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 firstname.lastname@example.org