It feels like déjà vu. In 2011, FDA announced the establishment of a docket to evaluate its policies on communications and activities related to off-label uses of marketed products; late in 2014, FDA committed to issuing new guidance by the end of 2014 to address …
Just before the holidays, the First Circuit gave the defense bar a gift by applying a stringent standard to reject a fraud-on-FDA claim under the federal False Claims Act (FCA). This case effectively serves as the death knell for the fraudulent inducement theory in the …
By Anne K. Walsh & John R. Fleder – DOJ Deputy Attorney General Sally Q. Yates spoke last week before the New York City Bar Association White Collar Crime Institute to provide an update on the DOJ policy she announced in September 2015, about which we …
By Anne K. Walsh & John R. Fleder – As we reported in September, DOJ’s Deputy Attorney General Sally Quillian Yates released a seven-page memorandum announcing DOJ’s reinforced efforts to bring cases against individuals. She anticipated that DOJ would revise the U.S. Attorney’s Manual (USAM) to …
By Anne K. Walsh & John R. Fleder – It has been just over a month since the Department of Justice, via the “Yates Memorandum,” reemphasized its commitment to pursue individuals when dealing with corporate misconduct, reported here. Ever since then, FDA-regulated industry has been awaiting …
By Anne K. Walsh & John R. Fleder – The government has long repeated the mantra that it will hold individuals personally liable for the activities of their corporate employer. In the FDA-regulated arena, the government has been bolstered by the U.S. Supreme Court precedents set …
By Anne K. Walsh & John R. Fleder – Companies must proactively prepare for the strong arm tactics the government employs to investigate companies regulated by FDA. A recent case demonstrates that the federal government can act with little regard to companies seeking to represent themselves by …
