…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…

…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…

…and place all food safety responsibilities in a single federal agency, announced on September 28th that he would propose an amendment to sunset all food safety agencies by 2010.  Sen….

…more immediate and aggressive enforcement action by FDA.  Against traditional pharmaceutical manufacturers, FDA has, in its armamentarium, civil (e.g., TRO, seizure) and criminal (FD&C Act prosecution) judicial actions that can…

…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…

…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…

…of the earlier enforcement actions relating to HIPAA, the disclosure of PHI was unintentional and not made for personal gain. It is also notable given it occurred in a clinical…

…in China, and Carmen M. Shepard, Senior Vice President of Global Policy and Regulatory Counsel at Mylan Inc., who will provide industry perspective on these issues. Ms. Shepard will also…

…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…

…Sciences, Inc. (the factual and procedural background is summarized here and here). In short, the relators allege the company made misrepresentations to FDA that led to product approval and ultimately…

…program antikickback statute (“AKS”, 42 USC 1320a-7b(b)), the OIG recognized that the program operates entirely outside of all Federal health care programs, meaning that patients obtain the product without using…

…by the Pharmaceutical Research and Manufacturers of America (“PhRMA”), the Biotechnology Industry Organization (“BIO”), and the Generic Pharmaceutical Association (“GPhA”) challenging a “first in the nation” Safe Drug Disposal Ordinance…

By Kurt R. Karst –       The Pharmaceutical Research and Manufacturers of America (“PhRMA”), the Biotechnology Industry Organization (“BIO”), and the Generic Pharmaceutical Association (“GPhA”) share some common ground.  All three…

…$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…

…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….