J&J Official Believed FDA Would Negotiate on Recall

A senior quality assurance official at a Johnson & Johnson division last year told another employee that the Food and Drug Administration may be willing to negotiate with the company to avoid a recall of defective Motrin.

An email from Paul-Michel Di Paolo, then senior director of quality assurance for J&J's McNeil drug division, shows that company officials were concerned about having to recall the product and were looking at other options. And, according to two accounts from company officials, local FDA employees in Puerto Rico, where McNeil has a manufacturing plant, were sympathetic.

The correspondence, reviewed by Portfolio.com, is a piece of thousands of documents turned over to a House committee investigating J&J's recalls. Congressional investigators charge that J&J last June sent contractors into stores to buy up supplies of defective Motrin rather than recall the product, which is the standard practice required by FDA. The company says it was simply conducting an audit and was trying to determine if a recall of two lots of Motrin was necessary. FDA officials were kept informed about the process, J&J says.

"FDA only said 'let's see the data first,' leading me to believe they may be willing to negotiate," Di Paolo says in his email dated March 24, 2009. "If the data shows a lot of the 2 lots on shelves then a national recall will be expected by FDA."

The email also says that officials at McNeil, the over the counter drug division of J&J, had discussions with the local FDA director in Puerto Rico. And according to Di Paolo's account, the local FDA official understood the company's desire to avoid an official recall of the product, which wasn't dissolving correctly.

"The District Director in (Puerto Rico) is willing to defend our stance if the data warrants. If the data is not favorable, her superiors in DC will be all over this and she won't have a choice but to recall," Di Paolo says in his email.

An email from another McNeil employee, Eddie Carrillo, also suggests that some contact was made with a Puerto Rican FDA official about the Motrin problem.

"All my conversations with the FDA Director here in PR (Puerto Rico) have been off the record, since I can not quote her. This happens due to my good relationship with her, that's why we are doing something very different." The FDA official is not named.

A source close to the investigation says the emails show a pattern in which the company was trying to avoid going through the proper channels to stage a recall. The much bigger issue, however, is how McNeil viewed safety and quality control issues in general. The Motrin issue is far-less severe than the recall of millions of packages of infant and children's medicines that got the House committee interested in J&J's practices in the first place.

Of course, some of these cryptic references like "something very different" need to be explained. The investigation continues. These emails are being submitted to the congressional committee from J&J and two contractors, Inmar of North Carolina and WIS International, a San Diego inventory management specialist.

The controversy over the Motrin audit started with a WIS memo that instructed field staff to buy up all packages of the product off store shelves. The memo was introduced at a hearing of the House Committee on Oversight and Government Reform last month and became known as the "phantom recall," a term repeated by committee chair Ed Towns, a New York Democrat.

J&J says there was no phantom recall. The company disagrees with the committee investigators' interpretations of certain emails.

“Given that there was no safety risk, 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,” the company says in a statement.

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Brett Chase covers health care for Portfolio.com and writes the blog Heavy Doses.