Prescription Drugs

News & Analysis as of

A One-Two Punch Case With An Off-Label Twist

When we were young(er), we had a pretty good memory. It is not bad now, as far as we recall, particularly when it comes to pulling up bits of esoteric nonsense. For more important stuff, we find qualifiers like “vague” and...more

Worth Another Look: Combatting Opioid Addiction

In January of 2016, the National Conference of State Legislatures (NCSL) published a list of the top 10 issues that will be before state legislatures across the nation this year. With little expected on the legislative front...more

Is There Coverage for The Pill Mill Lawsuits?

In an effort to deal with the terrible epidemic of drug abuse and the human and economic costs of this dilemma, the state of West Virginia has brought lawsuits in several jurisdictions against pharmaceutical companies and...more

Manatt on Health Reform: Weekly Highlights - July 2016 #3

Massachusetts’s Marketplace eliminates cost-sharing for addiction treatment in subsidized QHPs; Montana cuts its uninsurance rate in half; and a Kaiser report identifies the 50 most costly drugs for Medicaid....more

Legal Update: Amendments to the Public School Code - Diabetes Management

On July 13, 2016, Governor Wolf signed into law House Bill 1606, now known as Act 86 of 2016 (“Act 86”). Included among the numerous amendments to the Public School Code, Act 86 establishes new requirements for LEAs related...more

Obama Administration, Congress Take Steps to Fight Opioid Epidemic

HHS has announced a series of actions to address the nation’s opioid epidemic, as Congress has cleared the Comprehensive Addiction and Recovery Act for the President’s signature. As part of the HHS activities, the Substance...more

CMS Guidance Addresses Impact of Value-Based Purchasing on Medicaid Drug Rebates

CMS has received questions from manufacturers regarding whether price concessions and services offered to payers within Value-Based Purchasing (VBP) arrangements in the pharmaceutical marketplace could impact their drug’s...more

Something Went Right In Brazil

Zika virus, Olympic unpreparedness, economic collapse, presidential impeachment - a lot of things have gone wrong in Brazil lately. But we’re not here to talk about any of that. Here’s something that went right: Brazil v....more

OIG Permits Copayment Coupon Arrangement for Statutorily Non-Covered Drug in Advisory Opinion 16-07

On June 20, 2016, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued a favorable Advisory Opinion 16-07 regarding a savings card program (Card Program) under which Medicare Part D...more

Addressing the Opioid Crisis

Following the July 13 U.S. Senate's passage of Comprehensive Addiction and Recovery Act (CARA), providers, families and communities should evaluate the act's impacts. The reform, S. 524, is viewed as a comprehensive approach...more

FDA Reorganization Takes on Cancer Moonshot and Other Initiatives

On July 11, 1969, the United States accomplished the almost unthinkable –two men walking on the moon. Conjuring images of that moon landing, President Obama moved forward the “Cancer Moonshot” program at his January 2016...more

Another Off-Label Promotion Third Party Payor Case Lacks Causation

July in D.C. is hot and sticky. When scorching day follows scorching day, area residents look forward to evening thunderstorms, not just to water otherwise thirsty lawns and gardens but to cool things down. Lightning can be...more

Teaming Up to Cure Cancer "Patents 4 Patients" – Fast Track Review

The United States Patent and Trademark Office “USPTO” is launching the “Patents 4 Patients” initiative, which will provide an accelerated review for methods of cancer treatments. Effective on June 29, 2016 the new “Cancer...more

Missouri Governor Signs Biosimilar Substitution Law

Last month, Missouri Governor Jay Nixon signed into law Senate Bill 875, allowing pharmacists filling prescriptions for brand name biological products to substitute a less expensive biosimilar product if the biosimilar has...more

Additional Opioid Policy Changes Announced: What You Need to Know

Despite the July 4 holiday, the past week featured significant regulatory and legislative action addressing the use of opioids and pain management. The changes are in keeping with the Government-wide push to better understand...more

En Banc: Federal Circuit Provides Guidance on Application of On-Sale Bar to Contract Manufacturers

Pharmaceutical and biotech companies breathed a sigh of relief Monday when the Federal Circuit unanimously ruled in a precedential opinion that the mere sale of manufacturing services to create embodiments of a patented...more

Federal Circuit Finds That Use of a Contract Manufacturer Does Not Trigger the On-Sale Bar Provision

The court’s decision provides insight into which activities trigger the on-sale bar provision. On July 11, in The Medicines Co. v. Hospira, Inc., No. 14-1469 (Fed. Cir. July 11, 2016), the U.S. Court of Appeals for the...more

Federal Circuit Limits On-Sale Bar’s Reach

If you were concerned that outsourcing the manufacture of your invention before you filed your patent application triggered a "sale" that could put your patent at risk, you can rest easy. In The Medicines Company v....more

FDA Advisory Panels Considering Approvals of Two Biosimilars This Week

An FDA advisory panel unanimously voted to recommend approval of Amgen’s ABP501 biosimilar of AbbVie’s Humira (adalimumab) on July 12, 2016. Likewise, an FDA advisory panel is scheduled to consider approval of Sandoz’s...more

Women’s Health Litigation Conference

No television show gives its viewers more than Game of Thrones – more characters, more plot-lines, more sex, more violence, and more magic. The enormous production values scream from the screen. The frame cannot quite...more

Dual Tracks Taken by FDA in Approving Products by ‘Big Pharma’

Prescription drugs exist to boost the health of patients by decreasing their pain, increasing their stamina, staving off infections and treating their symptoms. The U.S. Food and Drug Administration has the responsibility to...more

FDA: Amgen’s Biosimilar “Highly Similar” to Abbvie’s Humira

A preliminary review by FDA staff found that Amgen Inc.’s biosimilar of AbbVie Inc.’s Humira® showed potency and safety similar to the original product. Humira® (adalimumab) is the top-selling drug in the world and is used to...more

Third Party Administrator Update: TPA Regulatory and Legislative Developments

Polsinelli is pleased to share the June 2016 Third Party Administrator Newsletter. This newsletter covers topics throughout the year that impact TPAs. Information specific to Polsinelli's TPA practice is also included....more

Middle District of Louisiana Gets it Wrong: A Different Product is not an “Alternative Design”

Over the Fourth of July weekend, we in the Philadelphia area learned that 120 of the “new, state-of-the-art” trains in our regional commuter rail system were being pulled out of service. Someone noticed that the trains were...more

Deal Watch: AstraZeneca and LEO Pharma collaborate on skin drugs tralokinumab and brodalumab

AstraZeneca announced today that it has entered licensing agreements with LEO Pharma to develop and commercialize tralokinumab, a biologic that has completed a Phase IIb trial for atopic dermatitis, and brodalumab, which is...more

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