Johnson & Johnson is currently facing a number of regulatory inquiries that stem from a host of drug recalls by J&J subsidiary McNeil Consumer Healthcare, which began recalling eight separate drugs in September 2009. After the situation did not resolve itself, the FDA held a meeting with J&J executives in February and a Congressional hearing was held in May. Investigations currently remain ongoing with the FDA, and recently J&J announced it is being investigated by several state attorneys general and has received a subpoena from a federal grand jury in Pennsylvania. Chad Landmon, Partner at Axinn, questioned how this will end for J&J, saying, “The FDA is very serious and concerned about the recall and the allegations being made against the firm.” Landmon noted that as the investigations progress J&J could end up paying a hefty fine, somewhere in the triple digit millions. Landmon also told Pharmawire that the worst case scenario for J&J is if the firm is subject to criminal action against it’s executives for purposefully violating FDA rules.

The article, titled, “J&J could face further regulatory action if intent of GMP violation proven – attorneys,” was published by Pharmawire on August 24, 2010.