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I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - 2020 Year in Review on FDA’s Enforcement of Rx Drug Promotions & Trends
Part Two: The MFN Drug Pricing Rule and the Rebate Rule: Where Do We Go From Here?
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Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more
The Supreme Court recently issued a significant decision clarifying what it means to “knowingly” submit a false claim under the False Claims Act. At issue in United States ex rel. Schutte v. SuperValu Inc. were allegations...more
The story of one of the most significant False Claims Act (“FCA”) cases this year began nearly two decades ago. Between 2006 and 2012, SuperValu, Inc.—which operated thousands of pharmacies nationwide—offered a “price match...more
On July 11, 2022, Teva filed a cert petition with the Supreme Court, seeking review of the Federal Circuit’s split per curiam opinion holding that Teva’s label for its generic drug Coreg induced doctors to infringe a GSK...more
In December, the Supreme Court requested that U.S. Solicitor General Elizabeth Prelogar file a brief in John Doe 1 v. Express Scripts Inc., weighing in on whether the Court should hear a case about prescription drug costs. If...more
A number of health care related cases have come before the United States Supreme Court this session, including two cases on topics we have previously reported on: Medicare’s site-neutral payment policy for off-campus...more
On June 28, 2021, the United States Supreme Court denied review of a Seventh Circuit decision affirming the Department of Justice (“DOJ”)-requested dismissal of a False Claims Act (“FCA”) suit alleging a drug kickback scheme....more
FDA regulation of biomedical products can be like a very complex game theory decision tree. Choices made at each intersection impact the ultimate regulatory framework under which any given product is developed, seeks...more
The solicitor general filed an amicus brief in the U.S. Supreme Court last month supporting the relators’ opposition to certiorari in Gilead Sciences, Inc. v. United States ex rel. Campie, et al., No. 17-936. Yet the...more
On November 30, 2018, the Solicitor General of the United States filed an amicus curiae brief in the closely watched False Claims Act (FCA) lawsuit, Gilead Sciences Inc. v. U.S. ex rel. Campie. In what appears to be an...more
On March 15, 2018, Skadden hosted its Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar in Palo Alto, California, which focused on U.S. enforcement issues faced by companies throughout the industry. The...more