Prescription Drugs

News & Analysis as of

Latest Spike in Prescription Drug Spending Prompts OIG Investigation

A new report released by the IMS Institute for Healthcare Informatics shows that U.S. spending on pharmaceuticals increased in 2014 by 13.1 percent, reaching $373.9 billion. This is the highest increase since 2001 when drug...more

Following FDA’s First Biosimilar License, CMS Issues Guidance on Reimbursement for Biosimilars

On March 6, 2015, FDA released a statement announcing its issuance of the first biosimilar license to Zarxio. In the same month, CMS issued a number of guidance documents addressing reimbursement for biosimilars under the...more

CMS Announces Key 2015 Compliance Priorities for Federally Facilitated Exchange Plans

The Centers for Medicare & Medicaid Services (“CMS”) recently announced its 2015 key priorities for compliance reviews of qualified health plans (“QHPs”) offered in the federally facilitated marketplaces (“FFMs”). Through a...more

CMS Fines Insurer for Misleading Medicare Part D Beneficiaries

The federal agency that oversees Medicare’s prescription drug program has alleged that a major U.S. insurance company misled beneficiaries about the pharmacies included in the company’s drug plan, and imposed a $1 million...more

OMB Reviewing HRSA Proposed Rule For Civil Monetary Penalties And Ceiling Price Regulations For 340B Drug Discount Program

The agency that oversees the 340B Drug Discount Program (340B program) is seeking review by the White House Office of Management and Budget (OMB) of a proposed rule that would use civil monetary penalties to enforce ceiling...more

Health Alert (Australia) - April 20, 2015

In This Issue: Judgments; Legislation; and Reports. Excerpt from Judgments: New South Wales (NSW) - 13 April 2015 - Sarah White v The Local Health Authority & Anor - [2015] NSWC 417 - The New South...more

Telemedicine Providers Need to Keep Up with State Laws

Tech-savvy health care providers and tech-savvy patients in California can be grateful for California’s policies regarding telehealth practices. Consider the turmoil in Texas: telehealth practitioners who want to treat...more

Some Plaintiffs Just Have No Class

We’ve been thinking a lot about class actions lately. One reason is that the Rule 23 Subcommittee of the (federal) Advisory Committee on Civil Rules just came out with a “sketch” of possible amendments – and from the defense...more

What are the 2 leading causes of medication errors?

Every individual reacts to medication differently, as many a medical malpractice lawyer in Illinois knows. Discovering the appropriate drug and dosage for any given health issue is a process that requires careful attention by...more

Stricter Standing for Inter Partes Review?

Neither the statutes nor the regulations governing Inter Partes Review (IPR) require the party challenging the patent to have been charged with infringement, or even to establish any interest in practicing the claimed subject...more

Washington Healthcare Update

This Week: Montana Legislature Reverses Course, Endorses Medicaid Expansion... Final 2016 Medicare Advantage and Part D Rate Announcement and Call Letter... Upcoming: Energy and Commerce Subcommittee Hearing on Post-Acute...more

Dazed and Confused: The TCPA’s Health Care-Related Call Exemption

In early 2012, Robert Kolinek received an automated call on his cell phone from Walgreens reminding him to refill an eligible prescription. Despite the fact that even the plaintiff’s lawyers ultimately acknowledged that these...more

What Oklahoma's amended Uniform Controlled Dangerous Substances Act means for prescribing medical providers

Last Friday, Oklahoma Governor Fallin signed House Bill 1948 into law, amending the Uniform Controlled Dangerous Substances Act. The new law, which goes into effect on November 1, 2015, enhances access to Oklahoma’s...more

Court Declines to Certify Class Alleging Off-Label Marketing of Cancer Drug

Third party payors (“TPPs”) responsible for paying the costs of prescriptions for their beneficiaries sued Cephalon, Inc., alleging that it engaged in unlawful off-label marketing of Actiq, a drug approved to manage...more

FDA Regulatory and Compliance Monthly Recap – March 2015

In This Issue: - FDA issues guidance on meetings between agency and sponsors to promote consistency and effectiveness - FDA approves Novartis’ Zarxio as the first biosimilar in the U.S., clearing the drug for...more

District Court Holds Individual Issues of Fact Predominate in Unjust Enrichment Class Action

The US District Court for the Eastern District of Pennsylvania recently denied class certification to a proposed class of third-party payors of prescription drugs. The plaintiffs brought a class action for unjust enrichment,...more

Product Liability Update - April 2015

In This Issue: - First Circuit Holds State Law Claims Against Drug Manufacturer for Allegedly Misleading Efficacy Representations in FDA-Approved Label Preempted by Food, Drug & Cosmetic Act Because Plaintiffs’...more

HRSA Moving Ahead on 340B Program Enforcement Rule, Including Manufacturer CMPs for Overcharges to 340B Entities

The Health Resources and Services Administration (HRSA) is seeking White House review of its proposed rule to implement new Affordable Care Act 340B drug discount program enforcement authorities and pricing policies. More...more

Congress Holds Hearing on 340B Program

The U.S. House of Representatives Committee on Energy and Commerce, Subcommittee on Health held a hearing on March 24, 2015 to review the functionality of the 340B Drug Pricing Program to understand how it impacts patients,...more

Breaking News – Post-2002 NJ Accutane Labels Adequate As A Matter Of Law

This just in – after many years of litigation, the post April 10, 2002 warnings on Accutane were determined to be adequate as a matter of law by the New Jersey judge tasked with overseeing this mass tort....more

Walgreen Settles Prescription Robocall Suit for $11 million

Walgreen Co. this week settled a putative class action law suit alleging that it violated the Telephone Consumer Protection Act (TCPA) for $11 million. The plaintiffs alleged that Walgreen violated TCPA when it placed...more

Important Recommendations from the MedPAC March Report to Congress, Part One

Each March, the Medicare Payment Advisory Commission (“MedPAC” or the “Commission”) is tasked with reporting to Congress on the current state of the Medicare fee-for-service (“FFS”) payment systems, the Medicare Advantage...more

Result-Driven Affirmance of Birth Defect Verdict

We have said it before – birth defect cases are hard. Juries and judges are sympathetic where the individual whose health is at issue had no say in the matter. We have also said that we do not like it when judges frame the...more

Health Alert (Australia) - March 30, 2015

In This Issue: Judgments; Legislation; and Reports. Excerpt from Judgments: New South Wales - 25 March 2015 - Smythe v Burgman (No 2) [2015] NSWSC 150 - The New South Wales Supreme Court has held...more

Brick By Brick, The Learned Intermediary Doctrine Paves A West Virginia Path

Back in November, we exulted over the pelvic mesh MDL judge’s resurrection of West Virginia’s learned intermediary doctrine. In Tyree v. Boston Scientific Corp., ___ F. Supp.3d ___, 2014 WL 5431993 (S.D.W. Va. Oct. 23,...more

637 Results
|
View per page
Page: of 26

All the intelligence you need, in one easy email:

Great! Your first step to building an email digest of JD Supra authors and topics. Log in with LinkedIn so we can start sending your digest...

Sign up for your custom alerts now, using LinkedIn ›

* 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.
×