House oversight committee probing possible second secret recall by J&J, other recall issues

House probing possible second secret recall by J&J

TRENTON, N.J. — Congress is investigating whether Johnson & Johnson carried out a second secret recall of faulty pain relievers last year, as a major probe of a dozen J&J recalls escalates.

In the first such recall, packets of possibly defective Motrin were quietly bought from stores across the U.S. in spring 2009.

E-mails just released by the House Committee on Oversight and Government Reform show a contractor hired for that job wrote to colleagues that his company was considering a “similar but potentially larger recall for July involving Children’s Tylenol” for J&J. It’s still unknown whether that happened.

“The facts we are uncovering in this investigation are extremely troubling,” the committee chairman, Rep. Edolphus “Ed” Towns, D-NY, said Friday. “The American people still deserve answers about Johnson and Johnson’s recall of more than 130 bottles of children’s medicine and the phantom methods they have used in other cases to avoid recalls.”

Document searches and interviews by panel investigators point to a former J&J employee who claimed the first “phantom recall” in spring 2009 was approved by federal regulators, a person close to the committee’s investigation told The Associated Press on Friday. However, that claim appears not to be true, said the source, who requested anonymity because the four-month-old investigation is continuing.

Meanwhile, Johnson & Johnson said Friday it still has not decided whether the head of consumer products, Colleen Goggins, will testify at a committee hearing Sept. 30. Hours after the hearing was announced Thursday, J&J said Goggins, 56, will retire in March. CEO William Weldon, who sent Goggins in his stead to the committee’s first hearing on May 27, will attend this one.

E-mails released by the committee late Thursday include one written June 30, 2009, by a contractor, WIS International, hired to quietly buy up small containers of Motrin that might have the wrong potency. In discussing the possibility of a similar Children’s Tylenol recall, the contractor wrote that his company “will look to explore next week the potential quantities in 400 geographically dispersed stores to ‘assess’ quantities on shelves” at grocery, drug, convenience and mass discount stores, the e-mail states.

WIS was working as a subcontractor to a second company, Inmar Inc., specializing in product recalls, according to the committee source.

The House committee investigators are still trying to determine whether that recall ever occurred, the source told the AP Friday.

Spokespeople at the two contracting companies did not respond to AP requests for comment Friday.

Since last September, J&J’s McNeil Consumer Health Care, the maker of adult and children’s Tylenol, Motrin, Benadryl and other nonprescription medicines, has had nine public recalls due to a variety of safety and effectiveness problems, including contamination with bacteria and with tiny metal shavings. One in April, involving more than 135 million bottles of infants’ and children’s Tylenol and other medicines, triggered the committee’s investigation. J&J also has recalled contact lenses and hip implants this summer.

Committee staff have learned that a man working at a J&J facility in Puerto Rico falsely told superiors last year that a female Food and Drug Administration staff member told him at a trade show that J&J could privately recall possibly defective packets of Motrin, said the source, who did not identify the man.

By then, the man’s claim, apparently accepted as true, had made it into an e-mail circulated among McNeil employees.

FDA does not have the power to order a product recall, but generally works with companies planning one.

“We have negotiated an agreement with FDA not to formally conduct a recall for Motrin” eight-tablet packages, reads a May 27, 2009, e-mail from McNeil executive Bob Miller to several colleagues. “It is now estimated that this will cost approx. $400K which is approximately 2x that which was originally quoted.”

A response from colleague Peter Luther the same evening reads, “I hope we’re not going to really double our cost to do this. Let’s make this happen ASAP.”

The source said the committee repeatedly has asked J&J lawyers to produce evidence that the FDA allowed the silent recall, but none was included in the 25,000 pages of documents the company has turned over. In addition, a July 2009 memo from an FDA investigator in Puerto Rico to a McNeil executive, Carolyn Parziale, states FDA’s “position is that your company should be doing a voluntary recall” of the Motrin.

Investigator Neisa Alonso wrote that public recalls are typical when drugs fail to dissolve, which was the case with Motrin that was removed. That can affect potency.

FDA spokeswoman Elaine Gansz Bobo said Friday the agency can’t comment because its investigation continues.

J&J would not discuss the latest disclosures by the committee, nor the positions of the executives listed in the e-mails. However, profiles on LinkedIn, a networking site for professionals, state that Parziale is director of quality assurance at McNeil Consumer & Specialty Pharmaceuticals, Luther is president of that unit and Miller is a quality assurance expert who had been the unit’s vice president of compliance.

During her testimony before the House committee on May 27, Goggins, the consumer business head, said she knew little about the unannounced recall and said J&J was not trying to hide anything and was fixing the manufacturing problems.

But officials at both WIS and Inmar, interviewed this summer by committee lawyers, told them — contrary to previous claims by J&J officials — the secret Motrin recall was directed entirely by J&J executives, the source said.

In addition, documents J&J turned over after a request by Chairman Towns detail specific instructions McNeil provided on how the contractors should conduct the recall. That included orders to buy up all available supply and not to discuss it with personnel in the stores.

Towns has introduced legislation that would give FDA the authority to order product recalls. The bill has not seen action yet.