In addition to failed plant inspections and subsequent warning letters, the run-up to last week's FDA/McNeil consent decree announcement included meetings and teleconferences among McNeil, J&J and the FDA dating back to 2009. McNeil submitted a comprehensive remediation plan last July, but even that has fallen short of convincing the regulator that the company can get its manufacturing act together.
"Recent FDA inspections have confirmed that violations persist and additional work is needed to fully address deficiencies and achieve sustained compliance with the law," the Justice Department says in a complaint, according to Bloomberg.
The FDA told McNeil Thursday that it would proceed with a civil lawsuit against the company, as well as its VPs for quality and for OTC operations. But McNeil agreed to the consent decree terms instead, allowing it to sidestep the lawsuit, says CNN.
The decree effectively relieves McNeil of its responsibility to fix its broken manufacturing and quality systems, says Donald Riker, president at On Point Advisors [see related story]. "It allows the third-party [GMP consultancy] backed by the court to tell J&J what the goals are. It removes them from acting independently."
Nonetheless, "the objective is to get these guys back on track," says Riker. So the consultancy is more likely to build on last July's remediation plan rather than starting anew.
Johnson & Johnson and CEO Bill Weldon (photo) became highly visible in the Tylenol recalls through last year's two congressional hearings. The consent decree, however, names only McNeil. "Although this is a systemic failure and J&J has demonstrated its quality systems are sloppy throughout the corporation, the most egregious failures are in the OTC plants. These are what need to be under the decree," Riker says.