…Interestingly, in particular for a pharmacy CSA enforcement matter, the Complaint also alleges the knowing operation of Rite-Away Pharmacy and Medical Supply #2 to unlawfully distribute controlled substances as a…

…agreement, or the pharmaceutical sales have any connection with California,” in violation of the doctrine. California disagreed and told the Court that AB 824 applies only to agreements in California…

…all misconduct by the corporation discovered during any prior domestic or foreign criminal, civil, or regulatory enforcement actions against it, including any such actions against the target company’s parent, divisions,…

…27-28 in New York.  The Forum will feature presentations on policy initiatives, federal and state enforcement efforts, and criminal and civil litigation.  Speakers include federal and state officials, trade association…

…binding on persons or entities outside the Executive Branch (including state, local, and tribal governments).” The second, and arguably more significant, policy prohibited its lawyers from civilly prosecuting companies for…

…WAC report include additional information for any drugs that had a reportable price increase during the year. The additional information includes the aggregate, company-level research and development costs, the name…

…Investigators may also conduct targeted inspections rather than routine cyclic inspections as part of the local DEA office’s annual workplan if the registrant reported controlled substance thefts/losses or were the…

…case (and related FCA cases) implicated several provisions of the FCA.  First, the court addressed the FCA’s jurisdictional public disclosure bar, and the distinct but related issue of whether the…

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…

…the FCA by engaging in an allegedly unlawful off-label marketing scheme that had caused the federal government to pay “false” claims through federal programs for the drug Marinol. This is…

…they are the victim of a life-altering accident caused by a medical device.”  A 2-page draft bill, styled as the “Medical Device Safety Act of 2008,” is being circulated on…

…practices that cause, or are likely to cause, substantial injury to consumers that they cannot avoid, and that do more harm than good.” Stating that the FTC Act “may apply”…

…typically unavailable to respondents during the show cause process and any appeal), and that the expert had reviewed the document prior to rendering testimony in the case. Though it is…

…the so-called penny pricing policy) and civil monetary penalties (“CMPs”) for knowing and intentional overcharges of 340B covered entities. (See our original post regarding the Substantive Final Rule here.) After…

…Food Safety Modernization Act (FSMA) amended the Federal Food, Drug, and Cosmetic Act (FDCA) to add section 423, granting FDA the authority to order the recall of food products (other…