FDA Official: Johnson & Johnson's 'Secret' Recall No Secret

VIDEO: FDA Investigates Johnson and Johnson
Share
Copy

A U.S. Food and Drug Administration deputy commissioner testified before Congress today that the agency did not act quickly enough to stop Johnson & Johnson from carrying out a "phantom" recall last year.

Dr. Joshua Sharfstein divulged new details about when the FDA learned about Johnson & Johnson's plan to buy defective Motrin off store shelves instead of issuing a formal recall of the painkiller.

In documents obtained by ABC News Wednesday night, it appeared as if the FDA had known about Johnson & Johnson's plan to buy back faulty Motrin made in San Juan, Puerto Rico. E-mails revealed that the FDA's San Juan district director had forwarded field action reports from employees at McNeil, Johnson & Johnson's consumer health care unit, that mentioned the plan to buy back the product.

VIDEO: FDA Investigates Johnson and Johnson
Trouble at Johnson and Johnson?

Previous FDA statements suggested the agency had not known about the company purchasing the defective Motrin until July.

The San Juan e-mails found their way to FDA headquarters in Washington. In a Feb. 18 e-mail chain, Milind Ganjawala, who works in the FDA's Recalls and Shortages Branch of the Office of Compliance, was asked to review the accuracy of a paragraph about the Motrin recall that contained the following passage: "Instead of notifying the agency and issuing a recall of the product, your firm hired a third-party company to buy back the Motrin from the pharmacies and retail locations." Ganjawala wrote back saying, "The firm did notify the FDA via FAR's [field reports]. ... According to the document we have, the silent recall was ongoing on or around 6/12/09."

VIDEO: Johnson and Johnson Under Fire
Johnson & Johnson Under Fire

E-Mails Show FDA in Puerto Rico Knew of Plan

Although FDA officials said they did not know about a "phantom" or "silent" recall, in e-mails obtained by ABC News senior employees of the McNeil subsidiary were congratulating one another on receiving FDA support for their plan to buy back their product in lieu of a formal recall.

"Good news," one e-mail began. The FDA director in San Juan "is in agreement with continuing to pull product from the rest of the stores and NOT consider this a National Recall." Another e-mail stated that the FDA "is really bending the rules" by not automatically urging a recall, while another e-mail called the buyback program "a major win for us as it limits the press that will be seen."

VIDEO: Child Medication Recall
null

Johnson & Johnson declined ABC News' request for an interview. However, the company said in a statement that "McNeil kept the FDA informed of its actions and removed the product from the market in a compliant manner. However, given the concerns highlighted by the congressional committee with respect to Motrin, moving forward we would like to handle things differently."

The e-mails also revealed that senior executives at Johnson & Johnson's McNeil subsidiary coordinated the $400,000 Motrin purchase program from the start. The e-mails read: "Do not communicate to store personnel any information about this product. Simply visit the store, locate the product and if any is found, purchase all of the product."

One e-mail showed McNeil President Peter Luther authorizing the program, saying: "Let's make this happen ASAP."

VIDEO: Johnson and Johnson recalls more of its over-the-counter products.
Recall: More Tylenol Pulled From Shelves

There have been eight other Johnson & Johnson recalls in the past year -- 136 million bottles of children's medicines, including Children's Tylenol, Motrin Infant Drops, Children's Benadryl and Zyrtec.

Page
  • 1
  • |
  • 2
Join the Discussion
You are using an outdated version of Internet Explorer. Please click here to upgrade your browser in order to comment.
blog comments powered by Disqus
 
You Might Also Like...
See It, Share It
PHOTO: The fake baby a man was carrying as he and another woman tried to sneak into the mother and baby unit at Mercy Medical Center in Merced, Calif., hospital officials said.
Dignity Health Security/Mercy Medical Center Merced
PHOTO:
dpa, Jens Wolf/AP Photo
PHOTO: U.S. Customs and Border Protection officers at the George Bush Intercontinental Airport in Houston stopped a would be smuggler from bringing nearly 7 ounces of cocaine into the country in tamales, Aug. 22, 2014.
U.S. Customs and Border Protection
PHOTO: Giant panda Bao Bao celebrates her first birthday at the Smithsonians National Zoo, Aug. 23, 2014.
David Galen, Smithsonians National Zoo