FDA Exec. Says Agency Too Slow to Order J&J Recall

By: AP
By: AP

WASHINGTON (AP) -- The Food and Drug Administration should have acted sooner to halt a secret recall by Johnson & Johnson in which the company last year bought up defective packets of Motrin from stores across the country, a top official from the agency says.

FDA deputy commissioner Dr. Joshua Sharfstein plans on Thursday to disclose new details about when the agency learned of the so-called phantom recall, according to prepared testimony obtained by The Associated Press. The phantom recall is at the center of the investigation by the House Committee on Oversight and Government Reform.

Sharfstein and J&J executives are testifying at the committee's second hearing into broader quality problems that have forced J&J to recall tens of millions of bottles of popular painkillers and other nonprescription medications in the past year.

Sharfstein states that J&J informed the FDA of its undercover purchasing plan in April 2009.

"From this point, it took until July for the FDA to tell the company that a recall should be conducted," states Sharfstein's testimony. "In my opinion that message should have been given sooner."

Previous statements by FDA spokespersons have said the agency was unaware of the plan until July, when it demanded the company conduct a formal recall.

In his testimony to the committee, William Weldon, J&J's chief executive, said his company "let the public down" with a string of recalls stretching back over a year, according prepared testimony. The maker of trusted brands like Tylenol and Benadryl, J&J has announced nine recalls of drugs for children and adults since last September. Problems ranged from too much of active ingredient to tiny shards of metal. This summer, J&J also recalled some hip implants and contact lenses.

Weldon also suggested the company made a serious mistake when it hired a third-party contractor to buy up bottles of defective lots of Motrin, rather than issuing a formal recall. The pills in question did not dissolve correctly.

"This episode was not a model for how I would like to see Johnson & Johnson companies approach problems with defective products," Weldon said.

Weldon missed the committee's hearing in May because of back surgery.

J&J executives say the FDA was aware of the purchasing program, but FDA officials deny that claim.

Lawmakers also will question J&J executive Colleen Goggins, who oversaw the consumer division of the company's McNeil Healthcare unit during the recalls.

At the May hearing, Goggins told lawmakers she had no knowledge of instructions to contractors involved in the phantom recall to not tell store employees what they were doing. In her testimony Thursday, Goggins acknowledged that the company wrote those instructions.

"Based on what I have learned since May, I believe that McNeil should have handled things differently," Goggins said.

Goggins will retire in March, Johnson & Johnson announced this month.


WILX.com is happy to provide a forum for commenting and discussion. Please respect and abide by the house rules:

Keep it clean, keep it civil, keep it truthful, stay on topic, be responsible, share your knowledge, and please suggest removal of comments that violate these standards.

powered by Disqus
WILX 500 American Road Lansing, MI 48911 517-393-0110
Gray Television, Inc. - Copyright © 2002-2014 - Designed by Gray Digital Media - Powered by Clickability 104082883 - wilx.com/a?a=104082883