The safety of children's over-the-counter (OTC) pharmaceutical products is of
paramount importance to the American people. During the Committee's follow-up
hearing on the recall of infant, children, and adult OTC products by McNeil Consumer
Healthcare, LLC (McNeil), a number of bipartisan questions were raised regarding the
involvement of the U.S. Food and Drug Administration (FDA) district office in Puerto
Rico. Through documents produced to the Committee, there are still unanswered
questions regarding the silent recall and the actions of FDA Puerto Rico's employees.
Congressman Towns went right after the FDA: "It appears that FDA's Puerto Rico district office may be having difficulty exercising oversight on the numerous pharmaceutical manufacturing facilities on the
island." That, in my view is the understatement of the century, not just for P.R. but for the FDA's oversight of all facilities.
He goes on to write: GlaxoSmithKline sold 20 drugs with questionable safety that were made at a huge plant
in PUelio Rico that for years was rife with contamination.'
The FDA was given until 11/17/2010 to produced numerous documents. In my humble opinion, heads must roll. The public is grossly unprotected by an ineffective, toothless FDA that is underfunded and hopelessly understaffed. I've come to the conclusion that in my lifetime, nothing will change.