The recent announcement by the US Food and Drug Administration that it was setting up an office in China (see ePT story,”China, Here We Come”) was welcomed by many in the pharmaceutical industry.

FDA has been sharply criticized for its limited resources for inspecting foreign drug-manufacturing facilities (see related ePT stories, “Congress Focuses on FDA Inspections of Foreign Drug Facilities” and “SOCMA Offers Recommendations to Better Foreign Inspection Process.”) Recent high-profile cases such as with adulterated heparin (see the ePT story, “Active Ingredient in Baxter’s Recalled Heparin Made in China”) underscore the need for greater regulatory oversight of drug substances and drug products imported into the United States. But taken in a broader policy context, is allocating federal dollars to regulate foreign drug-manufacturers really good public policy for the United States?

One talking point emerging from the recent Presidential campaign has been a retreat from the North American Free Trade Agreement (NAFTA), with suggestions from both Sens. Barack Obama and Hillary Clinton on renegotiating the pact with better labor and environmental standards.

The debate on NAFTA and like free-trade policy largely center on discrete manufacturing and the economic loss associated with the attrition of manufacturing employment. But should we consider the same debate, and perhaps even more so given safety concerns, for pharmaceutical manufacturing?

Adherence to good manufacturing practices (GMPs) is a mindset or a culture that becomes embedded in the way a company operates. Is it a reasonable expectation that offshore producers can assimilate the GMP culture at a level that has been developed over many years by manufacturers in the US and Western Europe, and now even take GMP to a higher level with FDA’s goal to move to a risk- and science-based approach under quality by design?

Pharmaceutical manufacturing is one area for which the US needs a better marriage between regulatory and trade policy, not only for ensuring the safety of the supply chain but also in encouraging growth in higher-wage jobs in science and engineering.

What do you think? Leave a comment below.