;   Medical Translation Insight: Drug and device globalization presents a global challenge - ForeignExchange Translations

Drug and device globalization presents a global challenge"Globalization is a fact of 21st century economic life", says FDA. But backing this statement with actions has proven difficult for the agency.

A few years ago, discussion around the Food and Drug Administration Globalization Act prompted a lot of outrage over lax overseas inspection practices. One Representative noted how she "was shocked to learn that for each overseas facility that exports drugs to the United States, FDA is able to complete an inspection only once every 8 to 12 years."

Unfortunately, calls for FDA to add overseas inspection staff went largely unanswered. In 2009, we wrote that:

...FDA has only 2 inspectors watching drug factories in China and that the EU inspects fewer than 19 Chinese pharma factories annually
Now, coping with the fact that U.S. imports of regulated products including medical devices, drugs, food and cosmetics have increased three-fold over the last decade, FDA is attempting not one but two paradigm shifts.

In a landmark agreement, FDA and generic drug manufacturers have found a way to fund FDA's inspections of overseas manufacturing plants every two years, i.e., the same frequency required of domestic plants. The New York Times covered this huge announcement over the weekend.

While this agreement has been in the works for a while, it now appears ready for passage. This will fundamentally change (read, speed up) the pace of foreign inspections.

Longer term, the agency is formulating a long-term global regulatory plan that relies less on regulators' own staff and more on data and resource sharing with other countries, FDA recently said in an article published in The Gray Sheet [subscription required].

But while FDA wants to create a "global coalition of regulators", the agency's international work has been limited - and remains superimposed on its old model of inspections-based oversight.

What's more, FDA is not the only regulator grappling with globalization challenges. And, like FDA, its counterparts around the world face are also hampered by insufficient resources to handle these challenges. The same Gray Sheet article quotes an FDA official saying that a "global problem like this requires a global solution and global responsibility".

Maybe it's just me but I won't hold my breadth for a speedy regulatory solution. Having manufacturers underwrite underwrite foreign inspections seems to be a much surer way to ensure quality in global supply chains.


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