Hot on the heels of the weekend recall of various Johnson & Johnson over-the-counter meds for infants and children, the House Committee On Oversight and Government Reform is launching a probe, partly due to conflicting accounts given by the FDA and the drugmaker over the circumstances surrounding the recall, including what prompted the recall and the seriousness of the recall."
The recall affects about 70 percent of the market for over-the-counter pediatric liquid meds, including Tylenol, Motrin, Benadryl and Zyrtec, among dozens of others. During inspections, the FDa found a host of quality control problems at J&J's McNeil Consumer Healthcare facility in Pennsylvania, including raw contamination; a failure to track customer complaints, adequately train employees and detect sytemic problems, and a lack of procedure (see the report here).
This episode comes on the heels of another quality-control gaffe in which the same J&J unit was tagged by the FDA for failing to vigorously and properly follow up complaints that certain batches of its Tylenol Arthritis Relief Caplets had a musty smell (see here). It was a particularly embarassing moment for J&J, which provides itself on high quality (read the J&J credo). The credo, however, isn't fooling the FDA, which decided to inspect the Pennsylvania facility after the problems in the Puerto Rico plant.
For its part, the House committee plans to probe not only J&J's manufacturing lapses, but whether the FDA was vigilant enough in detecting the issues and then requiring the drugmaker to move faster in correcting the problems. In a statement, committee chair Edolphus Towns (D-NY) and ranking member Darrell Issa (R-Ca) say they expect to hold a hearing "in coming weeks."