…statute already contains civil penalties for providing false drug information, and Federal False Claims Act penalties may also apply as discussed above, but Section 6 of H.R. 1839 imposes several…

…trial or specified research projects; Reasonable expenses necessary for technical training of a health care professional on the use of a medical device if a written agreement between the health…

…an action results in civil or criminal exposure. Although this sounds like an opportunity for a company to avoid having to “serve up” an individual to DOJ, corporate counsel will…

It has become almost commonplace to see a weekly announcement of a False Claims Act settlement by a major pharmaceutical or medical device manufacturer. Perhaps that is why last month’s…

…enforce the FDCA in particular cases are not subject to judicial review. With regard to LDTs, however, FDA has prospectively announced general non‑enforcement. This suspension of the FDCA is not…

…with the seller.” Also, a DEA Form 452 report must be electronically filed within 15 days after the order is shipped. According to the eBay settlement agreement, the government contends…

…$43,280 per violation of the final rule. The new rule applies not only to product labeling, but to any “mail order catalog” or “mail order promotional material” that includes a…

…drug; Total sales revenue for the prescription drug during the previous calendar year; Manufacturer’s profit attributable to the prescription drug during the previous calendar year; The introductory price of the…

…Fiscal Year 2011 Financial Services and General Government Appropriations Bill (S. 3677).  That appropriations bill was ultimately included as part of the Continuing Appropriations Act of 2011 (Pub. L. No….

…risk, trends in criminal and civil litigation, and government priorities for the new year. Sign up with the discount code SAVE15 for 15% off registration and learn more at fdli.org/enforcement….

…relevant action by a state medical or pharmacy board related to a registrant’s license or of proceedings in parallel criminal or civil cases. Typically, the Administrator will follow the appropriate…

…believe does not affect them is the federal laws and regulations that apply to identity theft. The federal government is taking the position that companies, lawyers and doctors who send…

…FDA ramps up inspections, what companies need to do to plan for and manage enforcement risk, trends in criminal and civil litigation, and government priorities for the new year. Sign…

…been a recent string of large civil monetary settlements, some in the millions of dollars, to resolve allegations that hospitals’ non-compliance with the federal Controlled Substances Act (“CSA”) and DEA…

…or making access to care more convenient for patients.  OIG also seeks comments on whether “access to care” should encompass not only clinical care but also nonclinical care that is…