Prescription Drugs

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Insurance Antitrust Legal News - November 2014 - Volume 3 - Number 6

Plaintiff Files Third Amended Antitrust Claim Against Highmark - A long running antitrust dispute in Western Pennsylvania continued on October 1, when a Pennsylvania hotel (Cole’s Wexford Hotel) filed a third amended...more

HRSA Withdraws 340B Program Proposed Rule

On November 14, 2014, the U.S. Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) withdrew a proposed rule that would have provided guidance on a variety of topics related to the...more

The Seventh Circuit Rejects Medicaid False Claims Act Suit

The United States Court of Appeals for the Seventh Circuit affirmed the dismissal of a False Claims Act (“FCA”) case against Shopko Operating Stores, LLC, in which a former Shopko pharmacist asserted Medicaid billing...more

HRSA Abandons Plans for “Mega-Rule” for 340B Drug Pricing Program

Based on a notice posted on its Office of Pharmacy Affairs (OPA) website, the Health Resources and Services Administration (HRSA) intends to issue in 2015 proposed guidance addressing key policy issues raised by the various...more

The 340B Mega-Reg is Dead

With all due credit to the Coroner from the Wizard of Oz, like the Wicked Witch of the East crushed by Dorothy’s house, the 340B Drug Discount Program mega-reg is “not only merely dead, it’s really most sincerely dead.” And...more

HHS Withdraws Proposed 340B Drug Pricing Program "Mega Regs": Further Guidance Forthcoming

The Department of Health and Human Services (HHS) has withdrawn its greatly anticipated 340B Drug Pricing Program (340B Program) proposed regulations. The proposed regulations, nicknamed the 340B Program “Mega-Regs,” had been...more

Proposed Mega Rule Abandoned Under the 340B program

In very broad terms, the 340B program allows some safety-net health care providers to provide qualifying patients with affordable prescription drugs. In January, the Office of Pharmacy Affairs (OPA) of the Health Resources...more

Public Outcry Over Generic Price Hikes Spurs Criminal Investigations

Drug manufacturers Impax Laboratories and Lannett Company have come under public scrutiny and, more recently, criminal investigation for their recent generic drug price increases. The companies disclosed in recent SEC filings...more

EP Committee Study on Legislative Areas of the TTIP Addresses Nanomaterials

The European Parliament (EP) Committee on Environment, Public Health, and Food Safety (ENVI) has posted a study entitled ENVI Relevant Legislative Areas of the EU-US Trade and Investment Partnership Negotiations (TTIP). The...more

FDA Publishes Second Draft Guidance for Further Clarification of Drug Supply Chain Security Act

Earlier this year, the U.S. Food and Drug Administration (FDA) requested information and commentary for the implementation of the Drug Supply Chain Security Act (DSCSA) that in part "establishes a Federal system for tracing...more

Next Steps in the Dance: Amgen Files Citizen Petition at FDA Requesting Mandatory Compliance with BPCIA Patent Procedures

Amgen, Inc. (“Amgen”) has brought the discussion of the procedure for biosimilar applications from the courts to the FDA by filing a Citizen Petition (Docket No. FDA-2014-P-1771) on October 29, 2014 (“Petition”) requesting...more

FDA's Final Guidance on Determination of Five-Year NCE Exclusivity for Certain Fixed-Combination Drug Products Under Federal FDCA

The U.S. Food and Drug Administration (FDA) recently published its final Guidance for Industry detailing circumstances under which a fixed-combination drug product (FCD) may be entitled to five-year new chemical entity (NCE)...more

"Generic" Logic Helps Branded Drug Achieve Dismissal

A federal district court has held that design defect claims against a brand pharmaceutical manufacturer are preempted by federal law. Booker v. Johnson & Johnson, No. 3:12 oe 40000, 2014 WL 5113305 (N.D. Ohio Oct. 10,...more

Pennsylvania Workers Compensation Prescription Drug Reimbursement Restrictions

On October 27, 2014, the Governor signed Pennsylvania General Assembly enacted House Bill 1846, which limits both the authority and the reimbursement of physicians and providers other than pharmacies for prescription drugs. ...more

Beginning to Close the POM Circle? – POM Wonderful and Drug Advertising: JHP Pharmaceuticals

Earlier this year, in POM Wonderful LLC v. Coca-Cola Co.,[1] the Supreme Court examined the interaction between the Lanham Act’s prohibition against false advertising and the FDCA’s prohibition against food, drug and...more

The Era of Generic Biologic Drugs Has Officially Begun: An Update on U.S. Biosimilars  [Video]

Paul A. Calvo, Ph.D., director at the intellectual property law firm Sterne, Kessler, Goldstein & Fox, P.L.L.C., discusses the success of generic biologic manufacturers at the FDA and in the courts as the era of generic...more

Pharmaceutical manufacturers beware: HHS OIG issues warning about copay coupon programs

The Office of Inspector General of the Department of Health and Human Services recently issued a warning to pharmaceutical manufacturers, reminding them that copay coupons used for drugs purchased through federal healthcare...more

Bernstein Shur Business and Commercial Litigation Newsletter #45

We are pleased to present the 45th edition of the Bernstein Shur Business and Commercial Litigation Newsletter. This month, we highlight recent cases that address the stay of discovery in securities litigation, the failure to...more

Questioning employees about prescription drugs that could affect performance and safety

Employers often have policies and procedures (frequently included in a drug testing policy) that require their employees to disclose the lawful use of prescription drugs (i.e., per the advice and prescription of a licensed...more

Report Shows CMP Enforcement Actions On the Rise Against Part C and Part D Sponsors

A new report issued October 16, 2014 by the Medicare Parts C & D Oversight and Enforcement Group (MOEG) reveals that civil monetary penalty (CMP) enforcement actions in these two programs more than tripled from 2012 to 2013....more

Takeda Pharm. Co., Ltd. v. Mylan Inc.

Nature of the Case and Issue(s) Presented: The issue here concerns whether the owner of a pharmaceutical patent may simultaneously assert a claim for infringement under § 271(e)(2), and a claim pursuant to the Declaratory...more

Do You Offer or Accept Copayment Coupons? OIG says YOU are Responsible for Compliance with Federal Law

In recent years, copayment coupon programs have become standard promotional practices for both large and small pharmaceutical manufacturers. Copayment coupons are typically offered to commercially insured patients in order...more

Depomed, Inc. v. Actavis Elizabeth LLC

Nature of the Case and Issue(s) Presented: Depomed sued Actavis for infringing seven patents related to a dosage form capable of being retained in the stomach, allowing for the delayed-release of gabapentin in the small...more

Fresenius Kabi USA, LLC v. Dr. Reddy’s Labs., Ltd.

Nature of the Case and Issue(s) Presented: Plaintiff filed suit alleging infringement of claims 1, 16, 36, and 37 of each of the patents-in-suit. The patents-in-suit all claim pharmaceutical compositions containing propofol...more

Doctors, Lawyers and the Controversial Prop 46

What's the most controversial measure on California's November ballot? The insurance regulation bill, Prop 45, may be a good contender – but more than likely the controversy over Proposition 46 will win the contest hands...more

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