House Committee Surveying FDA’s Puerto Rico District 2000-2010 Oversight Activities

The House Committee on Oversight and Government Reform is requesting that FDA provide a wide variety of documents pertaining to the last decade of compliance oversight by its Puerto Rico field office.

The request for the in-depth information on the agency’s operations in Puerto Rico follows in the wake of the committee’s investigation into J&J’s recall and compliance problems at its McNeil Las Piedras facility and the news of the recent $750 million settlement of the government suit against GlaxoSmithKline (GSK) involving GMP non-compliance between 2001 and 2005 at its Cidra, PR plant (IPQ “In the News” November 1, 2010).

In a November 8 letter to FDA Commissioner Margaret Hamburg requesting the documents, Committee Chair Edolphus Towns (D-NY) and ranking member Darrell Issa (R-CA) referenced the committee’s September 30 hearing into J&J’s compliance/recall issues at its Puerto Rico facility (IPQ “In the News” October 4) and the late October news reports on the GSK settlement in questioning the PR district office’s oversight.

Of concern to the committee is the strength and speed of the PR district’s enforcement response when product quality is in question and the district’s ability to exercise its authority.

“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 letter maintains.  “We question whether the Puerto Rico district office is adequately staffed to fulfill the agency’s mission of securing the Nation’s pharmaceutical supply.”

[More on the Congressional inquiry and the requested documents is provided for subscribers here.  To subscribe to IPQ, click here.]