FDA may be having difficulties in Puerto Rico, says US oversight cmttee
Congressmen Edolphus Towns and Darrell Issa made the suggestion in a letter to FDA Commissioner Margaret Hamburg yesterday, citing recent recalls by Johnson & Johnson (J&J) of Tylenol and Motrin made in Puerto Rico as evidence for the contention.
The politicians also flagged up last month’s $750m (€540m) settlement by UK drugmaker GlaxoSmithKline (GSK) of a 2002 case criticising practices at the its subsequently closed facility in Cidra as a further example the scale of the potential problem the office is having.
These events, they said, indicate that: “[The] FDA’s Puerto Rico district office may be having difficulty exercising oversight on the numerous pharmaceutical manufacturing facilities on the island,” before going on to question if the unit is adequately staffed.
Towns and Issa have asked for details of all inspections conducted in Puerto Rico since January 1, 2000, copies of all relevant field reports and Form 483s, a list of past and present FDA employees and a database of all facilities in the office’s jurisdiction.
They also want an update on the investigation of J&J’s so called “silent recall” with a specific focus on what FDA employees did at the time, setting a deadline of Wednesday next week for receipt of all the information.
The letter makes no mention of either Pfizer's recent recall of Lipitor packaged at Rexam's plant in Las Piedras or Bristol-Myers Squibb's (B-MS) receipt of an FDA warning for its facility in Manati.
The FDA told the New York Times it intends to respond to the Congressional inquiry after it receives the letter, but made no further comment.
The investigation comes at the end of busy few weeks of news for Puerto Rico’s drug industry, the highlight of which was the modification of tax laws to shift the burden on to multi-national firms that offshore drug manufacturing to the island.
It also follows hot on the heels of a US Government Accountability Office (GAO) report examining the FDA’s activities outside the continental US which, somewhat ironically given the Puerto Rico concerns, highlighted the benefits of overseas offices.
