News & Analysis as of

Manufacturers Drug Pricing Generic Drugs

White & Case LLP

Three Drug Pricing Litigation Issues to Watch in the Second Half of 2024

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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

Array

eDiscovery and ANDA Litigation: Unique Timelines, Processes, and Workflows

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ANDA litigation is a high-stakes niche of pharmaceutical law that presents unique challenges not only for lawyers, but also for eDiscovery practitioners. Here’s why: under the Drug Price Competition and Patent Term...more

Ankura

Summary: The Government Accountability Office's Report on Medicare Part D Rebates

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On September 5, 2023, the United States Government Accountability Office (GAO) published its report titled Medicare Part D: CMS Should Monitor Effects of Rebates on Plan Formularies and Beneficiary Spending.The report...more

Mintz - Health Care Viewpoints

Mintz IRA Update — Basics of the Medicare Drug Price Negotiation Program

The Inflation Reduction Act (“IRA”) was passed just over a year ago with a goal of lowering high drug costs for Medicare beneficiaries and reducing costs incurred by Medicare. A central piece to achieving the IRA’s goal of...more

Manatt, Phelps & Phillips, LLP

[Webinar] Implications Across the Health Care System of the New Federal Drug Price Regulation - September 22nd, 1:00 pm - 2:00 pm...

The Inflation Reduction Act of 2022 (IRA) includes the most dramatic change to U.S. drug price regulation in history. The new law allows the federal government to “negotiate” the price of many drugs dispensed to Medicare...more

McDermott Will & Emery

Fourth Circuit Breathes New Life into Monopolization Suit

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The US Court of Appeals for the Fourth Circuit revived an antitrust suit alleging that a pharmaceutical manufacturer illegally maintained its monopoly for its innovator drug by precluding competition beyond the expiration...more

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

Generic drugs ensnared in price-fixing and shoddy manufacturing claims

With Big Pharma pressing the limits in promoting and pricing prescription medications, patients and their advocates long have hoped that generic drugs might be difference-makers on costs and practices. Those positive wishes,...more

Wilson Sonsini Goodrich & Rosati

FDA Issues Competitive Generic Therapies (CGTs) Statement and Guidance Regarding CGT Designation, Approval Pathway, and Market...

Recently, the United States Food and Drug Administration (FDA) Commissioner Scott Gottlieb issued a statement (the statement) outlining a new policy to improve access and foster price competition for branded drugs that are...more

Hogan Lovells

China Takes Significant Steps to Consolidate Generic Drug Industry and Lower Prices

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With the opportunity for global pharmaceutical companies to gain new access to the Chinese market presenting itself like never before, significant news broke on December 7, 2018, regarding a newly implemented pilot...more

Akin Gump Strauss Hauer & Feld LLP

What's New In Washington - September 2018

Following a truncated August recess, the House and the Senate returned to Washington after Labor Day with a full plate of legislative items to address prior to the end of the fiscal year on September 30. That list includes...more

Patterson Belknap Webb & Tyler LLP

Fourth Circuit Rules that Maryland’s Anti-Price Gouging Act for Off-Patent or Generic Drugs is Unconstitutional

The U.S. Court of Appeals for the Fourth Circuit last month handed manufacturers and wholesalers of off-patent drugs a victory by ruling that Maryland’s anti-price gouging act violates the U.S. Constitution’s dormant commerce...more

Mintz

FTC Hosts Workshop – “Understanding Competition in Prescription Drug Markets: Entry and Supply Chain Dynamics”

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On Wednesday, November 8, 2017 the Federal Trade Commission (FTC) hosted a workshop seeking to explore the general question of why the cost of prescription drugs has risen greatly in recent history. The Workshop was framed...more

Arnall Golden Gregory LLP

California Enacts Limitations on Copayment Coupons

As prescription drug pricing continues to dominate political headlines, state legislatures are taking action intended to lower drug prices for health plans and patients. Despite industry opposition, California has enacted a...more

Blank Rome LLP

Targeting Generic Drug Prices

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For years, states and the federal government focused their drug pricing enforcement efforts on higher priced and more expensive branded drugs. Not surprisingly, private qui tam lawyers followed on the coattails of these...more

Foley & Lardner LLP

Three Dozen States Sue Makers of Opioid Addiction Treatment Medications for Antitrust

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With opioid abuse continuing to dominate national headlines, manufacturers of opioid overdose medications are facing intense scrutiny over pricing practices that threaten (or those perceived as threatening) public...more

Benesch

Senators Introduce the CREATES Act

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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

Mintz - ML Strategies

Transparency in Drug Pricing: Issues to Consider from the Research Lab to the Consumer

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Since 2014, drug pricing has grown in importance in health care policy conversations. From Gilead Sciences’s Hepatitis C treatment costing $84,000 per course of treatment to Turing Pharmaceutical’s 5,000 percent price hike of...more

Foley & Lardner LLP

Are Drug Prices Really Too High?

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Those working in the pharmaceutical space are used to hearing complaints about the high costs of drugs, and patents often are blamed for allowing pharmaceutical companies to charge “too much” for their products. But are drug...more

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