Probe suggests J&J, FDA in tug of war over recall

When is a recall not a recall? Perhaps when it's called a "retrieval." In the Congressional investigation of recent J&J recalls, documents are emerging that show the company and FDA tussling over terminology. And to hear investigators tell it, the documents suggest that J&J's McNeil Consumer Healthcare unit did in fact direct the alleged "phantom recall" of suspect Motrin tablets.

Internal e-mails and other communications indicate that McNeil directed contractors to surreptitiously buy up stocks of the Motrin tablets, despite the company's contention that the contractors were instructed only to purchase a sampling of product for testing, the New York Times reports. "Just purchase all available product," one McNeil instruction stated, while another told the contractors, "Do not communicate to store personnel any information about this product."

A McNeil spokeswoman told the Times that "the objective was to remove the affected product from a unique distribution channel, mainly convenience stores and gas stations, with as little disruption and consumer confusion as possible." But it's that very objective that ended up raising the ire of FDA. The company told the agency it would "retrieve" the products from stores; the agency fired back, saying, "It seems that your company is doing a recall even though you are calling it a 'retrieval.'" 

"The agency's position is that your company should do a voluntary recall of the product," an FDA investigator in Puerto Rico--where the suspect tablets were made--told the company, "since it appears to be that you are already doing a recall of the product."

Meanwhile, other documents indicate that McNeil was working with FDA reps in Puerto Rico to avoid a public recall if possible, Portfolio reports. And emails obtained by Pharmalot include one message from a contractor to various J&J employees saying his employees would "buy all product as mystery shoppers" and suggesting some disingenuous responses to "curious retailers."

Of course, this is just a tiny sampling of the documents J&J has provided to the House Committee on Oversight and Government Reform. They certainly don't tell the whole story. We'll keep you posted as more details emerge.

- read the NYT story
- get more from the Wall Street Journal
- see the post from Portfolio
- check out the Pharmalot piece