J&J chief, FDA give warring testimony on recalls

In remarks prepared for his appearance before a congressional committee today, Johnson & Johnson CEO Bill Weldon (photo) says three key things: One, its "phantom recall" of faulty Motrin tablets was a mistake. Two, the company let people down, and he's determined to fix that, in part with a $100 million investment in new equipment and facilities. Three, J&J is already making progress on getting its children's drugs back to market, planning to ship 1 million bottles of an as-yet-unidentified medication next week.

Make that four: Weldon also says FDA did, in fact, know about the phantom Motrin recall."McNeil informed FDA officials about McNeil's plans for an in-store assessment and then a retrieval of any of the 8-caplet Motrin vials that remained available for sale," Weldon says. Nonetheless, he says, the "product retrieval" was "not a model for how I would like to see Johnson & Johnson companies approach problems. McNeil should have handled things differently."

J&J has been under the microscope for months now as concerns about its quality control mounted along with the list of its recalled products. Weldon has made select public statements since then, usually mea culpas combined with pledges to fix the manufacturing problems that got J&J into this mess. The FDA has recently come under scrutiny for its handling of the J&J recalls, and until now has defended itself against charges that it knew the company was tap-dancing around with potentially faulty drugs.

FDA is sticking to that line, saying that McNeil may have kept the agency informed--but only partially. The company "did not fully disclose the likely scale of the action or the way that the company was intending to proceed," Deputy Commissioner Joshua Sharfstein will say at today's hearing. What's more, if FDA had the recall power some lawmakers want to give it, the "phantom recall" would never have happened, Sharfstein says. Stay tuned for more as the day goes on.

- see the Wall Street Journal story
- see the WSJ's live blog of the hearing
- read the news from Bloomberg
- get the New York Times coverage
- check out the Philadelphia Inquirer article

Virtual Clinical Trials Summit

Virtual Clinical Trials Summit: The Premier Educational Event Focused on Decentralized Clinical Trials

In this virtual environment, we will look at current and future trends for ongoing virtual trials, diving into the many ways companies can improve patient engagement and trial behavior to enhance retention with a focus on emerging technology and harmonized data access across the clinical trial system.