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Stikeman Elliott LLP

The Pharmacare Act Receives Royal Assent

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On October 10, 2024, Canada’s Bill C-64, An Act respecting pharmacare (the “Pharmacare Act”) received Royal Assent. This legislation establishes a framework for a national universal pharmacare system, aiming to enhance the...more

Stikeman Elliott LLP

Regulatory Amendments Impacting Drug and Medical Device Recalls Coming Into Force

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On December 17, 2024, recent amendments to the Food and Drug Regulations (FDR) and the Medical Devices Regulations (MDR) relating to the recall of drugs and medical devices will come into force....more

Polsinelli

Florida Proposes New Pharmacy Benefit Manager Rules

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On September 18, 2023, the Florida Office of Insurance Regulation (“OIR”) published proposed rules to implement provisions of the Prescription Drug Reform Act (Florida Senate Bill 1550) governing Pharmacy Benefit Managers...more

Akerman LLP

Florida's Prescription Drug Reform Act: What's in it for Florida Pharmacies?

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The Florida legislature took aim at pharmacy benefit managers (PBMs) during the 2023 legislative session by enacting the Prescription Drug Reform Act, Chapter 2023-29, Laws of Florida (https://laws.flrules.org/2023/29) (the...more

McDermott+

McDermottPlus Check-Up: May 19, 2023

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The House and Senate were both in session this week, with significant healthcare activity at the committee level. The House Ways & Means Committee met to discuss healthcare price transparency, and the Ways & Means Health...more

Manatt, Phelps & Phillips, LLP

[Webinar] Implications Across the Health Care System of the New Federal Drug Price Regulation - September 22nd, 1:00 pm - 2:00 pm...

The Inflation Reduction Act of 2022 (IRA) includes the most dramatic change to U.S. drug price regulation in history. The new law allows the federal government to “negotiate” the price of many drugs dispensed to Medicare...more

American Conference Institute (ACI)

[Event] Controlled Substances – Regulation, Litigation, and Enforcement - July 12th - 13th, Washington, DC

The only conference that presents strategies and solutions for every link of the controlled substances supply chain. Attend and learn how to best conform business practices to meet industry and regulatory demands, bolster...more

Smart & Biggar

Special Access Program and Emergency Drug Release Program amendments in force

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On September 28, 2020, the Regulations Amending Certain Regulations Made under the Food and Drugs Act (Sale of a New Drug for Emergency Treatment) (Regulations) came into force. Health Canada subsequently published a Notice,...more

Mintz - Health Care Viewpoints

Final Canadian Drug Importation Rule and HHS Certification Issued Under Section 804 of the Food, Drug and Cosmetic Act

As previously covered on this blog, in mid-2019 the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) jointly published the Safe Importation Action Plan, which outlined the Trump...more

King & Spalding

EPA Issues New Waste Rules for Hospitals, Medical Clinics and Pharmacies

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The U.S. Environmental Protection Agency (“EPA”) recently issued new regulations for managing pharmaceutical waste under the Resource Conservation and Recovery Act (“RCRA”). The rules specify new requirements for hazardous...more

Bricker Graydon LLP

Federal appeals court rules against the American Hospital Association’s challenge to the $1.6 billion in Medicare 340B cuts

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On July 17, 2017, the U.S. Court of Appeals for the District of Columbia Circuit ruled in favor of the Department of Health and Human Services (HHS), finding that the American Hospital Association’s (AHA) legal challenge of...more

Smart & Biggar

Rx IP Update - May 2018

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An Update on Vanessa’s Law - This is a special update on the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) which was approved on November 6, 2014 (as previously reported), amending the Food and Drugs Act...more

Goodwin

Wisconsin and West Virginia Pass Biosimilar Legislation

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Last week, both Wisconsin and West Virginia passed legislation intended to facilitate the dispensing and substitution of biosimilar products. Wisconsin and West Virginia join Michigan, which enacted House Bill 4472 on...more

Goodwin

South Dakota Passes Automatic Substitution Law for Interchangeable Biosimilars

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South Dakota passed a law that allows pharmacists to automatically substitute a biosimilar for a prescribed biological product. According to the new law, which was signed by South Dakota’s governor on February 12, 2018, the...more

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

Uncle Sam should be wary in partnering with Big Pharma on cancer treatments

Is Uncle Sam launching a way to speed and improve cancer treatments so they get to patients sooner—or is Big Pharma about to fleece taxpayers, yet again? The National Institutes of Health should carefully consider its just...more

Goodwin

Nebraska Enacts Law To Allow Automatic Substitution Of Interchangeable Biosimilars

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As we previously reported, the Nebraska legislature had been considering a bill that would allow automatic substitution of “interchangeable” biosimilar products where a physician prescribes a biologic product. Last month, the...more

Goodwin

New Mexico Senate Passes Bill Allowing Automatic Substitution of Interchangeable Biologics

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Last week, the New Mexico Senate passed a bill that would amend New Mexico’s existing automatic substitution law for small molecule drugs to allow “a pharmacist to dispense any one of the … interchangeable biological products...more

Morgan Lewis

HRSA Publishes Orphan Drug Rule for 340B Program

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Rule requires most manufacturers to change government pricing methodologies, calculations, and systems. On July 23, the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human...more

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