Congress Expands Probe Into J&J Recall Scandal
4 CommentsBy Ed Silverman // June 2nd, 2010 // 4:45 pm
Hot on the heels of a hearing into Johnson & Johnson’s recall of dozens of over-the-counter medicines, including many popular brands used by children, the House Committee on Oversight & Government Reform is now eyeing a recall last week by Blacksmith Brands, which sells four different versions of PediaCare that were made by J&J’s troubled McNeil Consumer Healthcare unit.
Committee chair Ed Towns, a New York Democrat, wants more info on what Blacksmith Brands ceo Peter Mann last week called a “precautionary” move (see here). The Blacksmith PediaCare was made at the same Fort Washington, Pa., plant where the FDA found McNeil had extensive quality control problems (see the FDA report). The plant was responsible for making tens of millions of pediatric meds - PediaCare, Motrin and Children’s Tylenol, among others - prior to the May 2010 recall, and Towns wants to know about any adverse events reported or contamination that may have been found (see this).
The hearing, you may recall, did not go particularly well for J&J. After learning of potency problems with Motrin in 2008, McNeil didn’t issue a recall, but hired an outside contractor to buy Motrin from stores to determine whether a recall was needed. The contractor’s employees were then instructed not to discuss a possible recall (look at this note by the contractor).
Elaine
Confused about the criteria and reporting of AERs to validate risk. A parent would likely be using one or more of these meds as a “remedy” of some sort for an existing medical problem.
With the exception of extreme and acute reaction(s), how would a parent know or suspect an adverse event specific to the “remedy,” let alone think to report it? To me it seems unreliable.
Some of these meds for example are intended for children with known allergies, or eczema. Tainted medication could likely exacerbate symptoms of these original medical conditions without anything ever attributed to the medication itself.
M. Black
Given all, it would be a MAJOR sign of NEGLECT on the part of the FDA, and likely ORA as well to really AUDIT (not hang out for a day or two eating donugh
donuts and drinking coffee FOR ALL of McNeil’s manufacturing contract partners. When you go in and come out with nothing, I will at that time lose the very last thread of confidence that these federally funded entities are COMPLETELY USELESS.
Completely…
~ M. Black
ex-FDAer
I disagree that FDA is completely useless. In spite of everything there were several people I know who made a difference in spite of the odds and and even sacrificed their livelihoods to do so.
ashlene
The FDA has issued a statement on theie website regarding safety of PPIs, however, when you call the P&G help line, the reps would say “it is all lies”.
So, does it mean FDA is lying??