Beginning in September 2009, I watched with increasing surprise as Johnson & Johnson (J&J) recalled more and more of its products. As the recalls kept coming, my surprise turned to amazement that some of the company’s facilities (particularly the one at Fort Washington, Pennsylvania) could have been maintained and run in such an apparently haphazard way. As time went on, my amazement ebbed, and the continuing stream of recalls elicited little more than a shrug.
Then, last week, the other shoe dropped. FDA and J&J signed a consent decree of permanent injunction that prevents the company from manufacturing or shipping drugs from its Fort Washington facility until it complies with current good manufacturing practice requirements. J&J had closed that facility in April 2010 and submitted a Comprehensive Action Plan to FDA in July 2010 to improve quality systems at its US manufacturing facilities. Subsequent recalls seemed to indicate that the company’s measures were insufficient, however.
J&J’s problems are not limited to Fort Washington—from 2009 to 2010, FDA inspectors found violations of the Federal Food, Drug, and Cosmetic Act at the company’s Las Piedras, Puerto Rico, and Lancaster, Pennsylvania, facilities. The consent decree requires J&J to adhere to a strict timetable to bring these sites into compliance.
Until I read news of the consent decree, I thought that the only fallout from the company’s manufacturing violations would be CEO Bill Weldon’s 3% raise. In fairness, I should mention that his bonus was cut to $1.97 million, but I should also mention that his bonus is still larger than his salary.
The consent decree reassures me that FDA takes J&J’s violations seriously, and I’m more optimistic that the company will get its house in order now that it faces focused government scrutiny. Our health is too important for FDA to tolerate anything less than diligence on the part of any manufacturer. If nothing else, J&J should be worried about healing the black eye that it has given itself. If the company follows the advice of its independent investigator, J&J may be able to make the improvements needed to regain FDA’s approval and customers’ trust.