Johnson & Johnson slow to act on problem drugs, FDA says
But promised improvements didn’t come quickly enough, and it was not until April 30 that the company — under FDA pressure — announced the largest recall of pediatric over-the-counter medicine in history.
Johnson & Johnson is under investigation by FDA’s criminal division to determine whether any of its missteps warrant prosecution, Joshua Sharfstein, the FDA’s principal deputy commissioner, told the House Oversight and Government Reform Committee.
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, and several million bottles of medications because of complaints of a musty odor that some consumers said made them sick.
Johnson & Johnson was required to notify the FDA of the consumer complaints within three days, Sharfstein said, but it waited a year to do so.
“What was troubling was there was a pattern of FDA finding out about things late,” he said.
Colleen Goggins, chairwoman of Johnson & Johnson’s consumer division, apologized “to the mothers and fathers and caregivers for the concern and inconvenience” caused by the April recall, which covered more than 40 compounds for infants and children — including Benadryl, Motrin and Zyrtec in addition to Tylenol.
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.
Some lawmakers dubbed it “a phantom recall.”
Goggins told the House Committee On Oversight and Government Reform that she did not know what instructions the buyers were given, but said, “I don’t believe there was any intent mislead or hide.”
She emphasized that there were no known illnesses or deaths linked to the products recalled in April.
But authorities disclosed that there had been hundreds of adverse events, including 37 deaths since Jan. 1, 2008 — including seven since April 30. However, the FDA has not established that any of the deaths or adverse events were caused by the medications, Sharfstein said.
Before the recall, an FDA inspection at the Fort Washington, Pa., plant that produced the pediatric medications found bacterial contamination of an ingredient, inadequate employee training, substandard equipment maintenance and a failure to investigate dozens of reports of foreign materials in medication.
After the recall, Johnson & Johnson closed the plant, which won’t reopen until the company finishes a review of the North American drug-making operations of McNeil Consumer Healthcare, the subsidiary that produced the recalled medications, Goggins said.
Johnson & Johnson will present a plan for improving its manufacturing processes to the FDA by July 15, she said.
Goggins framed the recalls as problems confined to McNeil.
But Sharfstein said Johnson & Johnson bore responsibility, noting that the February meeting was “extraordinary” because it marked the FDA’s attempt to go over the heads of McNeil executives to top decision-makers in the conglomerate.
“There are still many unanswered questions” about Johnson & Johnson’s openness in addressing its problems, said oversight committee Chairman Rep. Edolphus Towns (D-N.Y.). He promised further scrutiny of the company.
Towns and ranking GOP member Rep. Darrell Issa (R-Vista) agreed that the hearing highlighted the need for the FDA to have its own authority to recall medications, instead of having to rely on drug-makers to do so.