…case-specific approach. Multiple organizations, including Pharmaceutical Research and Manufacturers Association of America, Advanced Medical Technology Association, and the Chamber of Commerce, have filed amicus briefs in support of DePuy. The…

…(1) additional authority to impose additional civil money penalties in administrative proceedings, (2) additional litigation authority, and/or (3) additional rulemaking authority, so that the FTC can better take advantage of…

…principles in a memorandum detailing “best practices” for federal agencies to follow in implementing rules under the Executive Order, and stating that it expects federal agencies to issue any final…

…its “Legal, Medical, Regulatory (LMR) review.”  Bayer,slip op. at 11.  That review and approval was required for every single piece of promotional material leaving Bayer.  Id.  Other companies would be…

…area, agreed to pay $200,000 to settle allegations that it violated the Controlled Substances Act (“CSA”). Austin Pharmacy to Pay $200,000 in Civil Penalties for Alleged Violations of the Controlled…

…something novel comes along. Unlike virtually all DEA/DOJ civil settlements that we are aware of, the government recently announced a settlement not with a DEA registrant but with non-registered retail…

…the sting of making the payment can be severe. A question many ask is, “Can we deduct on our federal tax return any monetary payment we make to the government?”…

…standard, rather than on the “mental state of the doctor himself or herself.” This ruling has broader implications given that many of the government’s recent criminal and civil penalty cases…

…although no patients were reported harmed. Id. at ¶3. The government alleged that Sovah failed to conduct a full physical inventory during this period which would have identified the pharmacy…

…potential transaction to determine whether, and on what terms, to proceed. There are standard topics diligence typically covers: financial, employment, environmental, tax, intellectual property, and litigation, among other things. For…

…the provision of a specific drug at no cost by a pharmaceutical manufacturer to a physician or healthcare facility violates the Federal health care program antikickback statute (“AKS”) or the…

…cannabinoids, heavy metals, microbial impurities, mycotoxins, residual pesticides, residual solvents and processing chemicals. Cannabinoid hemp products containing levels of analytes deviating from allowable limits will be considered adulterated and must…

…Initiative,” which resulted in hundreds of millions of dollars in civil penalties, administrative suspensions and revocations of registrations, and several criminal charges — all based on DEA’s claims that the…

The Supreme Court has handed down a decision in AMG Capital Management, LLC, et al. v. Federal Trade Commission, No. 19-508 (Apr. 22, 2021) [hereinafter Slip Op.], gutting the FTC’s…

…they could overheat and catch fire. The government also alleged that the Gree Companies and some of its executive officers knew of their obligation to report this information to the…