FDA Refers Tylenol Issue to Crime Division

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FDA Refers Tylenol Issue to Crime Division

By Emily P. Walker, Washington Correspondent, MedPage Today
Published: May 27, 2010

WASHINGTON -- The FDA is considering criminal action against the Johnson & Johnson unit that makes Tylenol following the recent series of recalls and a history of manufacturing problems, a top FDA official told a congressional panel today.

The agency also told members of the House Oversight and Government Reform Committee that in 2008 the company's subsidiary McNeil Consumer Products hired contractors to secretly pull Motrin products that didn't dissolve properly off store shelves in Puerto Rico rather than announce a formal recall.

A spokeswoman for Johnson & Johnson denied that the company was ever trying to be secretive with its actions.

Joshua Sharfstein, MD, principal deputy commissioner of the FDA, told the panel that the agency is considering additional enforcement actions -- including seizure, injunction, or criminal charges -- against the company for a "pattern of noncompliance" with good manufacturing practices.

An agency official told the panel that the matter has been referred to the FDA's crime division.

In April, Johnson & Johnson recalled more than 136 million bottles of liquid infants' and children's products made by McNeil. That was the the third recall in a year, but the issues the FDA has had with McNeil go back further and involve problems with lab controls, equipment cleaning, failure to investigate reported problems, and long delays between the discovery of problems and their report.

Sharfstein said the company attempted to quietly remove Motrin products from shelves in 2008 by sending contractors into stores to buy up paper two-packs of adult Motrin, which were determined to have issues with solubility.

Committee chairman Edolphus Towns (D-N.Y.) displayed an e-mail that appeared to be from a McNeil employee instructing the contractors to pretend they were regular customers, not mention a recall and, if asked, to say their employers wanted the products as part of a distribution chain project.

"I just find it very, very disturbing," Towns said.

The FDA was alerted to the suspicious behavior by a state pharmacy board in Oregon, Sharfstein said.

Johnson & Johnson had previously told the FDA that the adult Motrin tablets didn't seem to be dissolving properly, but the agency was troubled to learn that the company paid workers to carry out a "phantom recall," he said.

After the FDA asked the company about the action, McNeil issued a recall of about 88,000 units of adult Motrin products in 2009.

When Colleen Goggins, worldwide chairman of Johnson & Johnson's consumer group and a member of the company's executive committee, denied any sneaky behavior or ulterior motives behind the company's removal of the product from shelves in Puerto Rico.

She said an FDA branch in Puerto Rico knew of solubility issues with the medication, and the agency knew that the company was sending contractors to remove the product.

"There was never any intent to mislead or hide anything," Goggins said, adding she couldn't tell the panel what, exactly, the contractors were instructed to do.

The solubility issue meant the drug would not work as quickly, but wasn't harmful, Goggins said.

The "phantom recall" was just another red flag for the FDA to keep a closer eye on McNeil's plants and products, Sharfstein said.

Sharfstein told the panel that the agency grew increasingly concerned with the quality of manufacturing processes at McNeil's various over-the-counter medication plants and began inspecting the facilities more frequently.

In February 2010, the FDA went over the heads of McNeil executives and straight to its parent company, and convened what Sharfstein called an "extraordinary" meeting with top officials from Johnson & Johnson. At the meeting, the FDA told the company executives that "immediate steps were needed to address issues of compliance and quality."

McNeil's most recent recall involved 136 million bottles of adult and children's medicines spurred by the discovery of particulates of acetaminophen, cellulose, nickel, and chromium in a number of liquid medications manufactured at McNeil's Fort Washington, Pa., facility. Some medications at the facility were also found to have had higher doses of the active ingredient than indicated on the label.

That plant was shut down in April.

"We will not reopen that plant until we meet our own, the FDA's, and the public's standards for safety," Goggins said.

No one appears to have been harmed from medication involved in the most recent recall, Sharfstein said.

One little girl died, but those autopsy results are still pending and might have been caused by the drugs themselves and not any contaminants in those products.

"Although the public health risk from these quality problems is low, these problems never should have occurred," Sharfstein said, adding that lack of attention to good manufacturing processes at the facility was unacceptable.

An earlier recall included 60 million bottles of Tylenol, Motrin. and other products following consumer complaints of "an unusual, moldy, musty, or mildew-like odor," that was eventually connected to a chemical used to treat wooden pallets on which the products were shipped.

In her testimony, Goggins apologized to the "mothers, fathers, and caregivers for the concern and inconvenience caused by the recall," and said the quality issues at the McNeil plants are "unacceptable to us."

Goggins said the company has changed six leadership positions in its drug division and plants and undertaken a broad assessment of all plants. The company will submit a master safety plan to the FDA in July.

During the hearing, members of Congress repeatedly brought up the fact that FDA does not have the authority to recall drugs.

"I want to talk about the elephant in the room," said Rep. Jackie Speier (D-Calif.). "I think the elephant in the room is you don't have recall authorities. If [McNeil] had chosen not to recall those products, you would have had to go to court," Speier said, referring to the most recent recall of 42 varieties of McNeil medicines.

Although it doesn't have the authority to demand recalls, the FDA can file a criminal suit that can result in seizures of products and court-ordered recalls.

A bill pending before Congress would give the FDA authority to recall tainted foods, but it wouldn't extend that authority to drugs.

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