The torture of the McNeil Tylenol brand and the whipping of the FDA both ratcheted up a notch yesterday when Congress decided to look into J&J's most current recall of the Children's and Infants' version of the drug. The House Committee on Oversight and Government Reform says it is "deeply concerned," reports the Washington Post, and is now investigating the matter.
Committee chairman Ed Towns (D-NY) and member Darrell Issa (R-CA) want to clarify some details of the recall, particularly the mismatch between the FDA and McNeil versions of its cause and consequently the severity of the public health threat. "This is the third recall of Tylenol products in less than a year," the committee says in a press release. "The lawmakers are questioning the adequacy of FDA's inspection procedures and whether McNeil failed to investigate consumer complaints that could have identified the contamination problems."
The action by Congress comes less than a week after it chastised the regulator for its handling of the lethal heparin contamination incidents of several years ago, as we reported. U.S. Representatives Joe Barton and Michael Burgess, both Texas Republicans, asked Commissioner Margaret Hamburg in a 10-page letter, about the FDA's strategy for finding out who contaminated the heparin supply and what she plans to do once she finds out.
The Congressional attention may serve ultimately to sharpen the regulator's teeth, following some initial discomfort. But the FDA's discomfort is likely to pale next to the impact on both Tylenol and J&J should Congress find negligence on the part of the drugmaker.
- see the Post story
- here's the release from Congress