Scrutiny of J&J’s ‘phantom recall’ grows as lawmaker seeks proof of agreement with FDA

Lawmaker asks J&J for proof of recall agreement

WASHINGTON — Scrutiny of drug and consumer product giant Johnson & Johnson ratcheted up Tuesday as a congressional chairman demanded the company provide proof of its claim that federal regulators cleared a plan to secretly buy up defective painkillers.

The letter from Rep. Edolphus “Ed” Towns, D-N.Y., comes a week ahead of a hearing to scrutinize J&J’s “phantom recall,” conducted last year, when the company paid an outside contractor to quietly purchase more than 88,000 packets of Motrin off store shelves.

A J&J executive testified in May that the FDA “was aware” of the action. And internal e-mails among J&J employees state that the company “negotiated an agreement with FDA not to formally conduct a recall.” The e-mails were released by the House Oversight and Government Reform Committee, which Towns chairs.

The FDA has stated that it did not know of J&J’s secret purchase plan until July 2009, when it demanded the company recall the product, which did not dissolve correctly.

Towns’ letter asks William Weldon, J&J’s chairman and chief executive officer, to provide a copy of the alleged agreement between his company and the FDA, or describe its terms if it wasn’t written down.

A J&J spokeswoman said Tuesday, “We’ve been cooperating with the committee and will respond accordingly.”

The effort by Towns to refocus scrutiny on J&J comes as his Republican counterpart increasingly questions FDA’s role in approving the phantom recall.

“We need to uncover the true extent of what the FDA knew and when they knew it and determine whether or not they acted appropriately and timely,” said Rep. Darrell Issa, R-Calif., in a statement Tuesday. Issa has said congressional investigators should interview FDA officials tasked with overseeing J&J’s Motrin product.

FDA Deputy Commissioner Joshua Sharfstein, an Obama appointee, is scheduled to appear at the committee’s hearing Sept. 30.

Congress’ investigation into J&J originally centered on a series of nine recalls of over-the-counter medications over the past year.

The recalls have involved problems ranging from liquid medicines that may contain tiny metal shavings and drugs that may not have the correct amount of active ingredient.

The New Brunswick, N.J.-based company is the world’s largest maker of health care products, selling everything from Band-Aids and baby shampoo to birth control and biotech drugs.

Last week J&J announced that Colleen Goggins, the head of the division responsible for most of the company’s recent recalls, would retire. Goggins testified on the recalls in place of Weldon at the committee’s last hearing on the issue.

(This version CORRECTS day of week in first paragraph to Tuesday)