News & Analysis as of

Prescription Drugs Generic Drugs Pharmacies

Hendershot Cowart P.C.

GLP-1 Shortage Ended: Can You Still Legally Prescribe or Compound Semaglutide and Tirzepatide?

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For the past several years, physicians and compounding pharmacies have stepped in to address critical patient access gaps during U.S. Food and Drug Administration (FDA) shortage declarations for semaglutide (Ozempic, Wegovy)...more

Tarter Krinsky & Drogin LLP

The Federal Trade Commission Launches Investigation into Pharmacy Benefit Managers

The Federal Trade Commission (FTC) has launched an inquiry into the largest Pharmacy Benefit Managers (PBMs) in the United States, with the goal of scrutinizing the PBMs’ practices and influence on the pharmaceutical...more

Pullman & Comley - Connecticut Health Law

Post-Public Health Emergency – Connecticut Pharmacy Limitation Changes

Connecticut has recently notified pharmacies and prescribing providers that various quantity limits and refill criteria will revert back to pre-COVID 19 requirements come May 21, 2021. The reinstatement of pre-COVID 19...more

Bricker Graydon LLP

“We’ll see you in court:” State expands lawsuit against pharmacy benefit manager in BWC contract dispute over generic drug prices

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After months of unsuccessful mediation, Ohio Attorney General Dave Yost filed an amended complaint in the Franklin County Court of Common Pleas against pharmacy benefit manager (PBM), OptumRx. The complaint, which brings...more

BakerHostetler

FDA and Pharmacy Weekly Digest - June 2019 #4

BakerHostetler on

Food/Dietary Supplements - FDA Announces Guidance on Added Sugar Labeling – The FDA published a new guidance for labeling of added sugars. ...more

Smart & Biggar

Rx IP Update - February 2019

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Orders of prohibition relating to polymorphic form patent for PRISTIQ upheld on appeal - As previously reported, the Federal Court, in a pair of decisions, granted orders prohibiting Apotex and Teva from marketing their...more

Patrick Malone & Associates P.C. | DC Injury...

Price-fixing scandal ensnares ‘white-hat’ makers of lower-cost generic drugs

To paraphrase what a one-time colleague once wrote about her bosses: Never trust Big Pharma, never trust Big Pharma, never trust Big Pharma. Here’s some of the latest evidence why: Even the industry’s so-called “white hats,”...more

Farrell Fritz, P.C.

Pharmaceutical Reforms in 2018-19 New York State Budget

Farrell Fritz, P.C. on

Notwithstanding the enactment of a first-in-the-nation drug spending cap last year, in light of the $4.4 billion deficit and ongoing concerns about the opioid crisis it was inevitable that this year New York State would once...more

Patrick Malone & Associates P.C. | DC Injury...

Sick of woes with Big Pharma, hospitals moving to make own generic drugs

Some big hospitals and hospital chains are on the brink of expanding into another aspect of health care. Let’s give them a rare cheer, because they’re taking on Big Pharma and its skyrocketing drug prices and too frequent...more

Epstein Becker & Green

Comment Deadline Approaches for CMS’s Proposed Changes to Medicare Advantage and Part D Programs for CY 2019 – Part 2: Beneficiary...

On November 28, 2017, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule titled “Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan,...more

Hogan Lovells

CMS Releases Major MA/Part D Proposed Rule

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CMS released the first major MA/Part D rulemaking in several years, proposing a number of significant changes to the Part D program, including required pass-through of pharmaceutical company rebates to lower patient...more

Mintz - ML Strategies

Transparency in Drug Pricing: Issues to Consider from the Research Lab to the Consumer

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Since 2014, drug pricing has grown in importance in health care policy conversations. From Gilead Sciences’s Hepatitis C treatment costing $84,000 per course of treatment to Turing Pharmaceutical’s 5,000 percent price hike of...more

King & Spalding

Also In The News - Health Headlines - January 2016 #3

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CMS Finalizes Medicaid Prescription Drug Rule – On January 21, 2016, CMS finalized a rule detailing reforms to the rebate and reimbursement systems for Medicaid prescription drugs, which the agency estimates “will save...more

King & Spalding

Final ACA Medicaid Drug Pricing Rule Published: Changes to 5i, Bundling, RCP and Other Provisions Leave a Lot for Manufacturers to...

King & Spalding on

On Thursday, January 21, the Centers for Medicare & Medicaid Services (CMS or “the Agency”) published its long-awaited final rule with comment period implementing the Medicaid pricing and reimbursement provisions of the...more

Mintz - Health Care Viewpoints

California Becomes Latest State to Pass Biosimilar Substitution Law

On October 6th, California’s governor signed Senate Bill 671, which permits pharmacists to substitute an interchangeable biological product for a prescribed biological product. The California legislature had attempted to pass...more

Robinson & Cole LLP

KMART Settles False Claims Act Allegations for $1.4 Million

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The U.S. Department of Justice (DOJ) recently announced that KMART Corp. (Kmart) has paid $1.4 million to settle a qui tam lawsuit brought by a former Kmart pharmacist under the False Claims Act (FCA). The lawsuit alleged...more

Ballard Spahr LLP

EPA Proposes New Rules for Pharmaceutical Hazardous Waste Management and for Other Hazardous Waste Generators

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The U.S. Environmental Protection Agency (EPA) has announced two new proposed hazardous waste rules that EPA believes would clarify and simplify requirements for health care facilities and retail pharmacies to manage their...more

K&L Gates LLP

Makena Drug Compounding Lawsuit Against FDA Gets New Life

K&L Gates LLP on

On January 7, 2014, a three-judge panel of the United States Circuit Court for the District of Columbia unanimously vacated the dismissal of claims against the U.S. Food and Drug Administration (“FDA”) and others by K-V...more

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