Following a series of product recalls that have embarrassed Johnson & Johnson, the company has agreed to a consent decree with the Food and Drug Administration that will put three of its plants under tight regulatory scrutiny.
As The Wall Street Journal reports, however, the agreement means that J&J will escape fines, at least for now, as well as additional plant shutdowns.
The terms of the agreement dictate that J&J subsidiary McNeil PPC, which operates the plants in question, must use an independent expert to investigate the problems and ensure that the best manufacturing practices are in place. To be in full compliance, the company also must retrain employees and demonstrate to federal regulators that it is fully investigating consumer complaints and returns of merchandise.
The heightened regulatory oversight will continue for five years.
One of the plants covered by the consent decree is temporarily closed. That facility, in Fort Washington, Pa., is the source of 135 million bottles of Tylenol pulled from the market last year.
Shut since April, the plant won’t be allowed to reopen until certified as safe by the FDA. A company spokeswoman told the Journal that the Fort Washington facility is unlikely to reopen this year.
Two other J&J plants involved in the agreement, located in Las Piedras, Puerto Rico, and Lancaster, Penn., will be able to stay in operation.
The FDA’s move contrasts with previous safety enforcement actions in recent years in which it forced drug makers like Wyeth and Abbott Laboratories to pay tens of millions of dollars in penalties. However, if J&J fails to comply with FDA requirements or abide by the agency’s schedule, it could be subject to fines of up to $15,000 a day.
“This is a strong, but necessary, step to ensure that the products manufactured by this company meet federal standards for quality, safety and purity,” said Deborah Autor, director of the FDA’s Office of Compliance.
A series of product recalls drew the FDA’s attention to J&J. In the past year, popular painkillers such as Tylenol and Motrin as well as antacids Mylanta and Rolaids all have been subjected to safety recalls. Earlier this week, J&J announced a recall of hundreds of thousands of insulin pumps, because of their potential to leak.
Sales for J&J plummeted by some $900 million in 2010 amid the recalls and subsequent controversy.


