News & Analysis as of

Off-Label Use Pharmaceutical Industry

The Opioid Epidemic – What Kind of a Problem Is It?

by Reed Smith on

We know that our blogposts are carried by legal aggregating services, such as Lexology and JDSupra. Some of you may even be reading this post via one of these services. In addition to writing for them, we actually read...more

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

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

Seventh Circuit Curtails RICO Application to Third-Party Payor Off-Label Suits

by Reed Smith on

If you want to insult and annoy someone, consider suing them under the Racketeering Influenced and Corrupt Organizations Act, 18 U.S.C. section 1964. That law is charmingly known as RICO, in an allusion to the big bad in the...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

Reimbursement Manager Pleads Guilty for Prior Authorization Process Issues

by Bass, Berry & Sims PLC on

On Monday, June 19, 2017, Elizabeth Gurrieri became the second former employee of Insys Therapeutics (Insys) to plead guilty to federal anti-kickback charges related to the drug Subsys, an expensive fentanyl-based painkiller....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

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

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

What If We Win? Off-Label Promotion & Product Liability

by Reed Smith on

Since the nomination of Dr. Scott Gottlieb to head the FDA, we’ve seen quite a few references to his opposition to the current FDA prohibition against off-label promotion – regardless of the truth of the promotion itself. We...more

FDA Publishes Guidance on Off-Label Use Communications

by BakerHostetler on

The U.S. Food and Drug Administration (FDA) recently released two draft guidance documents and a memorandum related to off-label communications and the FDA’s power to regulate such communications. The publications are the...more

FDA Hardens Its Stance on Intended Use and Off-Label Use and Industry Responds

From 2015 to 2016, FDA appeared to open the door to loosening the standards around intended use and off-label use, but recent rule-making and public comments suggest that FDA is becoming more sclerotic instead of flexible....more

Beyond the Label: FDA Addresses Permissible Scope of Communications With Payors and Physicians

by Pepper Hamilton LLP on

The draft guidances create a grey area between “on-label” and “off-label” communications that will require careful navigation as manufacturers develop HCEI analyses and promotional communications....more

FDA Clarifies “Intended Use” Regulations: Knowledge Alone ? Intent, But Knowledge Certainly Can Be One Element in Establishing the...

by Hogan Lovells on

In its January 9, 2017 final rule addressing when tobacco products may be regulated as drugs, devices, or combination products, the Food and Drug Administration (“FDA” or “The Agency”) amended the intended use regulations for...more

Healthcare Law Update: December 2016

by Holland & Knight LLP on

Prompt Payment Discounts Not an Anti-Kickback Statute Violation - In United States of Am. et al. ex rel. Ruscher v. Omnicare, No. 15-20629, 2016 WL 6407128 (5th Cir. Oct. 28, 2016), the court of appeals affirmed summary...more

The First Amendment Does Not Protect All Off-Label Drug Promotion

by Fish & Richardson on

FDA is considering making off-label promotion easier, consistent with recent case law. The drug and biologics industry is also proposing an ease up of FDA regulation, which would allow it to “responsibly” promote new drug...more

This Is How A False Claims Act Case Works—And Fails

by Reed Smith on

It took us a long time to understand how off-label promotion of prescription drugs had anything to do with the False Claims Act, and we’re still not so sure that the two are a fit. The FCA penalizes anyone who presents, or...more

FDA Hosts Public Meeting on Off-Label Communications

by McDermott Will & Emery on

The US Food and Drug Administration (FDA) recently held a two-day public meeting on Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products (off-label communications), which offered...more

FDA Holds Public Hearing on Manufacturer Communication of Scientific and Medical Information

by Ropes & Gray LLP on

On November 9 and 10, 2016, FDA held a public hearing to obtain input on manufacturer communications involving unapproved uses of approved or cleared medical products (i.e., “off-label” uses). The hearing was moderated by...more

Upcoming FDA Public Meeting on Speech and Medical Products

by Reed Smith on

As a reminder, the Food and Drug Administration (FDA) is holding a two-day public meeting on November 9 and 10, 2016 regarding “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products.” ...more

Update on Prosecution for Truthful Off-Label Promotion

by Reed Smith on

We have been following issues related to the interplay of off-label use, manufacturer statements about off-label use, the First Amendment, and FDA enforcement for a long time. (Like here, here, and here, among many posts.) ...more

Off-Label Promotion —To Speak or Not To Speak?

by Stinson Leonard Street on

Earlier this month, the U.S. Food and Drug Administration (FDA) announced a two day public hearing to take place November 9 and 10 aimed at obtaining input from industry to help shape FDA's policy regarding communications...more

FDA Announces Dates for Long-Awaited Public Hearing on Its Regulation of Off-Label Communications

Times, They Are A-Changin’ - On Wednesday, FDA announced that it will hold a two-day public hearing on November 9th and 10th to obtain input from a broad cross-section of the health care industry, including...more

Product Liability Update: April 2016

by Foley Hoag LLP on

Massachusetts Superior Court Rejects “Innovator Liability” Failureto-Warn Claim, Holds Branded Pharmaceutical Manufacturer Owed No Duty to Plaintiff Alleging Injury From Equivalent Generic Drug That Copied Defendant’s...more

Another Off-Label Promotion Third Party Payor Case Lacks Causation

by Reed Smith on

July in D.C. is hot and sticky. When scorching day follows scorching day, area residents look forward to evening thunderstorms, not just to water otherwise thirsty lawns and gardens but to cool things down. Lightning can be...more

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