The House Committee on Oversight and Government Reform opened an investigation in early May shortly after McNeil Consumer Healthcare, the unit of Johnson & Johnson that makes over-the-counter drugs, announced a voluntary recall of liquid pediatric Tylenol, Motrin, Benadryl, and Zyrtec. Congressional investigators are now accusing J&J oof trying to stymie thier investigation, and are threatening to turn up the heat by issuing subpoenas.
McNeil Consumer Healthcare, is already under scrutiny by the FDA for a pattern of violations in manufacturing and quality control practices that have led to a number of recent recalls. The agency said last month that it was considering criminal penalties or other actions against McNeil. The reason for the May 2010 recall is that the liquid pediatric medicines may have included metal particles, too much of the active drug ingredient, or inactive ingredients that were contaminated or did not otherwise meet sterility testing standards, according to the FDA. If true, this is all symptomatic of very poor quality control at McNeil’s Fort Washington, Pa plant where these drugs are manufactured or compounded.
McNeil got off on the wrong foot when it initially told the FDA that it had rejected the defective products before they reached stores. The Congressional committee held a hearing on May 27th which set off a chain of events that exposed McNeil’s duplicity.
The House committee is now examining a new recall of children’s medicines that were made for another company by the McNeil plant involved in the Tylenol recall.
The committee has also opened an investigation into an incident last year in which McNeil hired private contractors to purchase certain defective Motrin products from stores, an event which the committee chair described as a “phantom recall.” After F.D.A. officials inquired about the contractors’ activities, McNeil instituted an official recall.
“It was troubling to us,” Dr. Joshua M. Sharfstein, the agency’s principal deputy commissioner said during the Congressional hearing. “When F.D.A. found out about this, we insisted that an actual recall occur.” One purchase order regarding the "phantom recall" that was discovered by the investigators indicated that McNeil had hired a contractor in 2009 to visit 5,000 stores, or about 100 stores per state, for a fee of $487,500. A document from another contractor, titled “Motrin Purchase Project (June 12, 2009),” instructed employees buying Motrin to “simply ‘act’ like a regular customer” and make “no mention of this being a recall.” This evidence contradicted claims by J &J at the May 27 hearing that the recall in question was limited and transparent.
The investigators later found out that McNeil’s claims that its Fort Washington plant did not make products for other companies was false. It turns out that that plant made children’s cough and cold medicines for Blacksmith Brands which four days markets PediaCare children’s medicines. Blacksmith announced its own voluntary recall "as a precautionary step" because certain of its products had been made at the McNeil plant.
The amazing thing is that J&J is probably paying gobs of money to some consultant who is advising them to continue to cover this up. Hasn’t anyone learned from Nixon and Clinton about what happens when one does not come clean and get out ahead of scandals? J&J should hire Tiger’s media consultants.