Prescription Drugs

News & Analysis as of

Health Alert (Australia) - November 23, 2015

In This Issue: -Judgments; Legislation; and Reports -Excerpt from Judgments: Commonwealth. Federal Court - 17 November 2015 - Burnett v Eastern Health [2015] FCA 1247 The Federal Court of Australia...more

Congressional Hearing Examines Competition in the PBM Industry

Last week, pharmacy benefit manager (PBM) and independent pharmacy representatives provided testimony to the House Judiciary Subcommittee on Regulatory Reform, Commercial and Antitrust Law in a congressional hearing examining...more

ML Strategies Health Care Update – DNA Sequencing Workshop and Drug Pricing Developments

On Tuesday, ML Strategies (MLS) posted its weekly Health Care Update, which provides information from the previous week on a variety of important health-care-related topics....more

J & J Files Cert Petition in Massachusetts Supreme Court’s Unsupportable Rejection of Preemption Defense in Reckis TEN/Children’s...

Back in April, we blogged about the Massachusetts Supreme Court’s head-scratching rejection of defendants’ preemption defense in Reckis v. Johnson & Johnson, 471 Mass. 272, 2015 Mass. LEXIS 169 (Mass. April 17, 2015). As...more

Location of Accused Activity Informs Post-Approval Enforceability of “Quality-Control” Process Patents

On November 10, 2015, the United States Court of Appeals for the Federal Circuit issued its decision in two companion cases: Momenta Pharms. Inc. v. Teva Pharms. USA Inc. (14-CV-1274, 14-CV-1277) and Momenta Pharms. Inc. v....more

China FDA Announces Implementation Scheme to Improve the Drug Approval System

Following the reform of the drug and device approval system by China’s State Council in August,1 the China Food and Drug Administration (“CFDA”) has finally unveiled its implementation policies regarding improvements to the...more

Tidbits and Takeaways from OIG’s 2016 Work Plan

The Office of Inspector General for Health and Human Services (“OIG”) recently issued its 2016 Work Plan, which sets the agenda for its auditing and investigation in the year ahead. The broad mandate of the OIG is to...more

FDA Approval of Addyi Sparks Debate

Is the controversial new drug touted as female Viagra cause for celebration or concern? Does the little pink pill represent “girl” power, or is it a shortsighted remedy for sexual dysfunction in women? Do its benefits...more

MedPAC Met to Discuss Part B Drug Payment Policies and Other Issues

On November 5 and 6, 2015, MedPAC held its monthly meeting in Washington, D.C. to discuss Medicare issues and policy questions, develop and approve reports, and make recommendations to Congress. Among the topics discussed...more

Privacy Tip #9: Destroying prescription information

Have you ever noticed how much of your personal information is included on a prescription bottle and its packaging? Take a look next time you pick up a prescription at the pharmacy. The outer packaging may include your name,...more

OIG Policy Statement Outlines Conditions Under Which Hospitals May Waive Beneficiary Copayments for Outpatient Self-Administered...

The OIG has issued a policy statement clarifying the conditions under which hospitals may discount or waive Medicare beneficiary copayment amounts for self-administered drugs (SADs) received in outpatient settings without...more

Arrest of Pharma Executive on Federal Kickback Charges Sends Strong Message About DOJ's Initiative on Personal Accountability

Federal agents recently arrested the former president of an Allergan PLC division on charges of conspiring to pay kickbacks to physicians to induce them to prescribe the company's drugs. On October 28, 2015, a grand jury in...more

DOJ Backs Up Yates Memo with Indictment of Former Warner Chilcott Executive

A grand jury in the U.S. District Court for the District of Massachusetts returned an indictment against W. Carl Reichel, a former president of Warner Chilcott PLC's pharmaceuticals division, on Oct. 28, 2015. A day later, he...more

OIG Issues Guidance Related to Free and Discounted Prescription Drugs Provided to Patients

HHS Office of Inspector General (OIG) recently clarified its guidance related to the provision of free or discounted prescription drugs in two contexts: (1) hospital discounts or waivers of self-administered drugs in...more

New Preemption Decisions That We Can't Discuss Quite Yet

As lawyers, we have to get client approval before we can discuss their litigation substantively. Here are a couple just-in decisions where we’re doing that, but that are important enough our readers would want to know about...more

FTC Urges FDA to Rethink Its Biosimilar Naming Proposal; Other Stakeholders Agree

The Federal Trade Commission (FTC) last week disputed the effectiveness and competitive impact of the Food and Drug Administration’s recently proposed biosimilar naming policy and argued that using different nonproprietary...more

Prosecutors win rare murder conviction of M.D. in prescription drug deaths

The Centers for Disease Control and Prevention offers but one voice among many that has declared that the United States is in the midst of a prescription drug abuse epidemic. As the CDC notes: “Since 1999, the amount of...more

Novartis Pharm. Corp. v. Zydus Noveltech Inc.

Case Name: Novartis Pharm. Corp. v. Zydus Noveltech Inc., Civ. No. 14-cv-1104-RGA, 2015 U.S. Dist. LEXIS 103708 (D. Del. Aug. 7, 2015) (Andrews, J.) - Drug Product and Patent(s)-in-Suit: Exelon® (rivastigmine); U.S....more

Health Care Update - November 2015

Ways & Means Leadership Changes – Health Policy Implications Looming: As Congress pushes forward with a two-year budget deal, and new Speaker Paul Ryan begins his tenure as the top Republican in the House of...more

Blog: OIG Releases FY2016 Work Plan: Areas to be Reviewed Include SNFs, Drug Pricing, HIPAA

The Department of Health and Human Services (HHS) Office of Inspector General (OIG) released this week its FY2016 Work Plan (Work Plan). The OIG Work Plan summarizes new and ongoing OIG reviews of various HHS programs and...more

Endo Pharms. Inc. v. Amneal Pharms. LLC

Case Name: Endo Pharms. Inc. v. Amneal Pharms. LLC, Civ. Nos. 12 Civ. 8115 (TPG), 12 Civ. 8060 (TPG), 12 Civ. 8317 (TPG), 12 Civ. 8985 (TPG), 13 Civ. 435 (TPG), 13 Civ. 436 (TPG), 13 Civ. 3288 (TPG), 13 Civ. 4343 (TPG), 13...more

EEOC Sues Randstad for Disability Discrimination

Temporary Agency Refused to Hire Laborer Because She Was a Recovering Drug Addict in Medically Supervised Treatment Program, Federal Agency Charges - BALTIMORE - Baltimore-based temporary labor agency Randstad, US, LP,...more

Three Pressing Challenges for Personalized Medicine

Personalized medicine can be described as the science of targeted therapies. Advances in diagnostic and molecular medicine have made it possible to more precisely identify alternative treatment options for patients based on...more

Millennium Pharms., Inc. v. Sandoz Inc.

Case Name: Millennium Pharms., Inc. v. Sandoz Inc., Civ. No. 12-1011-GMS (consolidated), 2015 U.S. Dist. LEXIS 110099 (D. Del. Aug. 20, 2015) (Sleet, J.) - Drug Product and Patent(s)-in-Suit: Velcade® (bortezomib); U.S....more

MA Health Policy Updates – Moves to Strengthen HPC and Expand Telemedicine

In a recent Alert, the Mintz Levin Health Law Practice and ML Strategies provided a comprehensive look at recent developments in Massachusetts health policy. In addition to a detailed report on recent Health Policy Commission...more

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