Hearing learns about ‘phantom recall’ efforts by McNeil

Nearly two years ago, officials at McNeil Consumer Healthcare realized they had a problem. Tens of thousands of packages of Motrin, in eight-tablet vials, had been found to be defective because they didn't dissolve properly. The question was what to do.

Their decision - dubbed the "phantom recall" by congressional investigators - was a key focus of a hearing Thursday of the House Committee on Oversight and Government Reform, which is examining problems at McNeil and its oversight by the Food and Drug Administration.

McNeil, a Johnson & Johnson subsidiary based in Fort Washington, has been stung in the last year by a series of high-profile recalls, culminating in the massive pullback April 30 of more than 140 million bottles of children's medicines.

McNeil directed consumers and stores to empty their shelves of all unexpired bottles of about 40 versions of liquid Tylenol, Motrin, Benadryl, and Zyrtec - the largest product recall in FDA history. Even before the recall, it closed its Fort Washington plant, where the children's products were made, and has said the facility would not reopen until next year.

But the relatively tiny recall of the eight-pill vials of Motrin, produced at a McNeil facility in San Juan, Puerto Rico, has continued to draw outsize attention from investigators. And it figured prominently as the committee questioned J&J chief executive officer William C. Weldon and Colleen A. Goggins, worldwide chair of J&J's Consumer Group.

Since May, committee members and staff have sifted through about 30,000 documents and e-mails provided by McNeil, J&J, and the FDA. Along the way, they pieced together details of the Motrin problem and McNeil's and the FDA's responses. A pill's failure to dissolve properly could render it ineffective.

Documents obtained by The Inquirer show that McNeil first told the FDA that it planned to hire a contractor to survey the marketplace to see if any of the travel-size vials were still for sale at convenience stores, gas stations, and other retailers. But the project then morphed into a retrieval effort: The contractor's staffers began to quietly buy the vials of Motrin.

One spring 2009 e-mail called it a "soft market withdrawal." Another likened the process to using "mystery shoppers," and then suggested responses for the fake shoppers to offer if challenged, such as, "We are looking at packaging changes/conditions of the product and will be purchasing some samples," or, "We are conducting random quality and/or packaging checks."

Only in August 2009, under pressure from FDA officials, did McNeil finally relabel the retrieval effort as a recall.

The documents make clear that McNeil's goal was twofold: To save both the expense of a formal recall, which would also have targeted Motrin that had already been sold, and to spare the company negative attention.

Because a federal grand jury is investigating problems at McNeil, the Justice Department advised the FDA not to make a key staff member from its San Juan office available to the committee, according to FDA Principal Deputy Commissioner Joshua M. Sharfstein.

Even so, San Juan district director Maridalia Torres figured prominently Thursday. Citing e-mails that described her cooperation with the Motrin retrieval, lawmakers from both parties criticized what they called evidence of an overly cozy relationship between McNeil and the FDA.

But Sharfstein, who said he had reviewed documents provided to the committee by McNeil, told the committee that buyback efforts were sometimes part of ordinary recalls and might not raise a red flag. He said FDA officials had become aware of the deception only after the contractor's efforts were well under way.

They didn't know about "the 'phantom' part of the phantom recall - that people were out there acting like regular customers and not telling the truth," he said.

Lawmakers on both sides of the aisle portrayed the Motrin recall as emblematic of problems in drug manufacturing and FDA oversight, but differed pointedly on how.

"The evidence indicates Johnson & Johnson did everything it could to avoid a formal recall," Chairman Edolphus "Ed" Towns, a Brooklyn Democrat, said in a closing statement. "J&J tried to pull a fast one on the American public, but they got caught."

Towns said he planned to push for legislation giving the FDA authority to order recalls, which Sharfstein said would avert circumstances such as those behind the phantom recall.

But California Rep. Darrell Issa, the committee's ranking Republican, said that while he was "very disappointed in Johnson & Johnson," the events uncovered by the inquiry were also evidence of governmental shortcomings.

"You had the ability to shut down the factory," Issa told Sharfstein. "No amount of authority makes up for the failure to do your job."