Prescription Drugs

News & Analysis as of

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

Front End Changes and, Again, More DIR Columns

Since the beginning of the Medicare Part D program, CMS has introduced many reporting mechanisms for trying to understand drug pricing, price concessions, and the cost of providing services to Part D members. The tool CMS...more

Hospira, Inc. v. Burwell

Nature of the Case and Issue(s) Presented: Precedex is commonly used as a sedative. Specifically, the FDA has approved Precedex for two uses: (i) sedation of initially intubated and mechanically ventilated patients during...more

Apotex Inc. v. UCB, Inc.

Nature of the Case and Issue(s) Presented: Apotex appealed the district court’s finding that the ’556 patent was unenforceable due to inequitable conduct. The ’556 patent describes a method for making moexipril tablets used...more

Mintz Levin Health Care Qui Tam Update - Recent Developments & Unsealed False Claims Act Cases: October 2014

Trends & Analysis - Between our last Qui Tam Update and the end of June, 65 health care–related qui tam cases were unsealed (28 in April, 18 in May, and 19 in June). Within those 65 cases...more

Ferring B.V. v. Watson Labs., Inc.—Florida (I)

Nature of the Case and Issue(s) Presented: The issue of infringement in this case relates entirely to dissolution rates. Apotex sought to market its generic product by designing around Ferring’s Lysteda. In its 2010 ANDA,...more

A Possible Green Light for Patient Transportation Services: OIG Proposes Revised Safe Harbors to the Anti-Kickback Statute for...

On October 3, 2014, the Office of Inspector General of the Department of Health and Human Services (“OIG”) published a proposed rule and request for comments (“Proposed Rule”), which would amend the Anti-Kickback Statute...more

Phrma Challenges HRSA Interpretative Rule On Orphan Drugs In The 340B Drug Discount Program

On October 9, 2014, the Pharmaceutical Research & Manufacturers of America (“PhRMA”) filed a lawsuit seeking to enjoin the Health Resources Services Administration (“HRSA”) from implementing its July 23, 2014 “Interpretive...more

Ninth Circuit: City's Pioneering Drug-Disposal Ordinance Does Not Violate Commerce Clause

If your medicine cabinet is filled with old prescriptions and other medications that you no longer want or can use, you might have asked: how and where should I get rid of these? Local governments are beginning to...more

Federal and New York State False Claims Act Case Against Novartis Survives Motion to Dismiss

Last week, a New York district court found that the government alleged with sufficient detail that Novartis violated federal and state false claims acts by paying doctors kickbacks to prescribe drugs. See U.S. ex rel. Bilotta...more

Canadian Competition Bureau chief takes a tough stance on pay-to-delay agreements

The Canadian Competition Bureau intends to take a tough approach to so-called “pay-to-delay” settlements, potentially anti-competitive agreements in which generic drug manufacturers agree to delay the launch of a low-cost...more

U.S. Supreme Court Upholds Fourth Circuit Victory for Omnicare, Inc. in High-profile, Precedent-setting False Claims Act Case

On October 6, 2014, the U.S. Supreme Court denied review of a groundbreaking Fourth Circuit decision affirming the dismissal of a novel False Claims Act suit against Reed Smith client Omnicare, Inc. In its February 2014...more

FDA Regulatory and Compliance Monthly Recap - September 2014

In This Issue: - FDA sends warning letters to companies that made claims on social media that their products treat, cure Ebola, marking the first time the agency singles out Pinterest - OIG issues special...more

Curtailing Access to Combat Abuse - New DEA Regulations Focus on Prescription Medication Collection

The Drug Enforcement Administration’s (DEA) new regulations aimed to cut down on prescription drug abuse will soon allow patients to return unused pharmaceuticals to authorized locations. The new rules go into effect October...more

OIG Offers Greater Protections for Health Care Providers in New Proposed Rule

On October 3, 2014, the U.S. Department of Health and Human Services of the Office of Inspector General (OIG) issued a Proposed Rule amending both the safe harbors to the anti-kickback statute and the civil monetary penalty...more

OIG Warns Pharmaceutical Manufacturers of Improper Part D Beneficiary Coupon Use

On September 19, 2014, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) released a study showing that pharmaceutical manufacturer safeguards to prevent Medicare Part D (“Part D”)...more

Will Namenda IR Withdrawal Force A Legal Switch on Product Hopping?

On September 15, 2014, New York Attorney General Eric Schneiderman filed an anti-trust lawsuit against the specialty pharmaceutical company Forest Laboratories and its new owner, Actavis. In the suit, Schneiderman alleges the...more

Ninth Circuit Upholds Alameda Safe Drug Disposal Ordinance, Triggering Implementation of King County Secure Medicine Return Rule

On September 30, 2014, the Ninth Circuit affirmed the Northern District of California’s summary judgment that the Alameda Safe Drug Disposal Ordinance (the “Ordinance”) does not violate the dormant Commerce Clause of the...more

Court Rejects Workers Comp Insurer’s Challenge to Big Pharma

Pharmaceutical manufacturers that promote off-label uses for prescription drugs have become litigation targets for third-party payors—especially after Kaiser received a nine-figure RICO award last year against the...more

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