Drug Manufacturers

News & Analysis as of

The Proposed 340B Guidance:  Who is the Biggest Loser?

We have now had more than 30 days to digest HRSA’s proposed 340B Drug Pricing Program Omnibus Guidance (“Proposed Guidance”), intended to clarify expectations and provide guidance on key issues in the 340B Program. There are...more

Heedless Heeding Presumptions – How New York Law Became a Morass

Ever since this blog started, we’ve made plain that we have no use for the so-called “heeding presumption.” This presumption posits that, because under Restatement §402A, comment j, a defendant providing an adequate warning...more

Cymbalta Judge Severs Claims and Smacks Down Plaintiff Lawyers’ Self-Created "Quagmire"

Ninety-nine years ago today (October 7) Georgia Tech administered the most lop-sided beat-down in college football history, edging Cumberland University 222-0. (By the way, who was the head coach of Georgia Tech who presided...more

The FDA Tiptoes – and Congress Splashes Into – the 21st Century

Here are a couple of non-litigation related matters that we thought our readers need to know about. First, the FDA. We’ve pointed out before that the FDA’s “intended use” regulations for drugs (21 C.F.R. §201.128) and...more

"The Future of Government Regulation, Enforcement of Off-Label Promotion"

Three years ago, in United States v. Caronia, the U.S. Court of Appeals for the Second Circuit held that the Federal Food, Drug and Cosmetic Act (FDCA) neither prohibits nor criminalizes truthful, nonmisleading speech that...more

HHS Issues Proposed 340B Program Omnibus Guidance: Five Things to Watch

The 340B Drug Pricing Program (340B Program), established by Section 602 of the Veterans Health Care Act of 1992, is administered by the Health Resources and Services Administration (HRSA) of HHS. The 340B Program requires...more

Illinois Federal Court “Sanctions” Fraudulent Joinder of Pharmacies

We learned a new word the other day while watching TV: Autoantonym. An autoantonym is a word that means one thing, but it also means the opposite. The word is its own antonym, and it is remarkably easy to think of examples...more

MedPAC Convenes to Discuss Open Payments, Payment for Post-Acute Care, and Other Issues

On September 10-11, 2015, MedPAC held a meeting to discuss several issues related to the Medicare program, including (1) improving the Open Payments program, which makes public the payments from drug and device manufacturers...more

Drug and Device Companies May Soon Face Less Burdensome FDA Approval Process

On July 10, 2015, Congress passed H.R. 6, the 21st Century Cures Act, with a bipartisan vote of 344 to 77. The 352-page bill seeks to make the U.S. Food and Drug Administration (FDA) drug and device approval process less...more

Solid "No Designer Liability" Decision in a Non-Pharma Case in the Eastern District of Pennsylvania

On September 13th, we, as Drug and Device Law Jews, celebrated Rosh Hashanah, the Jewish New Year. Normally, we host dinner for 20 or so members of our extended family. This year, the entire day before the holiday was...more

HRSA Publishes Proposed 340B Drug Pricing Program Omnibus Guidance - Comments Due to HRSA on or before Tuesday, October 27, 2015

On Friday, August 28, 2015, the Health Resources and Services Administration (“HRSA” or “the Agency”) published in the Federal Register Notice of its proposed “omnibus” or “mega” guidance (“Proposed Guidance”) regarding...more

Blog: HRSA 340B Drug Discount Program “Omnibus” Regulation Published – Comment Period Open Until October 2015

On Friday, August 28, 2015, the U.S. Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) proposed its long-awaited “Omnibus” regulation for the 340B Drug Discount Program in the...more

340B Omnibus Guidance Would Significantly Narrow the Pool of Eligible Patients

New guidance from the Health Resources Services Administration (HRSA) clarifying certain definitions integral to the 340B Drug Pricing Program (“340B Program”) will significantly limit the number of patients eligible to...more

Batting Down Generic Plaintiffs’ Amarin Hail Mary Pass

We received a couple of odd anonymous comments to our “breaking news” post about the Amarin First Amendment victory for truthful off-label promotion. Both of them raised the same suggestion: “Does the logic of this opinion...more

Healthcare & Life Sciences Private Equity Deal Tracker: Syndax Secures $80 Million in Financing

Syndax, based in Waltham, Mass., is a clinical stage biopharmaceutical company. It is developing entinostat, an investigational, targeted, epigenetic immunomodulator, as a combination therapy in multiple cancer indications...more

Preemption (and Other Things) Defanging Depakote Claims

It wasn’t a complete win, but the summary judgment outcome in Rheinfrank v. Abbott Laboratories, Inc., ___ F. Supp.3d ___, 2015 WL 4743056 (S.D. Ohio Aug. 10, 2015), has to put a spring in the step of the defendants as they...more

Central District of California "Discontinues" Much of Plaintiffs' Experts' Testimony in Cymbalta "Discontinuation Symptoms" Case

“I’m not a doctor, but I play one on TV” – shorthand for “I am pretending to know what I’m talking about, but I really don’t.” We have blogged frequently about experts inclined to such pretense and about courts’ varying...more

OIG Issues Two Favorable Advisory Opinions

OIG recently issued two favorable advisory opinions. On August 12, 2015, OIG approved a program that provides a free cancer drug approved under the FDA’s Breakthrough Therapy Designation to patients who meet certain criteria...more

Off-Label Marketing and the False Claims Act

In a post published earlier this week this week our colleagues Brian Dunphy and Joanne Hawana examined key issues in the recent Amarin decision from the Southern District Court of the New York. The August 7th ruling provided...more

The Government’s Generic Price-Fixing Investigation Targets Allergan’s Actavis Unit

This is our fourth post on the DOJ’s expanding investigation into possible price fixing by generic drug manufacturers. (Click here, here, and here to read our prior posts.) Since our last update, the DOJ has subpoenaed...more

First Amendment Protects Truthful Off-Label Speech by Drug Manufacturers

Pharmaceutical manufacturers have likely taken note of Amarin Pharma Inc.’s recent success in a pre-enforcement legal challenge against the Food and Drug Administration (FDA or the Agency). On August 7, 2015, Amarin obtained...more

Animal supplements still in limbo, facing increased FDA scrutiny

The thousands of food, agriculture and life sciences companies regulated by the federal government already face a barrage of complicated regulations. Add in significant regulatory uncertainty and a major reorganization of the...more

More CAFA “Mass Action” Gamesmanship In The Ninth Circuit

Permitted gamesmanship versus prohibited conduct. That is the dichotomy that one district judge adopted to describe the transparent forum manipulation that some plaintiffs undertake under CAFA. To be honest, neither...more

Guest Post - Impossibility Preemption for Innovator Drug Manufacturers: Where Are We Now?

Today we have a guest post (her second - she's a glutton for punishment) from fellow Reed Smith associate Danielle Devens. This one brings together recent precedent recognizing post-Levine preemption in cases involving...more

FDA Cites Drug Company for Kim Kardashian Endorsement

This week might have been the first time that an FDA regulatory issue hit the headlines on TMZ and other “celebrity watcher” websites. In an August 7 Warning Letter sent to the drug company Duchesnay, Inc., FDA complains...more

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