Washington, DC - Congressman John D. Dingell (D-MI15) made the following remarks about the voluntary recall of certain over-the-counter (OTC) Children’s and Infants’ liquid products manufactured by McNeil Consumer Healthcare, a division of Johnson & Johnson.  The recall covers 43 over-the-counter medicines, including liquid versions of Tylenol, Motrin, Zyrtec and Benadryl.

“I am deeply concerned about the recent news related to these common products used by American children and infants.  The magnitude of this recall should not be overlooked and the Food and Drug Administration (FDA), in coordination with Johnson & Johnson, should continue to work diligently to identify the specific causes and remove all affected products from store shelves and medicine cabinets.

“I am disappointed that we find ourselves in the position of responding to another drug scare.  We are lucky to have no injuries or deaths linked to this episode. We are also lucky that the company involved has cooperated with FDA.  Unfortunately, luck will only take us so far.  We need not take any more chances and do what is necessary to prevent future episodes like this one from happening.  I have drafted drug safety legislation that would get to the root of the problem American children and infants now confront.  Something went wrong during the manufacture of these products and unfortunately it was not caught until FDA showed up.  H.R. 759 would require manufacturers to proactively develop a quality risk management plan that identifies and mitigates risk throughout their supply chain.  Companies should take full responsibility and control over the quality of their drugs.  We must shift the paradigm and place a greater responsibility on manufacturers to identify problems before they occur and put appropriate steps in place to prevent them from ever happening.

“I look forward to the swift resolution of this incident and to the swift passage of drug safety legislation that will prevent incidents like this from happening in the future.”

Rep. Dingell is the author of H.R. 759, the “Food and Drug Administration Globalization Act of 2009”.  H.R. 759 would grant FDA the authority and resources needed to regulate an increasingly global and complex drug, food, device, and cosmetic supply.  The food provisions of H.R. 759 served as the basis for H.R. 2749, the “Food Safety Enhancement Act of 2009”.  H.R. 2749 passed the U.S. House of Representatives in July 2009.  Similar legislation awaits action in the U.S. Senate.