Lawmakers Question the Activities of FDA's Puerto Rico Office

The US Food and Drug Administration’s Puerto Rico district office “may be having difficulty exercising oversight on the numerous pharmaceutical manufacturing facilities on the island,” according to Rep. Edolphus Towns (D-NY), chair of the US House of Representatives Committee on Oversight and Government Reform. Towns made this remark in a Nov. 8, 2010, letter, also signed by Rep. Darrell Issa (R-CA), to Margaret Hamburg, the agency’s commissioner.

Towns’s letter mentions the Committee’s follow-up hearing on the recall of infant, children, and adult over-the-counter products conducted by McNeil Consumer Healthcare, a subsidiary of Johnson and Johnson (New Brunswick, NJ). During the hearing, committee members of both major parties raised “still unanswered” questions about the involvement of employees at FDA’s district office in Puerto Rico, said Towns.

Other recent developments such as the US Department of Justice’s $750-million settlement with GlaxoSmithKline (GSK, London) have added to lawmakers’ concerns about the activities of FDA’s Puerto Rico office. Towns’s letter cites a New York Times article stating that GSK sold 20 drugs with “questionable safety” made at a large Puerto Rican plant “that for years was rife with contamination.” The article said that FDA’s inspectors in Puerto Rico observed some problems at the plant, but missed most of them. The story has prompted the Committee to question whether FDA’s Puerto Rico office is adequately staffed to ensure drug safety.

Towns asked Hamburg to provide the following information about the Puerto Rico district office by Nov. 17, 2010:

• A list of all inspections it conducted since January 1, 2000

• Copies of all Form 483s and Warning Letters it issued since January 1, 2000

• A list of all current and former employees, their job titles, and their duties

• A list of manufacturing facilities that the office oversees

• An explanation of the extent of the office’s authority to issue Warning Letters, increase inspections, and levy penalties for violations

• A chart illustrating which FDA office oversees the Puerto Rico district office.

In addition to Johnson and Johnson and GSK, other pharmaceutical manufacturers recently have experienced problems relating to operations in Puerto Rico. This month, Pfizer (New York) recalled Lipitor tablets packaged at Rexam’s plant in Las Piedras. On Aug. 30, 2010, FDA sent Bristol-Myers Squibb (New York) a Warning Letter for failing to establish or follow rules to prevent contamination at its facility in Manati.

Letter:http://graphics8.nytimes.com/packages/pdf/business/20101108-DEI-Towns-Letter-to-FDA.pdf

Pfizer:http://pharmtech.findpharma.com/pharmtech/Manufacturing/Pfizer-Recalls-Additional-Lots-of-Lipitor/ArticleStandard/Article/detail/693629

Bristol-Myers Squibb:

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm225277.htm