PRMA takes exception to pharma quality study
The Puerto Rico Manufacturers Association rejected the conclusions of a study released this week saying language and cultural barriers among the employees in companies located in Puerto Rico and their stateside counterparts may be risk factors causing quality problems in local plants.
The PRMA “believes this study is based on the wrong premise and the methodology used is not reliable proof that local plants are more likely than U.S. plants to produce drugs with quality problems,” said PRMA Executive Vice President William Riefkohl.
“The report also reflects that ‘differences in quality standards’ found do not affect final product quality. If they do not affect product quality, what use does the publication of that study have, other than create a negative image of our industry and our workers?” he questioned.
As News is my Business first reported Wednesday, 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.
“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,” he said.
However, the PRMA differed.
“Puerto Rico’s pharmaceutical industry has a long and successful history and trajectory,” Riefkohl said. “Through more than 40 years, many multinational companies have decided to establish operations in the island making us the ‘world capital of the pharmaceutical industry’.”
Pharmaceutical operations in Puerto Rico have a long history of producing high quality medicines that are supplied globally. However, in recent years, the U.S. Food and Drug Administration has uncovered a string of quality issues at several local plants, including Bristol Myers-Squibb and Johnson & Johnson McNeil in Las Piedras, which have resulted in significant product recalls.
To this, the PRMA said it is “unacceptable to attribute quality events to challenges in the transfer of knowledge or language barriers in Puerto Rico. We disagree with the conclusions reached by the study and we reaffirm the high quality of Puerto Rico operations and the safety of products manufactured in the island.”