Prescription Drugs

News & Analysis as of

EEOC Sues Physicians Management Groups For Disability Discrimination

Doctor's Contract Terminated for Taking Prescribed Medications, Federal Agency Charged - ATLANTA - Two Atlanta physicians groups, Georgia Hospitalists Group, LLC and ApolloMD Business Services, LLC, violated federal law...more

Third Circuit Creates Framework for Analyzing Numerosity

The Third Circuit recently vacated class certification, granted by the Eastern District of Pennsylvania after nearly a decade of litigation, in an antitrust case alleging that a pharmaceutical company entered into agreements...more

Worth Another Look: Joint Session on Opioid Addiction

“But in Pennsylvania, the problem is visible—in the lives lost. The families broken. The communities shaken.” – Gov. Tom Wolf to a Joint Session of the General Assembly, September 28, 2016. Gov. Tom Wolf addressed a...more

Viagra — Developments in Litigation

There have been some very recent developments in the national litigation regarding the erectile dysfunction (ED) drug Viagra and the allegation that its use increases a patient’s risk of developing melanoma. Judge Seeborg,...more

Health Alert (Australia) 26 September 2016

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: Queensland - 10 September 2016 - Inquest into the death of C - C was a 14 year old girl with multiple physical and...more

FDA Holding its First Public Meeting on Drug Product Identification Requirements in October

Last week FDA published a notice of public meeting and a request for comments regarding certain aspects of the Drug Supply Chain Security Act (DSCSA). The meeting will take place on October 14, 2016 at the Agency’s campus in...more

Ugly details emerge on how Big Pharma fueled painkiller scourge

New information has surfaced about Big Pharma’s relentless campaign to sell the public on prescription, opioid painkillers-powerful, addictive drugs whose wide availability and abuse now has become a killer scourge that...more

Aralez’s YOSPRALA wins FDA approval

On September 15, 2016, the U.S. Food and Drug Administration approved once-daily YOSPRALA™, a tablet that combines the anti-platelet agent, aspirin, with the anti-acid drug, omeprazole for decreasing the risk of...more

SDNY Awards Front Pay in Sarbanes-Oxley Whistleblower Retaliation Case

Perez v. Progenics Pharmaceuticals, Inc., involved a case where Plaintiff Perez drafted a memo to Progenics’ general counsel and his department head, accusing Progenics of committing fraud by publishing a false press release...more

The EpiPen Controversy Signals Intensifying Scrutiny of Drug Classification Under Medicaid Rebate Program

Price increases threatening the availability of EpiPen® and EpiPen Jr® Auto-Injectors (“EpiPen”) have touched off the latest firestorm over drug pricing. Lost amid the public outcry, however, is a thorny regulatory issue:...more

Medicare Plan Finder to Indicate which MA, Part D Plans Have Been Sanctioned

CMS revealed last week that Medicare Plan Finder soon will note for users whether a Medicare Advantage plan or Part D prescription drug plan has been sanctioned. The Medicare Plan Finder is an online tool that allows...more

Third Circuit Decertifies Class on Numerosity Grounds, Listing Relevant Factors for the First Time

The Modafinil decision bodes well for defendants and represents another step toward increased scrutiny of the class action device in the Third Circuit. On September 13, a divided panel of the U.S. Court of Appeals for...more

EEOC Sues Owners of Happy Jack’s Casino For Disability Discrimination

Federal Agency Says Owners Rejected Applicant Because She Took Prescription Drugs For Her Medical Condition - SIOUX FALLS, S.D. - M.G. Oil Company, which operates Happy Jack's Casino in Sioux Falls, South Dakota,...more

Manatt on Health Reform: Weekly Highlights - September 2016 #2

CMS denies Ohio’s Medicaid 1115 waiver request citing the State’s premium proposal; HHS will use 2015 risk corridors collections for remaining 2014 payments; and Alabama closes its Medicaid budget shortfall....more

CIMZIA Does Not Infringe Yeda’s Monoclonal Antibody Patent

In UCB, Inc. v. Yeda Research and Development Co., the Federal Circuit affirmed the determination by the District Court for the Eastern District of Virginia that UCB, Inc.’s Cimzia® (certolizumab pegol), a biologic medicine...more

Express Scripts Announces New Program for Biologics

On Thursday, September 8, Express Scripts introduced its Inflammatory Conditions Care Value Program, which it says is a “comprehensive approach to control costs and improve care for people with inflammatory conditions like...more

Patients inflamed by another drug cost hike and middleman’s effort to curb it

The public furor with Big Pharma’s relentless skyward ratcheting of drug prices may be focusing soon on another set of medications, this time powerful anti-inflammatories, and the rising role played by middlemen in the...more

2018 Notice of Benefits and Payment: Proposed Updates to the HHS Risk Adjustment Model

Last week, the Centers for Medicare & Medicaid Services (“CMS”) released its 2018 Notice of Benefit and Payment setting out payment parameters for the Health Insurance Marketplace for upcoming years. With several insurers...more

OIG Work Plan: A Roadmap to Identify Health Care Compliance Risk

Each year, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) issues a Work Plan that summarizes new and ongoing OIG reviews and areas of focused attention for the coming year and beyond....more

California Ballot 2016: Pros and Cons of Props 57-61

This is the second post in our California Ballot 2016 series – providing the “nutshell” versions of each of the 17 state-wide measures voters must decide in November. Please refer to our first post in the series: Props 51-56,...more

FDA Announces Dates for Long-Awaited Public Hearing on Its Regulation of Off-Label Communications

Times, They Are A-Changin’ - On Wednesday, FDA announced that it will hold a two-day public hearing on November 9th and 10th to obtain input from a broad cross-section of the health care industry, including...more

Your daily dose of financial news - The Brief - 9.2.16

Turns out that the Anbang Insurance Group—the powerful Chinese insurer that’s made plenty of Brief appearances for its massive bids on US hotels, among others—really does live up to its air of mystery, with many of its...more

Compounding Pharmacy’s Group Boycott Claim Survives Motion to Dismiss

On August 23, 2016, the District Court for the Eastern District of Missouri allowed claims by a compounding pharmacy to proceed, denying a motion to dismiss filed by the defendant pharmacy benefit manager (“PBM”). In...more

Manatt on Health Reform: Weekly Highlights - August 2016 #5

A federal report finds that Marketplace premiums are lower in expansion states; Massachusetts and Pennsylvania launch prescription drug monitoring systems; and Kentucky submits a slightly modified Medicaid expansion waiver to...more

Drug Costs Study Argues for Increased Funding for Biosimilar Review

A recent meta-analysis investigated several factors impacting prescription drug costs in the United States. Doctors associated with the Brigham and Women’s Hospital and Harvard Medical School authored the report. Funding...more

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