FDA official says agency took too long to halt J&J’s phantom recall of defective medicine

FDA exec: agency too slow to order J&J recall

WASHINGTON — 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 told members of Congress.

FDA deputy commissioner Dr. Joshua Sharfstein on Thursday disclosed new details about when the agency learned of the so-called phantom recall. The recall is at the center of the investigation by the House Committee on Oversight and Government Reform.

Sharfstein and J&J executives testified 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 said that J&J informed the FDA of its plan to repurchase the defective Motrin — which did not dissolve correctly — 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.”

However, Sharfstein stressed that the FDA did not know J&J had instructed contractors to pose as regular customers while buying the product, and not alert store employees to their activity.

“Based on the documents I reviewed, I don’t see any indication that the FDA was aware of the surreptitious, lying nature of the recall,” he said.

Sharfstein used his testimony to point out the limits of FDA’s authority, which do not allow the agency to order recalls. Recalls are initiated by manufacturers, who alert the FDA to their plans. Companies are advised to work with the agency, although this isn’t a legal requirement.

Oversight and Government Reform Chairman Edolphus Towns has introduced a bill that would give the agency the power to order recalls.

“Even if the FDA had been notified about the Motrin problem, the agency did not have the legal authority to order a recall,” Towns said. “This needs to be rectified.”

Earlier Thursday, 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.

“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.