What Should You Expect with Enforcement of the False Claims Act?

Gibson Dunn’s 2018 Mid-Year False Claims Act Update includes several notable developments of interest to medical device manufacturers. In addition to covering recent enforcement activity, the update explains this year’s memorandum from then-Associate Attorney General Rachel Brand (known as the “Brand Memo”) that "prohibits DOJ attorneys from bringing civil enforcement actions based on alleged noncompliance with informal agency guidance," explains Jonathan Phillips, a partner in the office of Gibson, Dunn & Crutcher. To dig deeper into this issue and other activities involving the False Claims Act (FCA), MD+DI asked Phillips a few medtech-focused questions. Phillips focuses on FDA and healthcare compliance, enforcement, and litigation, among other matters.   Can you explain how the authority of the DOJ and FDA intersect when it comes to the False Claims Act (FCA)? Are there any new developments? Phillips: DOJ has exclusive enforcement authority over False Claims Act matters; FDA does not (and cannot) pursue these matters itself. However, FDA personnel, including in the Office of Chief Counsel, may have an advisory role in False Claims Act matters that are predicated on allegations of off-label promotion or other conduct that implicates or overlaps with the Federal Food Drug & Cosmetic Act. Some notable FCA litigation in recent years has focused on the extent to w...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news