News & Analysis as of

Off-Label Promotion

Sixth Circuit Reinforces "Stringent" Pleading Standard in False Claims Act Cases

by Jones Day on

The Sixth Circuit's recent decision in U.S. ex rel. Ibanez v. Bristol-Myers Squibb Co. reinforced Federal Rule of Civil Procedure 9(b)'s requirement that plaintiffs plead fraud "with particularity" in False Claims Act cases....more

Here Is Why The False Claims Act Is An “Awkward Vehicle” In Pharma Cases

by Reed Smith on

We have always thought that the False Claims Act resides in some sort of alternate universe when it comes to pharmaceutical products. The central concept behind the FCA is easy: The FCA penalizes anyone who presents, or...more

The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 5

In this post, I will be focusing on the intersection of off-label communications with government enforcement of health care fraud through the False Claims Act. Over the past eight years, the U.S. Department of Justice (“DOJ”)...more

Double Preemption Win in Amiodarone Litigation

by Reed Smith on

With PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013), preemption arguments in cases involving generic prescription drugs has become a little like shooting fish in...more

Value-Based Contracting for Prescription Drugs and Medical Devices: An Innovative Solution Impaired by Outdated Regulations

by Pepper Hamilton LLP on

Often lost in the cacophony of headlines surrounding rising health care costs is the promise that value-based contracting offers as a possible solution. In contrast to the traditional fee-for-service model, value-based...more

Off-Label Marketing Case Tossed

by Reed Smith on

Implied Preemption. Off-label promotion. TwIqbal. They make up a core of our posts, yet we never seem to tire of them. Maybe our readers, especially interlopers from the other side of the v., tire of reading about them,...more

Aegerion Settles Criminal and Civil Probe of Promotional Practices, REMS and HIPAA Compliance, and Patient Assistance Programs

On September 22, 2017, Aegerion Pharmaceuticals resolved a wide-ranging probe by the Department of Justice (DOJ) regarding the company’s U.S. commercial activities relating to Juxtapid, a lipid-lowering agent for the...more

FDA Weighs in on Off-Label Use and Preemption

by Reed Smith on

Back in 2013, Ramirez v. Medtronic Inc., 961 F. Supp.2d 977 (D. Ariz. 2013), made it to #9 on our worst cases of the year list – which is pretty good (actually, pretty bad) for a trial court decision. Purporting to apply...more

False Claims Act Relators Be Warned: Rule 54’s Taxable Costs Award Lies Ahead for the Overeager Relator

by Liskow & Lewis on

In a published opinion last week, the Fifth Circuit sent a reminder to would-be False Claims Act (“FCA”) relators that they better think carefully before filing suit because while they may be seeking treble damages, they may...more

The Devil is Really in the Details: FDA Issues Warning Letter to a Drug Company for Disseminating False and Misleading Information

by Arnall Golden Gregory LLP on

They’re back. The Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP), which has been relatively quiet on the enforcement front, issued a Warning Letter to a pharmaceutical company for distributing...more

The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 4

Picking up from my last installment of this series exploring the regulatory history of off-label communication, this post highlights some recent trends in FDA enforcement and guidance related to off-label promotion. Not...more

PhRMA Comment on the FDA’s Proposed Off-label Rule: The Rule of Law is the Best Medicine

by Reed Smith on

The FDA cannot get out of its own way on the issue of off-label communications. Its power to punish off-label promotion comes from an odd regulatory two-step, whereby off-label promotions are said to prove an indicated use...more

House Subcommittee on Health Opens Floor for Discussion of FDA Regulation of Off-Label Speech

by Hogan Lovells on

The House Subcommittee on Health has announced a hearing entitled “Examining Medical Product Manufacturer Communications” for Wednesday, July 12, 2017, at 10:15am EDT, in which it intends to examine two discussion-draft bills...more

Law Review Article on Off-label is On Target

by Reed Smith on

More than once we’ve said that we read law review articles so you don’t have to. We separate the wheat from the chaff. The wheat is scarce. That is because law review articles usually drown the little bits of objective...more

The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 3

This is Part 3 in my series exploring the history of FDA’s regulation of off-label communications, which has become newly relevant in light of the recent events highlighted in Part 1. In this installment, I continue...more

Ninth Circuit En Banc Panel Holds that Central Hudson Survives Sorrell

by Reed Smith on

Last week we bashed a Ninth Circuit Daubert decision. We feel a little bit bad about that, not because the decision wasn’t bashworthy – no, Wendell really is a rotten precedent – but because we hate contributing to the...more

Picking Up the Post-Preemption Pieces

by Reed Smith on

Parties often file motions in limine on fairly case-specific issues, building on the history of discovery and motions practice in the case. Applying a ruling on in limines from one case to another can be a dicey proposition...more

FCA Issues to Watch: Pharmaceutical and Device Developments | INSIDE THE FCA

by Bass, Berry & Sims PLC on

The government’s FCA enforcement efforts have continued to focus on key areas concerning the pharmaceutical and medical device industries. In fact, drug and device manufacturers accounted for nearly half of the enforcement...more

The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 2

In my last post, I introduced a series of posts that will explore FDA’s historical approach to off-label drug and device communications, how that position has evolved (or not) to the modern day, and predict where that policy...more

Guest Post – Justice for Patriots’ Fans

by Reed Smith on

This guest post by Andrew C. Bernasconi, of Counsel at Reed Smith, is about a hopeful development in a False Claims Act case we’ve already blogged about once. The previous post queried, what happens when a FCA relator,...more

The Continuing Story of Manufacturers' Off-Label Promotion of Approved or Cleared Medical Products

by Jones Day on

Prior to the end of the previous Administration, FDA released several draft guidance documents and a white paper addressing different types of communications about medical products. On January 18, 2017, FDA published two...more

The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 1

As 2017 began, FDA appeared poised to implement significant changes to the rules governing off-label communications related to drugs, biologics, and medical devices. The Agency had hosted a public hearing in November 2016 to...more

Healthcare Fraud and Abuse Review 2016

by Bass, Berry & Sims PLC on

Bass, Berry & Sims is pleased to announce the release of its fifth annual Healthcare Fraud and Abuse Review 2016. The Review, compiled by the firm’s Healthcare Fraud Task Force, is an industry-leading guide to healthcare...more

I’m Not Dead (Yet): FDA Continues to Enforce Unlawful Product Promotion

by Arnall Golden Gregory LLP on

Many of us remember the classic bit in the epic 1975 Monty Python and the Holy Grail movie, where the Dead Collector asks the pestilence-infested community to bring out its dead, and one hapless individual calls out, “I’m not...more

Arizona Enacts Law Permitting Off-Label Promotion

by Arnall Golden Gregory LLP on

As we have previously covered, the Food and Drug Administration is in the midst of reevaluating its policy on off-label promotion of medical products—that is, promotion of drugs, medical devices, and biologics for uses not...more

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