It may be just a coincidence that DOJ released its latest policy pronouncement at the same time as the final “Daniel Craig as James Bond” movie. But like James Bond, companies in the crosshairs of a government investigation have No Time to Die, as they …
The adage that “no one is perfect” applies as equally to companies as it does to people. Before committing to a merger or acquisition with another company, a potential Buyer must conduct due diligence to identify the imperfections of a target company so the Buyer …
Companies often use rebranding to reposition and refocus their business. Sometimes they do it with great fanfare; sometimes it is done quietly and incrementally. The federal government does its own version of rebranding with each change in administration. Just before the July 4 holiday weekend, …
It is a well-accepted fact that even well run ethical and compliant organizations can have serious problems. The Sentencing Guidelines, the DOJ Manual, and the HHHS OIG–among others–all recognize that reality. In its Compliance Guidance for Pharmaceutical Manufacturers, the HHS OIG notes: The OIG recognizes that …
As has been widely covered in local and national press in and around the Washington, DC area, this month marks the once every seventeen year emergence of the Brood X cicadas. These insects are so plentiful in local areas with trees, including FDA’s aptly named …
Earlier this month, the Department of Justice announced another settlement in a Medicaid Rebate False Claims Act (FCA) case. In this case, United States ex rel. Streck v. Bristol-Myers Squibb Co., Civil Action No. 2:13-CV-7547 (E.D. Pa) Bristol Myers Squibb (BMS) agreed to pay $75 …
On December 19, 2019, the Federal Trade Commission (“FTC” or the “Agency”) filed a petition for writ of certiorari in the Supreme Court seeking review of a ruling by the Seventh Circuit case FTC v. Credit Bureau Center, LLC. A detailed overview of the background …
In the August 21 split panel decision issued in Federal Trade Commission v. Credit Bureau Center LLC, the Seventh Circuit held that section 13(b) of the Federal Trade Commission Act (“FTCA”), 15 U.S.C. § 53(b), does not authorize an award of restitution. In overturning its …
Hi-Tech Pharmaceuticals, Inc. (Hi-Tech) and its President and Chief Operating Officer filed suit in the U.S. District Court for the District of Columbia to enjoin FDA from continuing to seek removal of DMHA products from commerce through the issuance of warning letters and “pressure… to …
We have long posted about the government’s threats to hold individuals liable for actions taken on behalf of their companies, for example here, but these actions remain rare and typically are reserved for egregious, repeated, and intentional criminality. A recent indictment against two former executives, …
We previously posted about what the Agricultural Improvement Act of 2018 (commonly referred to as the Farm Bill) did, and did not, do with respect to “hemp” and CBD products derived from hemp. In that post, we noted that the Farm Bill did not preempt …
In two unrelated cases, two U.S. Courts of Appeal affirmed FDC Act-related convictions earlier this week. In United States v. Patino, the Eighth Circuit held that it was not an abuse of discretion to allow the government to introduce, in connection with a 2016 prosecution …
A biotech company facing a complete response letter (CRL) action on its NDA/BLA has no greater goal than to quickly and fully understand the deficiencies that FDA has identified in the application. Such an understanding is critical to addressing the review division’s findings through additional …
In United States of America ex rel Streck v. Allergan Inc., a federal False Claims Act (FCA) case alleging that several pharmaceutical manufacturers knowingly calculated false Average Manufacturer Prices (AMPs) that affected their Medicaid rebate payments, the U.S. Court of Appeals for the Third Circuit …
On April 3, 2018, FDA announced that it had issued a mandatory recall order for all food products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC (Triangle). FDA issued this order based on its finding that several Triangle products contained kratom …
