Podcast — Drug Pricing: How the Demise of Chevron Deference and Other Litigation May Impact the Pharmaceutical Industry
Understanding Pharmacy Benefit Managers: The PBM Landscape Explained
Podcast — Drug Pricing: How Are Payers Responding to the IRA?
340B Drug Pricing Program Compliance
Inflation Reduction Act’s Drug Price Negotiation Provisions – What Now? – Diagnosing Health Care Podcast
Podcast: Inflation Reduction Act’s Drug Price Negotiation Provisions – What’s Next? - Diagnosing Health Care
Podcast: Chevron Deference: Is It Time for Change? - Diagnosing Health Care
Part Two: The MFN Drug Pricing Rule and the Rebate Rule: Where Do We Go From Here?
Part One: Two new Medicare Drug Pricing Rules in One Day: What are the MFN and the Rebate Drug Pricing Rules?
On the Ballot 2020: Health Care Policy Outlook - Diagnosing Health Care Podcast
Podcast: IP(DC): Drug Prices, Political Pressures & Patents
Drug Pricing Initiatives During the Trump Presidency
K&L Gates Triage: An Insider’s Perspective on the Health Care Debate in Washington, DC
K&L Gates Triage: 340B Regulatory Update: CMS Proposal and Draft Executive Order Could Have Big Impact on 340B Program
K&L Gates Triage: 340B Eligibility - Hospital Covered Entities
Measures of success: How value-based pricing may change the pharmaceutical industry
On September 17, Express Scripts, Inc. (“Express Scripts”), one of the largest pharmacy benefit managers (PBMs) in the United States, brought suit against the Federal Trade Commission (“FTC”) over its July 2024 interim...more
This article is part of a monthly column that considers the significance of recent Federal Trade Commission announcements about antitrust issues. In this installment, we discuss the FTC's complaint on PBMs' conduct around...more
News Briefs - House Committee Approves Telehealth Modernization Act of 2024 - A House committee voted to advance a bill that would extend telehealth flexibilities in Medicare for another two years. The legislation, called the...more
FTC’s challenge is the culmination of years of investigation, but choice of venue and theories of harm reveal potential weaknesses....more
On September 20, the Federal Trade Commission (FTC) filed its first administrative complaint against PBMs under Chair Lina Khan, alleging "anticompetitive and unfair rebating practices” by the three largest PBMs that have...more
Tensions between the Federal Trade Commission (FTC) and pharmacy benefit managers (PBMs) continue to mount, bringing PBM practices and calls for reform back into the spotlight. On September 17, 2024, one of the largest PBMs,...more
The Biden administration’s antitrust scrutiny of the life sciences industry continued this week as the Federal Trade Commission (FTC) filed an administrative complaint against the nation’s largest pharmacy benefit managers...more
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
At an Open Commission Meeting on August 1, 2024, the Federal Trade Commission (FTC) presented a report prepared by its staff entitled Pharmacy Benefit Managers: The Powerful Middlemen Inflating Drug Costs and Squeezing Main...more
It has been a busy year for issues related to drug pricing, and with the election around the corner, litigation issues that have been developing over the last few years are likely to be a key focus for the second half of...more
The Cozen Lens - While it’s becoming ever clearer Vice President Harris is likely to be the Democratic nominee following President Biden’s decision to step aside, it’s less clear what the impact will be on the presidential...more
Exactly two weeks after issuing an interim staff report on Pharmaceutical Benefit Managers (PBMs) pursuant to its Section 6(b) authority to study markets, the Federal Trade Commission (FTC) has initiated another 6(b) study...more
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: •Gasoline Trading Firms to Pay $50 Million to Settle...more
The Federal Trade Commission (FTC) has called attention in the past year to its perception of the influence that branded pharmaceutical companies have over the price of beneficial drugs. Most recently, the agency has asserted...more
The Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch-Waxman Act, forms the current framework for the United States’ regulation of drug approvals. The law amended the Food, Drug, and...more
Key Points - GLP-1 agonists have ushered in a new era in anti-obesity medication policy considerations against the backdrop of a continued focus by policymakers on both drug access and pricing. CMS has taken steps to clarify...more
The Inflation Reduction Act of 2022 (IRA) was signed into law by President Biden on August 16, 2022, and includes key sections addressing climate and clean energy, corporate taxes and health care. The health care provisions...more
News Briefs - Groups Urge Appeals Court to Revive Drug Price Negotiation Suit - Healthcare and drug industry groups urged a U.S. appeals court to revive their challenge to a law requiring manufacturers to negotiate the prices...more
This week, the FTC continued its intense regulatory focus on pharmaceutical patents listed in the FDA’s Orange Book. As reported in earlier editions of The Interplay, the FTC issued a policy statement in September 2023,...more
In a recent Federal Register notice, the PTO announced a proposed rule requiring that any settlement agreement resolving a PTAB proceeding, even if such agreement occurs prior to a decision to institute an inter partes review...more
In recent remarks prepared for delivery to the White House roundtable on pharmacy benefit managers (PBMs), Federal Trade Commission (FTC) Chair Lina Khan made clear that the FTC’s investigation into PBM practices continues....more
On March 5, the Federal Trade Commission (FTC), U.S. Department of Justice’s Antitrust Division (DOJ), and Department of Health and Human Services (HHS) jointly issued a Request for Information on Consolidation in Health Care...more
Appropriations Update. On March 3, Congress released bill text for the CAA, 2024, which includes funding for six of the 12 appropriations bills: Agriculture-FDA, Military Construction-VA, Energy-Water, Transportation-HUD,...more
The Federal Trade Commission (FTC) and the Department of Health and Human Services (HHS) are soliciting public comments on the root causes of and potential solutions to drug shortages. The request for information (RFI)...more
On February 6, 2024, the Federal Trade Commission (“FTC”) commented in support of what would be a historic expansion of government march-in rights under the Bayh-Dole Act in response to the release of the National Institute...more