News & Analysis as of

Federal Funding Prescription Drugs Pharmaceutical Industry

Quarles & Brady LLP

Accessing Opioid Settlement Funds

Quarles & Brady LLP on

While federal funding for addiction treatment programs and research is being cut, more than $50 billion is being distributed to state and local programs from opioid-related lawsuits. There is great debate on the use of these...more

Proskauer - Health Care Law Brief

DOJ Targets Gender‑Affirming Care under FDCA and FCA: Scrutinizes Off‑Label Drug Use and False Diagnosis Codes

Last month, the United States Department of Justice (“DOJ”) issued its “Civil Division Enforcement Priorities” memorandum, memorializing a shift from its predecessor administration’s policy on gender‑affirming healthcare...more

Smart & Biggar

Government of Canada announces first pharmacare agreements

Smart & Biggar on

Update: The Government of Canada announced an agreement with the Yukon ($9.5 million over four years). The agreement text is available in the updated National pharmacare bilateral agreements resource....more

Stikeman Elliott LLP

Canada and Manitoba Sign Pharmacare Agreement Under New Pharmacare Act

Stikeman Elliott LLP on

Canada’s Bill C-64, An Act respecting pharmacare (the “Pharmacare Act”) received royal assent on October 10, 2024 and established a framework for national pharmacare. On February 27, 2025, the Hon. Mark Holland, Canada’s...more

Smart & Biggar

Minister of Health announces new bilateral agreements with provinces for rare disease drugs

Smart & Biggar on

We previously reported on Canada’s first-ever National Strategy for Drugs for Rare Diseases, which included up to $1.4 billion in funding for provinces and territories, to be negotiated through bilateral agreements. This...more

Alston & Bird

Health Care Week in Review: House Passes Minibus, HHS Releases Public Inquiry on Private Equity in Health Care

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Goodwin

Recent Bayh-Dole Act News: Comments on the Draft Framework; HHS Refuses to March-In on Xtandi; and Delayed Contracting Doesn’t...

Goodwin on

U.S. universities and academic institutions rely heavily on federal grants to fund their research and generate innovations in life sciences. Universities often out-license patents protecting inventions created using federal...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

IP Hot Topic: Biden Administration Proposes Framework for Exercising Bayh-Dole March-in Rights to Control Drug Pricing

The Biden-Harris Administration recently announced various actions to lower healthcare and prescription drug costs. In one action, the National Institute of Standards and Technology (NIST) released in December 2023 a draft...more

Morrison & Foerster LLP - Government...

Biden Administration Proposes Novel Use Of Price As Justification For Agency Exercise Of March-In Rights For Government-Funded...

Presented as part of its effort to lower what it views as excessive prices for prescription drugs, the Biden administration on December 7, 2023, announced the release of a proposed framework to expand the use of government...more

McDermott+

McDermottPlus Check-Up: April 28, 2023

McDermott+ on

Congress was in session, and it was a busy healthcare week at the committee level, with six hearings focused specifically on health issues. On the House floor, Republicans passed the Limit, Save, Grow Act—a bill that raises...more

Goodwin

Pharma Manufacturer Federal Government Price Reporting: Recent Litigation and Settlements

Goodwin on

​​​​​​​Litigation involving drug price reporting under the Medicaid Drug Rebate Program (MDRP)  has been very active in 2022. Most recently, on August 3, 2022, an Illinois federal jury levied a $61 million verdict against Eli...more

Morgan Lewis

What the Future May Hold for Pharma Regulation Under the Biden Administration

Morgan Lewis on

Under President Joe Biden, pharmaceutical regulation may see increased FDA guidance, new strategies to speed up innovation and regulatory review, and a renewed focus on diseases with unmet needs, among other expectations....more

Hogan Lovells

[Webinar] Looking ahead to 2021: Impacts of the election for the life sciences and health care industry - November 19th, 12:30 pm...

Hogan Lovells on

Life Sciences and Health Care Horizons virtual event series - The fast pace of innovation in the life sciences and health care industry has reached an all-time high in 2020 as the industry grapples with the new reality of...more

Akin Gump Strauss Hauer & Feld LLP

What's New in Washington - September 2020

As the November elections rapidly approach, Congress faces a number of key legislative deadlines, including the need to fund federal agencies and extend expiring federal programs at the conclusion of the current fiscal year...more

Proskauer - Minding Your Business

Beyond the Pandemic: Pharmaceutical Industry Compliance Considerations

Since the ongoing states of emergency were put in place in response to a health crisis, pricing in the pharmaceutical industry is under more of a microscope than usual. While the immediate focus may be on products that are...more

Hogan Lovells

Life Sciences and Health Care Horizons - 2020

Hogan Lovells on

We are pleased to provide you with the third annual installment of our Life Sciences and Health Care Horizons guide. For each of these guides, we have asked our industry thought leaders throughout the world to write about...more

Akin Gump Strauss Hauer & Feld LLP

What's New in Washington - September 2019

Congress returns to D.C. this week for a short three-week sprint to a series of important deadlines on September 30. Chief among them is funding the federal government for Fiscal Year (FY) 2020 which begins on October 1,...more

BakerHostetler

The Weekly Hill Update

BakerHostetler on

Below is the Federal Policy team’s weekly preview, published each week when Congress is in session. HEADLINES - Negotiations over border security legislation have stalled, casting doubt on government funding beyond this...more

Searcy Denney Scarola Barnhart & Shipley

Can HEAL Do It For America’s Opioid Epidemic?

Government Initiative Promises $1.1 Billion in Research Funds - The U.S. Department of Health & Human Services’ National Institutes of Health has launched a brand-new – and much-necessary – initiative to combat the...more

Akin Gump Strauss Hauer & Feld LLP

United States Intervenes in Suit Against Private Equity Firm Based on Health Care Portfolio Company's Alleged False Claims Act...

• In an unusual move, the government has decided to pursue a False Claims Act (FCA) suit against a private equity firm based on an alleged commission scheme at its pharmacy portfolio company to promote sales of products...more

Sheppard Mullin Richter & Hampton LLP

Finding Common Ground in the Healthcare Debate: Federal, State, and Local Governments Respond to the Opioid Epidemic

As stories and statistics of the opioid crisis become increasingly prevalent in our national discourse, we are seeing a stronger, more innovative, and more aligned push for interventions across communities, government...more

Ballard Spahr LLP

Obama Signs 21st Century Cures Act, Adding $6.3 Billion For Medical Research

Ballard Spahr LLP on

The Cures Act aims to increase the speed by which new drugs are brought to market by streamlining clinical trials, allowing the use of patient data in the regulatory review process, and modernizing U.S. Food and Drug...more

Knobbe Martens

The Passage of the 21st Century Cures Act by Congress will produce Sweeping Changes to the Biotech, Medical Device,...

Knobbe Martens on

The December 8, 2016 passage of the 21st Century Cures Act by Congress is expected to lead to sweeping changes to the biotech, medical device and health industries and streamline the regulatory system for approval of both...more

Skadden, Arps, Slate, Meagher & Flom LLP

The 21st Century Cures Act: FDA Reforms Aim to Spur Innovation in the Pharmaceutical, Medical Device and Health Research Sectors

On December 13, 2016, President Obama signed into law the 21st Century Cures Act (Act), one of the most important pieces of health care and life sciences legislation in several decades. The Act is intended to spur the rapid...more

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

Catching up on developments posted on the blog

Some quick updates on stories I have been following: SENTENCING FOR DEADLY PAIN-MEDS DOC: An Orange County, CA., physician has been sentenced to 30 years to life imprisonment. She was convicted of murder for her...more

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