The world’s largest manufacturer of generic pharmaceuticals, Israeli-based Teva Pharmaceutical Industries Ltd. (“Teva International”), and certain of its global subsidiaries agreed to pay nearly US$520 million and enter into a Deferred Prosecution Agreement (“DPA”) to resolve allegations that the companies
The U.S. Food and Drug Administration (“FDA”) regulates the use of social media to disseminate information about prescription drugs and medical devices. Our firm sister blog, the Social Media Law Bulletin, previously covered the social media guidance released by the
CMS announced on December 15, 2016 that it will not pursue its plans to finalize a proposed rule that would have created a pilot program to test a new Medicare Part B prescription drug reimbursement model. CMS explained that while
The Food and Drug Administration (“FDA”) released its final guidance on medical device safety on December 14, 2016, titled “Public Notification of Emerging Postmarket Medical Device Signals (Emerging Signals).” The final guidance comes almost a year after FDA issued a
The Department of Justice (“DOJ”) announced yesterday that it recovered over $4.7 billion in fiscal year 2016 in civil cases involving claims of fraud against the government under the False Claims Act (“FCA”). This is the third largest annual recovery
On December 13th, President Obama signed into law the 21st Century Cures Act. The legislation authorizes $4.8 billion for the National Institutes of Health to fund new initiatives in precision medicine, cancer, neuroscience, and regenerative medicine. The bill also
Health Canada is contemplating mandatory front-of-package (FOP) labelling for prepackaged foods high in “nutrients of public concern”, namely sugars, sodium and saturated fat. This is one of the key initiatives put forward by Health Canada as part of its Health
On December 7, 2016, the Office of Inspector General for the U.S. Department of Health and Human Services (“OIG”) issued a Policy Statement that increased the thresholds for gifts to Medicare and Medicaid beneficiaries to be considered “nominal” under the
On October 17, 2016, a US federal trial court in the District of Columbia ruled that a competitor may pursue a Lanham Act claim for false advertising due to a container of black pepper. Watkins Inc. v. McCormick & Co.
The US Food and Drug Administration (“FDA”) announced on November 18, 2016 that it will not release a final guidance to regulate laboratory developed tests (“LDTs”), in vitro diagnostic tests designed, manufactured, and used within a single laboratory. The announcement