J&J, Glaxo Actions in Puerto Rico Spark Probe of FDA

Nov. 8 (Bloomberg) -- Johnson & Johnson’s and GlaxoSmithKline Plc’s drug-safety missteps sparked a Congressional investigation of U.S. regulators overseeing manufacturing in Puerto Rico.

Representatives Darrell Issa and Edolphus Towns sent a letter today to Food and Drug Administration Commissioner Margaret Hamburg, asking for inspection records and warning letters from the past decade, “to better understand whether FDA Puerto Rico is fulfilling its regulatory responsibility.” Issa, a California Republican, and Towns, a New York Democrat, lead the House Committee on Oversight and Government Reform.

The lawmakers said they have questions on actions by FDA employees in Puerto Rico during J&J’s “phantom recall” of Motrin in 2008, when contractors tried to retrieve quantities of 88,000 packages of faulty drugs sent to stores without notifying the FDA. On Oct. 26, Glaxo agreed to pay $750 million to settle a government false-claims lawsuit over the sale of defective drugs made at a plant in Puerto Rico.

“It appears that FDA’s Puerto Rico district office may be having difficulty exercising oversight on the numerous pharmaceutical manufacturing facilities on the island,” Issa and Towns wrote. “We question whether the Puerto Rico district office is adequately staffed to fulfill the agency’s mission of securing the nation’s pharmaceutical supply.”

Drug-manufacturing facilities in Puerto Rico failed inspections 64 percent of the time in 446 visits from regulators from 1999 to 2010, according to data compiled by Bloomberg. The facilities have failed at more than a 70 percent rate since 2007, including a 76 percent rate in 29 inspections this year.

J&J, of New Brunswick, New Jersey, is the world’s largest maker of health-care products. London-based Glaxo is the U.K.’s biggest drugmaker.

Dick Thompson, a spokesman for the FDA, said the agency will respond to the lawmakers.

To contact the reporter on this story: Catherine Larkin in Washington at clarkin4@bloomberg.net.

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net.