterated medicine shows up in a loved one's medicine cabinet.








Ben Comer is Pharm Exec's Senior Editor. He can be reached at
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