PIA balks at ‘subjective’ pharma quality study
The Puerto Rico Pharmaceutical Industry Association raised three specific objections to the recently released study evaluating quality results in drug manufacturing plants outside the U.S. mainland, saying, among other things, the findings were “highly questionable.”
First, the organization known as PIA, which represents 12 companies with more than 30 manufacturing operations in Puerto Rico, disagreed on the study’s claim related to alleged knowledge transfer problems.
John Gray, lead author of the study and assistant professor of operations at Ohio State University’s Fisher College of Business, released the findings of a study concluding that drugs produced in U.S.-owned and operated pharmaceutical manufacturing plants in Puerto Rico are more likely to have quality problems than those produced by the same firm in a matched plant on the mainland.
He pegged the problem to difficulties in transferring world-class quality control to an offshore plant, even under the best of conditions.
“Technology transfer knowledge generated over more than 40 years of local experience, and evidenced by the success and confidence in Puerto Rico to transfer products of the highest technological complexity — some of which are also important products for their companies, the sales volume they represent, known as blockbusters — show the exact opposite of the conclusions that this study seeks to establish,” said PIA Chairman Jean-Christophe May, in a statement issued Monday.
“Companies that manufacture products in the island and its employees operate under strict quality principles established by their parent companies and following federal regulations, like those prevailing in other markets around the world served by the industry,” said May, who is general manager of GlaxoSmithKline.
Puerto Rico’s pharmaceutical industry generates 20,000 direct jobs and 65,000 indirect jobs, contributing close to 70 percent of the corporate taxes generated on the island, PIA said.
Secondly, PIA disagreed with the study’s conclusion that language and values and costs as elements that can affect the quality of products manufactured in Puerto Rico.
“This is subjective and speculative,” PIA’s May said.
“The staff working in our industry is totally committed to quality, operates to the highest standards of ethics and, moreover, is highly skilled and educated,” May said. “In addition, these professionals enhance their knowledge continuously through various training programs and continuing education provided or promoted by the companies.”
Lastly, May said the study denotes “highly subjective elements as part of its conclusions to which PIA objects.”
“A report in the U.S. media quoted Mr. Gray saying that investigators could not rule out the possibility that there is something peculiar about Puerto Rico to explain the results. This explanation does not correspond to any data contained in the study,” May said.
The study findings accounted for many of the alternative explanations about why offshore plants may have lower quality than those on the U.S. mainland. The Puerto Rico plants in this study were compared to plants on the U.S. mainland owned by the same companies, and manufacturing the same or similar drugs, so the conditions were very similar.
The results appear in the November 2011 issue of the Journal of Operations Management.
May said PIA has the study, which it will continue analyzing to “determine actions to take and ensure there is no doubt about the high levels of quality in local pharmaceutical operations.”
The Puerto Rico Manufacturers Association also expressed its disapproval of the study last week.