The fallout continues from Johnson & Johnson's (NYSE: JNJ) big recall of over-the-counter children's meds. Another U.S. rep is demanding information, this time from the FDA, questioning whether the agency has enough authority to respond properly. And J&J CEO Bill Weldon (photo) stepped up with a "mea culpa" on the company's blog.
Rep. Rosa DeLauro, who chairs a House committee charged with FDA oversight, wrote the agency asking about its ability to respond to recalls and quality control mishaps. "The corporate oversight observed at this [J&J] facility appears to be symptomatic of reckless behavior that is clearly unacceptable," she writes in the letter. She also called J&J's "disregard" for good manufacturing practices "both unnerving and unethical."
Of particular concern to DeLauro: The agency's ability "to address potentially criminal behavior by a corporation." Would the FDA, for instance, refer evidence of possible criminal behavior to the Justice Department? Should Congress grant the FDA more power to recall drugs quickly and effectively? And so on.
Obviously, questions about the J&J plant in question--and about other recent recalls affecting products from McNeil Consumer Healthcare--have been all over the press lately, and DeLauro's inquiry isn't the only one coming from Congress. Weldon calls the recalls "a disappointment" and says that "one of our companies has let you down." His letter promises that the company will "make whatever changes are needed at McNeil to fully restore the quality of its manufacturing." We'll have to wait and see how that goes.
- see the release from DeLauro's office
- read Weldon's letter at JNJ BTW
- get more from Reuters