There's a reason why so many pharma plants in Puerto Rico have drawn manufacturing warnings from the FDA, a new study suggests. Researchers found drugs made in offshore plants are more likely to have quality problems than meds made by the same companies in the U.S.--and that calls into question the industry's move to ship more production overseas.
The study looked specifically at pharma plants in Puerto Rico, comparing them with facilities operated by the same company on the U.S. mainland. The team looked at FDA inspection reports from 1994-2007. Researchers cast about for reasons for the quality differences. They discovered quality wasn't a function of distance from company HQ, education levels in the plant's region or the presence of other drug plants in the area.
What was? The cultural differences, including language, that interfere with local workers' training, the researchers concluded. And the quality differences could be more extreme in countries that are less developed--and less similar to the U.S.--than Puerto Rico, Ohio State business professor and study author John Gray said.
"Many people, including some pharmaceutical executives, think offshore plants can produce drugs at significantly less cost but with the same quality risk as plants in the U.S. But we found that may not always be the case," said Gray, who formerly worked as an operations manager at Procter & Gamble. "We believe the quality differences we found in Puerto Rican plants were driven by challenges in transferring knowledge from headquarters to the plant, due to cultural differences, primarily differences in language and values."
- read the release from Ohio State