FDA Oversight in Puerto Rico Under Scrutiny

Yesterday, Congressional investigators announced that they are implementing an investigation into how the U.S. Food and Drug Administration’s (FDA) Puerto Rico office oversees <"http://www.yourlawyer.com/practice_areas/defective_drugs">pharmaceutical plants there, said Bloomberg Business Week.

Edolphus Towns (Democrat-New York), the House Oversight and Government Reform Committee Chairman and Darrell Issa (Republican-California)—Issa are slated to head the panel—asked if FDA staff could handle the regulatory responsibilities in Puerto Rico, which boasts one of the largest concentrations of drug makers worldwide, said Bloomberg News.

“It appears that FDA’s Puerto Rico district office may be having difficulty exercising oversight on the numerous pharmaceutical manufacturing facilities on the island,” the lawmakers wrote in a letter to FDA Commissioner Margaret Hamburg, quoted Bloomberg News. The letter also requested an update on the “phantom recall” of Motrin that was conducted by a Johnson & Johnson unit in Puerto Rico, said Bloomberg News. In September, executives at Johnson & Johnson and the FDA shared the blame for the recall that involved hired contractors purchasing defective painkillers from store shelves in secret, explained Bloomberg News.

The investigators have requested a list of current and prior employees in Puerto Rico, as well as all inspection and warning letters issued in the past 10 years, “to better understand whether FDA Puerto Rico is fulfilling its regulatory responsibility,” quoted Bloomberg News.

The Puerto Rican office has been faulted for lacking quality control; however, officials with the agency claim that the problems seen in Puerto Rico are no greater, proportionally, than those seen in offices on the United States mainland, said Bloomberg News. Advocates say that the agency is operating inefficiently both on the island and on the mainland.

Towns and Issa wrote that “additional questions” concerning operations in Puerto Rico came to light following an announcement by drug giant GlaxoSmithKline PLC late last month that it agreed to pay $750 million to settle allegations concerning flawed processes at its plant in Cidra, said Bloomberg News. Also, last month, the pharmaceutical company issued a statement saying it regretted opening the plant in Puerto Rico in such a way as to violate good manufacturing practices, wrote Bloomberg News.

Earlier this year we also wrote that a review of the FDA revealed that only a small percentage of drug trials conducted overseas are being reviewed by the agency, citing the Associated Press (AP). With more and more drug testing activities being conducted outside of the United States, this presents a potential problem, the AP added.

This entry was posted in Pharmaceuticals. Bookmark the permalink.

© 2005-2018 Parker Waichman LLP ®. All Rights Reserved.