Health Care Law

/Tag:Health Care Law

Client Alert – Members of Congress Call for Review of FDA Guidance on Compounding under Section 503A

June 27, 2017 - Earlier this year, we focused one of our client alerts on a new Guidance issued by the Food and Drug Administration (FDA) concerning certain prescription requirements for compounding human drug products under section 503A of the Federal Food, Drug, and Cosmetic Act. See "FDA Issues Guidance on Prescription Requirement for Compounded [...]

Client Alert: Former Heritage Pharmaceuticals Execs Admit to Price Fixing

Former Heritage Pharmaceuticals Execs Admit to Price Fixing Government Continues to Focus on Generic Drug Industry Since early December of 2016, we've been tracking federal price fixing charges brought against two ex-pharmaceutical executives – Jeffrey Glazer and Jason Malek – both formerly of Heritage Pharmaceuticals.  On January 9, 2017, the two entered guilty pleas in [...]

Client Alert – Twenty States File Suit against Generic Drug Makers-Companies Accused of Collusion and Price-Fixing

On December 14, 2016, we shared the news that two former Heritage Pharmaceuticals (Heritage) executives had been charged by the U.S. Department of Justice in a generic drug pricing-fixing scheme—noting that the investigation was ongoing at both the state and federal levels and could touch dozens of other companies. That statement appears to be prescient, [...]

Government Recovers Over $4.7 Billion from False Claims Act Cases in FY 2016

Government Recovers Over $4.7 Billion from False Claims Act Cases in FY 2016 December 15, 2016 — In a mid-week announcement, the U.S. Department of Justice (DOJ) revealed that during fiscal year 2016 it had recovered, via settlements and judgments in civil cases under the False Claims Act (FCA), a near-record $4.7 billion—the third highest annual [...]