Musty odor exudes from J&J board report exonerating execs

"When the reason for a quality problem is being passed on or an excuse is given and no one gets prosecuted, it might be time to change the laws," writes Girish Malhotra of consultancy EPCOT International. A report by a "special" committee of four "independent, outside" J&J board directors concerning the company's apparent quality meltdown of the last several years that finds company execs blameless, is full of holes, he suggests. For one thing, the company continues to make musty-odor recalls. In addition, presence of the bacteria B. Cepacia from contaminated raw material and separately the production of super-potent Tylenol indicate not just unaddressed QA failures but also poor accounting practices. While acknowledging J&J culpability that somehow stops short of the executive level, the committee "needlessly points J&J's problems to FDA regulations...suggesting cGMP guidelines are vague," he writes. Column


Using AI and RWD to Uncover Rare Disease Insights, Accelerate Commercialization and Improve Patient Outcomes

Wednesday, March 24 | 2pm ET / 11am PT

Learn how transformed real world data into real world insights to assist Audentes in their development of AT132 for the treatment of XLMTM. The session reviews how IPM.ia and Audentes collaborated to uncover the XLMTM patient population.