FDA may seek criminal penalties against J & J for faulty recall of children's Tylenol, other medicines

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May 29 2010

The Wall Street Journal: "The Food and Drug Administration said it is weighing whether to seek criminal penalties against the Johnson & Johnson unit that made children's Tylenol and other over-the-counter kids' medicines recalled last month. Joshua Sharfstein, the FDA's principal deputy commissioner, told lawmakers at a hearing Thursday that J&J's McNeil Consumer Healthcare unit had a 'pattern of noncompliance' with good manufacturing practices. … Dr. Sharfstein said the agency was now working well with J&J and its McNeil unit, but he described a history of troubles getting the unit to fix violations" (Dooren and Rockoff, 5/28).

The Los Angeles Times reports that Sharfstein "characterized Johnson & Johnson's corporate culture as slow to respond and not always open about its actions. In addition to last month's recall, the company pulled 8 million bottles of children's medications off the market in September 2009 because of a quality-control issue. … In one previously undisclosed case, Johnson & Johnson learned in 2008 of a possible problem with its Motrin pain reliever but, instead of recalling it, hired a contractor who sent people out to buy up the product without revealing what they were doing. Buyers were instructed to "simply 'act' like a regular customer. … THERE MUST BE NO MENTION OF THIS BEING A RECALL," according to an instruction sheet obtained by House investigators" (Zajac, 5/28).

The Hill: "House Democrats on Thursday repeatedly called for federal regulators to be given the authority to recall drugs. Pending legislation would grant that power to the Food and Drug Administration for food, but not for drugs. Statements from lawmakers at a panel hearing Thursday made it clear many Democrats want to go further" (Pecquet, 5/27).

CongressDaily: "Some of those expanded powers [hinted at in the hearing] include mandatory quality systems and recall authority, access to certain company records, and the ability to issue civil money penalties. FDA representatives would not directly say the agency wanted expanded authority, instead saying the issue was being worked on by the administration" (McCarthy, 5/27).

This article was reprinted from khn.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.