This week, the Department of Justice (DOJ) intervened in a False Claims Act (FCA) lawsuit against Life Spine and two of its executives, filed in the U.S. District Court for the Southern District of New York. The lawsuit alleges that Life Spine violated the Anti-Kickback Statute by paying more than $7 million in consulting fees, royalties, and intellectual property acquisition fees to surgeons to induce them to use Life Spine products in spinal surgeries. According to the complaint, the payment of these illegal kickbacks caused the submission of false claims to federal healthcare programs, including Medicare and Medicaid, under the theory that any claim for payment submitted in connection with an illegal kickback is “false” within the meaning of the FCA.
FDA publishes new 510(K) guidance
On January 22, 2019, the FDA released nonbinding guidance expanding the Abbreviated 510(k) program used to show the safety and efficacy of medical devices. A new “safety and performance-based pathway” for certain, well understood device types, may be used by
FDA releases new guidance on off-label promotion
Last week, the U.S. Food and Drug Administration (“FDA”) released two guidance documents that relate to sharing of certain information about drugs and medical devices, including economic information about unapproved products and unapproved uses, as well as information not included
FDA commissioner discusses upcoming guidance to modernize its framework for medical device review
On December 11, 2017, the U.S. Food and Drug Administration (“FDA”) Commissioner, Scott Gottlieb, posted Advancing Policies to Promote Safe, Effective MedTech Innovation on FDA’s blog, FDA Voice and discussed FDA’s plans to modernize its policy framework for the review
Ontario introduces legislation requiring disclosure of payments to physicians
Following a consultation, legislation was introduced in the Ontario Legislature on September 27, 2017 that will require pharmaceutical and medical device manufacturers to disclose financial relationships to healthcare professionals and organizations.
The Health Sector Payment Transparency Act is one
FDA issues final guidance on postmarket medical device cybersecurity
On December 28, 2016, the U.S. Food and Drug Administration (FDA) released final guidance on the management of cybersecurity vulnerabilities for marketed and distributed medical devices. The guidance establishes a risk-based approach for the reporting of medical device cybersecurity vulnerabilities