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Food and Drug Administration (FDA) Legislative Agendas Prescription Drugs

Foley & Lardner LLP

Direct-to-Consumer Drug Ads Are Under Attack – Pharmaceutical Companies Beware

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On June 12, 2025, Senators Bernie Sanders (I-VT) and Angus King (I-ME) introduced the End Prescription Drug Ads Now Act (the Act) that would prohibit pharmaceutical companies and arguably any other entity engaged in...more

Holland & Knight LLP

Holland & Knight Health Dose: May 13, 2025

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U.S. House of Representatives committees are scheduled to begin markups on additional portions of the budget reconciliation package on May 13, 2025. Both the House Committee on Ways and Means and the House Committee on Energy...more

Cozen O'Connor

The State AG Report – 02.27.2025

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Here are curated AG and federal regulatory news stories highlighting key areas in which state and federal regulators’ decisions are having an impact across the US: •Congress Urged to Send Message to Organized Retail Crime -...more

Holland & Knight LLP

Holland & Knight Health Dose: February 25, 2025

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Holland & Knight Health Dose Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

Akin Gump Strauss Hauer & Feld LLP

2025 Perspectives in Private Equity: Health Care & Life Sciences

Private equity investors in health care and life sciences must navigate a complex and shifting landscape influenced by regulatory and policy changes and technological advancements. As private equity investments in the health...more

Holland & Knight LLP

Holland & Knight Health Dose: February 6, 2024

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

Bradley Arant Boult Cummings LLP

The Great Divide: The Feds’ Differing Approach to Psychedelics and Cannabis

Just as we did, the Food and Drug Administration has recognized the growing enthusiasm for exploring opportunities to use psychedelic medications to treat mental health disorders. In June, FDA issued for the first time draft...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

McDonnell Boehnen Hulbert & Berghoff LLP

Senate Once Again Tries to Address Drug Pricing

Over the past several years Congress has tried to address high drug prices, with variable success  (see "FTC to the Rescue Regarding High Drug Prices and Patents"; "Even More Ill-Conceived Remedies from Congress Regarding...more

Eversheds Sutherland (US) LLP

FDA says “no” to CBD: Now what?

The FDA’s recent decision not to regulate CBD like a food or dietary supplement leaves a multi-billion-dollar industry in a lurch. What’s next, and what should companies do now?...more

McDermott Will & Schulte

Special Report - 2022 FDA Year in Review

As the United States’ primary public health and consumer protection agency, the US Food and Drug Administration (FDA) regulates at least one quarter of the nation’s economy and exerts significant influence over global...more

Mintz - ML Strategies

Post-Election 2020 - Health Care Preview

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With the presidential transition underway, we now look forward to what the Biden administration will seek to accomplish, particularly in the realm of health care policy. President-elect Biden has been clear that he wants to...more

Seyfarth Shaw LLP

The Week in Weed: March 2020 #2

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FEDERAL NEWS - The big news this week was the FDA’s report to Congress on CBD.  The report did not set out a timeline for usage guidelines, citing the need for more data.  Commissioner Stephen Hahn did indicate he thought...more

McDonnell Boehnen Hulbert & Berghoff LLP

FDA Continues to Approve Biosimilars

The prevailing attitude in many quarters is that the Biologics Price Competition and Innovation Act (BPCIA) has not facilitated approval of drugs biosimilar to reference biologic drug products with sufficient alacrity and has...more

Skadden, Arps, Slate, Meagher & Flom LLP

Drug Pricing Concerns Drive Continued DOJ Focus on Life Sciences Companies

In 2019, U.S. Department of Justice (DOJ) enforcement activity targeting drug and device manufacturers jumped sharply over the prior year, reflecting an increased focus on fraud and abuse in the life sciences sector. More...more

Mintz - Health Care Viewpoints

Health Care Provisions in 2020 Spending Package

On December 20, 2019, the President signed into law a bill to fund the federal government through September 30, 2020. The bill included several important health care provisions but left some longstanding policy challenges...more

Wilson Sonsini Goodrich & Rosati

Sitting Here on Capitol Hill: November 2019

Congressional Developments on Life Science and Consumer Product Issues - Legislation - Citizen Petitions: House Subcommittee Approves Bill to Prevent Overuse - To address the abuse of citizen petitions that delay...more

Wilson Sonsini Goodrich & Rosati

Sitting Here on Capitol Hill: Congressional Developments on Life Science and Consumer Product Issues

Letters and Statements - Gene Therapy: Democratic Senators Urge the FDA to Hold Company Accountable for Falsifying Data - On August 9, 2019, a group of Democratic senators, including two presidential candidates, sent...more

Foley & Lardner LLP

Health Care Policy Happenings - October 2018

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...Alexander: Senate Sends Opioids Legislation Called “Landmark” by Leader McConnell to President – On Wednesday, the U.S. Senate passed by a vote of 98-1, the SUPPORT for Patients and Communities Act, sponsored by Senator...more

Womble Bond Dickinson

FDA Seeks to Provide Greater Insight on Off-Label Promotions of Pharmaceuticals

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The US Food & Drug Administration (FDA) serves as the gatekeeper between pharmaceutical companies and the public they serve, including governing how medications are promoted and advertised. Pharmaceutical companies want to go...more

Foley & Lardner LLP

Public Policy August Recess Health Care Newsletter

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Foley’s Bipartisan Public Policy Team is pleased to share our Public Policy August Recess Health Care Newsletter in which we compiled the top health care policy news and legislation from this month. The House was not in...more

Foley & Lardner LLP

Health Care Policy Newsletter - July 2018 #4

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Foley & Lardner LLP’s Bipartisan Public Policy Team is pleased to share this week’s “Public Policy Health Care Newsletter” in which we compile the latest health care policy news and legislation. Please note that the next...more

Hogan Lovells

FDA proposes new ways for prescription drugs to become available over-the-counter

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On Tuesday, FDA’s Center for Drug Evaluation and Research (CDER) announced a draft guidance titled “Innovative Approaches for Nonprescription Drug Products” that could aid drug manufacturers who want to sell, without a...more

Foley & Lardner LLP

Health Care Policy Newsletter - July 2018 pt 2

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Foley & Lardner LLP’s (“Foley”) Bipartisan Public Policy Team is pleased to share our “Public Policy Weekly* Health Care Newsletter” in which we compile the latest Health Care policy news and legislation. *Please note that we...more

Foley & Lardner LLP

Health Care Policy Newsletter - June 2018 pt 3

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Foley & Lardner LLP’s (“Foley”) Bipartisan Public Policy Team is pleased to share our “Public Policy Weekly* Health Care Newsletter” in which we compile the latest Health care policy news and legislation. *Please note that we...more

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