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Johnson & Johnson Not Cooperating in Probe: Feds

Natasha Singer|The New York Times
Friday, 11 Jun 2010 | 9:33 AM ET

A Congressional investigation into a recent recall of children’s Tylenol and other pediatric medicines has been stymied by the manufacturer, Johnson & Johnson, investigators say, raising the prospect that new measures — like issuing of subpoenas to compel cooperation — could be invoked.

Tim Graham | The Image Bank | Getty Images

The unit of Johnson & Johnson that makes the over-the-counter drugs, McNeil Consumer Healthcare, is already under scrutiny by the Food and Drug Administration 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.

Now Representative Edolphus Towns, a New York Democrat who is the chairman of the House Committee on Oversight and Government Reform, said Johnson & Johnson had used delaying tactics in its dealings with the committee and in some instances had provided misinformation — accusations the company denies.

Such conduct has cast Johnson & Johnson in an unusually negative light, Mr. Towns said, and might compel the committee to take more aggressive action as it looks into drug quality and safety issues raised by the recall. Other large corporations investigated recently by the committee, including Bank of America and the insurance giant AIG , were more forthcoming, Mr. Towns said.

“But we are not getting the kind of information and cooperation from Johnson that I would like,” Mr. Towns said in a telephone interview.

A spokeswoman for McNeil offered a starkly different view of the company’s dealings with the committee. The spokeswoman, Bonnie Jacobs, said Thursday that the company had provided the committee with about 20,000 pages of documents, made its executives available for interviews and answered queries in a timely manner.

“We have been very cooperative with the committee,” Ms. Jacobs said.

Mr. Towns, however, said he was particularly troubled by apparent discrepancies in Johnson & Johnson’s accounts of its activities. The company, he said, told members of his staff that the recall involved six million bottles of children’s medicineseven as it informed the F.D.A. that the recall involved more than 136 million bottles.

“It means that we didn’t get a straight story from Johnson & Johnson,” Mr. Towns said. “We need to know where the spin is and where the truth begins.”

But Ms. Jacobs said there was a simple explanation: the numbers represented answers to two different questions from government officials. There were about six million bottles of the products in stores at the time of the recall, she said, and an estimated 136 million bottles in the hands of consumers.

The House committee opened its investigation in early May shortly after McNeil announced a voluntary recall of liquid pediatric Tylenol, Motrin, Benadryl and Zyrtec. The products, made at a company plant in Fort Washington, Pa., may have included metal particles, or too much of the active drug ingredient, or inactive ingredients that did not meet testing standards, the F.D.A. said.

McNeil said that it had rejected defective products before they reached stores and had not received reports of health problems caused by issues related to the recall. But consumers should stop using the products, the company said, even though the possibility of serious medical harm was remote.

On May 27, the committee held a public hearing, with testimony from an F.D.A. official and an executive from Johnson & Johnson, intended to shed light on the circumstances surrounding the large recall.

But, after the hearing raised new questions for legislators, the committee widened its investigation.

Mr. Towns said that the House committee was 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 Mr. Towns has 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.”

Ms. Jacobs of McNeil said that the company had contacted the F.D.A. after it discovered that two lots of Motrin did not dissolve properly. The company, she said, informed the agency that it planned to remove the products from stores and regularly gave the agency progress reports.

The escalating Congressional investigation, along with Mr. Towns’s complaints about stalling and discrepancies from Johnson & Johnson, has the potential to fuel the F.D.A.’s own inquiry. An agency official said during the hearing that the F.D.A. had referred the McNeil case to its office of criminal investigation, the agency’s law enforcement arm, which works with the Justice Department to prosecute companies accused of violating the laws governing drug manufacturing and marketing.

On Thursday, an F.D.A. spokeswoman said that the agency did not comment once it had referred a case for criminal investigation.

In a statement in late May on a company blog, McNeil said that it was undertaking comprehensive improvements in manufacturing and quality control systems.

But Mr. Towns said he found some recent actions by company managers troubling.

In particular, he faulted a company executive for implying during her sworn testimony that the “phantom recall” incident — in which contractors bought defective Motrin products off store shelves — was a limited and transparent transaction. Documents later provided by the company, he said, suggested more covert and larger-scale activity.

One purchase order among the evidence 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.”

Mr. Towns said he was “troubled by the information that was given to us at the hearing versus what we are actually seeing now in the documents.”

But Ms. Jacobs of McNeil said that the documents fully supported the executive’s testimony. The kind of Motrin was a small-volume product for McNeil, she said, and remained on sale mainly at convenience stores and gas stations. The “Motrin Purchase Project” document was created without McNeil’s knowledge by a subcontractor, she said.

But Mr. Towns cited further issues. During an interview in late May, Peter Luther, the president of McNeil, told House investigators that the Fort Washington plant involved in the Tylenol recall did not make products for other companies, Mr. Towns said.

Four days later, Blacksmith Brands, which markets PediaCare children’s medicines, announced its own voluntary recall “as a precautionary step” — because certain of its cough and cold products had been made at the same McNeil plant.

Ms. Jacobs said that McNeil had sold the PediaCare brand to Blacksmith last fall. The McNeil plant, she said, was making the PediaCare products on a temporary basis and had not fully transferred manufacturing to Blacksmith.

But Representative Eleanor Holmes Norton, a Democrat from Washington, who sits on the House oversight committee, said the company’s conduct seemed to her to demonstrate a continuing lack of transparency.

“The only way for Johnson & Johnson to reclaim any measure of credibility,” Ms. Norton said, “is to let it all out now.”

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