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Proposed Legislation FDA Approval

King & Spalding

Administrative, Congressional, and State Interest Signal a Potential Breakthrough Moment for Psychedelics

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The development of innovative pharmaceuticals targeting refractory mental health conditions has stagnated for decades. In recent years, however, psychedelics have garnered scientific and public attention for their potential...more

Morgan Lewis

How the Health Tech Investment Act Could Reshape Medicare Reimbursement for Algorithm-Based Services

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As AI transforms medicine, some of the most promising healthcare innovations are at risk of exclusion by Medicare’s outdated and complex reimbursement structures. The Health Tech Investment Act, or S. 1399, introduced in...more

Venable LLP

BiologicsHQ Monthly Injection - March 2025

Venable LLP on

On March 17, 2025, Senators Chuck Grassley (R-IA), John Cornyn (R-TX), Richard Blumenthal (D-CT), and Richard Durbin (D-IL) re-introduced the “Affordable Prescriptions for Patients Act” (“APPA”), which previously passed the...more

Venable LLP

Potential Impact of the Affordable Prescriptions for Patients Act Patent Limit on BPCIA Litigations

Venable LLP on

On March 17, 2025, Senators Chuck Grassley (R-IA), John Cornyn (R-TX), Richard Blumenthal (D-CT), and Richard Durbin (D-IL) re-introduced the “Affordable Prescriptions for Patients Act” (“APPA”), which previously passed the...more

Goodwin

New Momentum for a Time-Limited Conditional Approval Pathway for Rare Disease Drugs

Goodwin on

On October 4, 2024, a US House version of the revised Promising Pathway Act (PPA) 2.0 was introduced, sponsored by Rep. Bruce Westerman (R-AR). ...more

Shook, Hardy & Bacon L.L.P.

Food and Beverage Litigation and Regulatory Update - October 2024 #2

The Animal Legal Defense Fund (ALDF) and a coalition of 16 other organizations and individuals have submitted a petition for rulemaking calling on the U.S. Food and Drug Administration (FDA) to require that products...more

Venable LLP

Senator Mike Lee Introduces the Biosimilar Red Tape Elimination Act to Eliminate Switching Study Requirement for Biosimilar...

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On November 17, 2022, Senator Mike Lee (R-UT) introduced the “Biosimilar Red Tape Elimination Act” to increase biosimilar competition and reduce patient costs by prohibiting the FDA from requiring switching studies to approve...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, November 2020 # 12

Hogan Lovells on

In Washington: Wednesday, the House held its leadership elections reelecting Rep. Nancy Pelosi (D-CA) as Speaker of the House by her caucus. Other top Democratic leaders, Majority Leader Steny Hoyer (D-MD) and Majority...more

Seyfarth Shaw LLP

FDA and NCI to Review COVID-19 Antibody Tests Marketed Under FDA Guidance Permitting Sale Without FDA Authorization

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In mid-March, the US Food and Drug Administration announced via press release an “unprecedented policy” to increase testing capacity for COVID-19 in the United States. As part of its Policy for Diagnostic Tests for...more

Hogan Lovells

Senate bill proposes laboratory developed tests to be regulated under CLIA process

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U.S. Senator Rand Paul introduced legislation that would place laboratory developed testing procedures within the Clinical Laboratory Improvement Amendments (CLIA) process and assess the availability and utilization of...more

Mintz - Health Care Viewpoints

Congress Looking to Streamline CBD Drug Research

We’ve previously blogged about the regulation of CBD by the Food and Drug Administration (FDA), and it appears that the dialogue around CBD isn’t slowing down as we continue through the second half of 2019. Recently, a...more

Foley & Lardner LLP

Health Care Policy Newsletter - July 2018

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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

Hogan Lovells

A new right for American patients: The Right to Try

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On May 22, 2018, the U.S. House of Representatives passed Senate Bill 204, commonly known as the “Right to Try Act of 2017” by a vote of 250-169. The bill gives certain patients with life-threatening conditions the right to...more

Farrell Fritz, P.C.

Cannabis Industry Update – April 2018

Farrell Fritz, P.C. on

With so much happening in the cannabis industry we thought we’d take this time to highlight some of the industry’s most recent happenings. ...more

Hogan Lovells

Outlook for OTC drug regulation

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Significant change is on the horizon for the over-the-counter (OTC) drug industry. OTC drug sales have grown from about US$3 billion in 1972 to over US$34 billion today, with over 300,000 products marketed. ...more

Holland & Knight LLP

Congress Takes Up FDA Over-The-Counter (OTC) Drug Regulation Reform

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On September 13, the U.S. House of Representatives Energy and Commerce Committee’s Subcommittee on Health held a hearing to examine draft legislation to create a new user fee program and completely revamp the review process...more

Knobbe Martens

New Proposed Legislation: Doctors Must Report Med Device-Related Deaths & Injuries

Knobbe Martens on

Representatives Mike Fitzpatrick (R-PA) and Louise Slaughter (D-NY) announced plans to propose the Medical Device Guardians Act of 2016. According to a press release from Rep. Fitzpatrick, the Act is “a package of bills aimed...more

Benesch

Senators Introduce the CREATES Act

Benesch on

In furtherance of the government’s efforts to bring down healthcare costs, Senators Patrick Leahy (D-VT.), Chuck Grassley (R-IA), Amy Klobuchar (D-MN), and Mike Lee (R-UT) have introduced the Creating and Restoring Equal...more

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