Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 247: Reimagining Cell Therapy for Solid Tumors with Ming-Wei Chen and Fangheng Zhou of RephImmune
HHS Policy Changes, Supreme Court Rulings, and the DOJ-HHS False Claims Act Working Group
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 246: The Next Generation of Treatment for Alzheimer's and Parkinson’s with Neal Goodwin and Pawel Krysiak of Jaya Bio
AI Today in 5: August 11, 2025, The ACHILLES Project Episode
False Claims Act Insights - Bitter Pills: DOJ Targets Pharmacies for FCA Enforcement
Key Discovery Points: BYOD Case Law Covering Subpoenas and Employee Handbooks
Daily Compliance News: June 23, 2025, The Is Walmart Cool Edition
Taking the Pulse: A Health Care & Life Sciences Video Podcast | Episode 239: Understanding the 340B Pricing Program with Chuck Melendi of Disruptive Dialogue
Unexpected Paths to IP Law with Dan Young and Colin White
Navigating Legal Strategies for Covering GLP-1s in Self-Insured Medical Plans — Employee Benefits and Executive Compensation Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 234: Life-Saving Collaboration in the Life Sciences Industry with John Crowley, President & CEO of BIO
AGG Talks: Cross-Border Business Podcast - Episode 28: How Life Sciences Companies Can Create a Culture of Compliance When Expanding to the U.S. Market
How Life Sciences Companies Can Create a Culture of Compliance When Expanding to the U.S. Market
Podcast - Hot Topics in FDA Regulation: GLP-1s, LDTs, AI and More
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 231: Advancing the Life Sciences Industry with Kendalle O’Connell of MassBio
Compliance Program Effectiveness: Keep it Streamlined and Strategic
AGG Talks: Cross-Border Business Podcast - Episode 26: U.S. Enforcement Trends Targeting Foreign Pharmaceutical and Medical Device Manufacturers
Podcast — Drug Pricing: 2025 J.P. Morgan Healthcare Conference Takeaways and Outlook
Prescribing GLP-1 Medications: Be Aware of Legal Limitations
Podcast — The Growth Rocketship: How BridgeBio’s Hub and Spoke Portfolio Strategy Set the Market for the Future of Biotech — Then, Now, and What’s Next?
As detailed in our February 24, 2025 update, House Bill 123 continues the operations of the Alabama Board of Pharmacy (“the Board”) until October 1, 2026, with changes to the Board’s structure, operations, and practices....more
In an attempt to increase the availability of biosimilars, on July 11, 2024, the Senate passed the Affordable Prescriptions for Patients Act, which was introduced in the House on July 19, 2024. The bill sets a cap of 20...more
Avid readers know we have speculated that the legalization of psychedelics as a prescription medicine was “closer than ever.” Unfortunately, for proponents of the legalization of psychedelics like MDMA, progress is rarely a...more
In the grand experiment of American democracy, it is often said that states serve as laboratories, testing policies that challenge the status quo without risking the stability of the whole. Oregon, known in recent years for...more
The Lower Costs More Transparency Act of 2023, passed by the House 320-71 on Monday, December 11, 2023, would institute new transparency and pricing rules on pharmacy benefit managers (PBMs) and hospitals. The bill would...more
Historic statute introduces mandatory Medicare price negotiations, Medicare Part B and D inflation rebates, and Medicare Part D benefit redesign. H.R. 5376, the Inflation Reduction Act of 2022 (the Act), marks Congress’s...more
On August 7, 2022, the U.S. Senate passed the Inflation Reduction Act of 2022, which includes some of the most significant drug pricing-related changes since the passage of the Medicare Prescription Drug Improvement...more
The Big Molecule Watch is monitoring pending legislation in Congress that relates to biosimilars and biologics. In this post, we check in on the status of two currently pending bills related to Citizen Petitions....more
The Senate passed a bill (S. 164) earlier this month (on March 3, 2021) “[t]o educate health care providers and the public on biosimilar biological products, and for other purposes.” The proposed “Advancing Education on...more
Global Warming Solutions Act: asking for too much or not enough? The House Committee on Energy and Technology took testimony this week on the The Global Warming Solutions Act. University of Vermont Professor Jon Erickson...more
The House and Senate continue to focus on prescription drug pricing though it is unclear whether any of the proposals currently pending in either chamber will become law. On December 6th, Senators Grassley and Wyden...more
On December 12, 2019, the U.S. House of Representatives passed a major Democratic drug-pricing bill, H.R. 3, or the “Elijah E. Cummings Lower Drug Costs Now Act.” If enacted, HHS would be allowed to negotiate the prices of...more
A recent piece of federal legislation intended to address the opioid crisis across the United States may have some unintended consequences. In attempting to prohibit “patient brokering” in the narrow context of addiction...more
In a September 14, 2018 Proclamation, President Donald Trump announced that the week of September 16 through September 22, 2018 would be Prescription Opioid and Heroin Epidemic Awareness Week (“Awareness Week”). As described...more
Two pieces of related legislation that would prohibit so called “gag clauses” in contracts between pharmacists and health plans and pharmacy benefit managers (PBM’s) have been passed by both the Senate and the House....more
On October 3, the U.S. Congress passed H.R. 6, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act (the SUPPORT Act), a wide-reaching bill that aims to...more
Congress has approved a major new push to deal with the opioid crisis that kills tens of thousands of Americans annually. Voters can expect President Trump to sign the big bill, passed easily and with rare bipartisan support...more
On September 25, 2018, House and Senate negotiators agreed on a final legislative package to address the opioid crisis. Following this agreement, the House passed the opioid package on September 28, 2018. The Senate is...more
As previously discussed in our post from September 2017, the push for a response to the opioid crisis is gaining momentum. Enter the “Opioid Crisis Response Act of 2018.” On May 7, 2018, the Opioid Crisis Response Act of...more
Medical Monitoring Bill Moves On - The House Judiciary Committee sent a version of S.197 to the Senate floor that eliminates the Senate-passed provisions creating strict, joint and several liability for release of harmful...more
The CREATES Act (Creating and Restoring Equal Access to Equivalent Samples Act), currently pending in Congress states as its aim to promote drug price competition by removing an impediment to the development and approval of...more
In January 2018, in the wake of the publication of the House Energy and Commerce Committee’s Review of the 340B Drug Discount Program, I wrote that it was too soon to know whether 2018 will be a game-changing year for the...more
The Judicial Panel for Multidistrict Litigation (“MDL Panel” or “Panel”) has transferred 97 putative class actions relating to the Equifax data breach to the Northern District of Georgia, where Equifax is headquartered. Judge...more
The Maine legislature passed with broad bipartisan approval L.D. 911, An Act to Prohibit Certain Gifts to Health Care Practitioners. The legislation prohibits gifts to practitioners who are licensed to prescribe and...more
Last week, the California Assembly Committee on Business and Professions voted in favor of Assembly Bill 315. AB 315 seeks to amend the California Business and Professions Code: (a) to require PBMs to obtain licensure from...more