News & Analysis as of

Distributors Pharmaceutical Industry

FDA Delays Enforcement of Prescription Drug Product Identifier and Related Requirements

Facing pressure from stakeholders and technological realities, the U.S. Food and Drug Administration has again delayed its enforcement of parts of the Drug Supply Chain Security Act (DSCSA). As we discussed in a prior post,...more

US Supreme Court strikes death blow against forum shopping in mass actions by limiting personal jurisdiction

by DLA Piper on

On Monday, the US Supreme Court continued its recent trend of contracting personal jurisdiction in Bristol-Myers Squibb Co. v. Superior Court of California, San Francisco County, No. 16-466, 582 U.S. ___ (2017) by holding...more

Supreme Court Tightens Personal Jurisdiction Requirements

by Benesch on

Determining whether a nonresident defendant is subject to a forum state’s jurisdiction became clearer on June 19, 2017, when the United States Supreme Court announced its decision in Bristol-Myers Squibb Co. v. Superior Court...more

Form Drug Distribution Services Agreements May Not Be Formulaic

by Arnall Golden Gregory LLP on

Vanilla-looking form agreements may contain or omit terms that are important to one or both parties. We were recently reminded of the danger of entering into form pharmaceutical distribution services agreements. Although...more

French Legal and Regulatory Update – December 2016

by Hogan Lovells on

The Paris office of Hogan Lovells is pleased to provide this English language edition of our monthly e-newsletter, which offers a legal and regulatory update covering France and Europe for December 2016. Please see full...more

Expanded Requirements for Expanded Access: The 21st Century Cures Act Places New Requirements on Manufacturers and Distributors

by Arnall Golden Gregory LLP on

The 21st Century Cures Act (Cures Act) makes a number of changes affecting the pharmaceutical and biologics industries, and AGG previously has written on some of these changes. This update will focus on how the Cures Act...more

Antitrust Matters - September 2015

by DLA Piper on

Antitrust investigations are no longer limited to a nation’s borders, or even to a region. Enforcers are more and more sharing information and coordinating their investigative efforts as they strive to uniformly enforce the...more

EPA Proposes New Rules for Pharmaceutical Wastes That Qualify as RCRA Hazardous Wastes

by Beveridge & Diamond PC on

On August 31, 2015, the Administrator of the U.S. Environmental Protection Agency (“EPA” or the “Agency”) signed a proposed rule that would establish special management standards for pharmaceutical wastes that are classified...more

Drug Disposal Ordinance: Supreme Court Writ Filed

by Reed Smith on

On December 29, 2014, the Pharmaceutical Research and Manufacturers of America (“PhRMA”), the Biotechnology Industry Organization (“BIO”), and the Generic Pharmaceutical Association (“GPhA”) jointly filed a Petition for a...more

Damages in “Aggravated Breach” Cases

by Ellis & Winters LLP on

We have written before about the “aggravated breach of contract” theory under N.C. Gen. Stat. § 75-1.1. This theory can make a breach of contract a springboard to treble damages....more

GPhA Issues Statement Regarding Proposed IP Provisions of Trans-Pacific Partnership Agreement

The Generic Pharmaceutical Association (GPhA) issued a statement today regarding ongoing talks between major Pacific Rim countries (including the U.S.) related to the proposed Trans-Pacific Partnership Agreement. This trade...more

False Claims Act Update: GSA Contractor Reasonably Relied Upon Distributor Certifications Of Product Origin And Trade Agreements...

by King & Spalding on

The United States Court of Appeals for the District of Columbia Circuit recently upheld a District Court’s dismissal of a False Claims Act (FCA) complaint against a federal government contractor in a case that will be of...more

Drug Distributor and Pharmacies Obtain Partial Dismissal of State and Federal FCA Claims

On June 10, 2014, a New York federal court dismissed, in part, state and federal False Claims Act (FCA) claims brought against Novartis Pharmaceuticals Corporation and pharmacies to which it distributed (CVS Caremark Corp.,...more

Commission-Based Sales Agreements for Medical Supplies and Equipment: More Whistleblower Activity on the Horizon? - A Wide Range...

by Holland & Knight LLP on

The common industry practice of compensating independent contractor sales representatives on a "percentage of sales" commission basis may be creating an enhanced risk of False Claims Act liability for illegal kickbacks in...more

No Standing for Illegal Drugs: Third Circuit Limits Antitrust Standing for Foreign Drug Manufacturers Absent FDA Approval

by BakerHostetler on

A Third Circuit panel recently ruled that a foreign drug manufacturer lacks antitrust standing when it could only sell its product in the United States through a distributor....more

15 Results
|
View per page
Page: of 1
Cybersecurity

"My best business intelligence,
in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.