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Biden Administration Prioritizing Domestic Production of Pharmaceuticals . . . Again?

On November 27, the Administration announced another blue-ribbon panel to bolster the domestic manufacturing of pharmaceuticals. This one is called the Supply Chain Resilience Council. Co-chairs of the Council are Lael...more

CMS Proposing Major Changes to Medicaid Drug Rebate Program

While you were at a Memorial Day barbeque, the Centers for Medicare & Medicaid Services (“CMS”) proposed major changes to the Medicaid Drug Rebate Program (“MDRP”). 2023-10934.pdf (federalregister.gov). Comments on the...more

Nevada Publishes 2023 Drug Price Transparency Lists

On January 31, 2022, the Nevada Department of Health and Human Services (“DHHS”) released its annual drug lists in accordance with its Drug Transparency Reporting Program. DHHS published four drug lists: List #1 Essential...more

The Medicaid Drug Rebate Program and Value-Based Purchasing

On March 23, 2022, the Centers for Medicare and Medicaid Services (“CMS”) issued long-awaited guidance regarding how drug manufacturers are to report multiple best prices (“BPs”) to the Medicaid Drug Rebate Program (“MDRP”)...more

Biden Administration Initiatives to Rein in Drug Prices—Déjà vu All Over Again

On July 9, President Biden signed Executive Order 14063, designed to promote competition in the American economy with the goal of lowering prices for families, increasing wages for workers, and promoting innovation and even...more

Under Biden Administration, Will Federal Drug Pricing Transparency Efforts Continue to Outpace State Laws?

During 2019 and 2020, states enacted fewer laws requiring drug manufacturers to disclose pricing and related information. Initially, the slowdown may have been due to federal actions to rein in drug prices through the Trump...more

Biden Administration Already Impacting Drug Prices

The Trump administration issued numerous Executive Orders seeking to rein in drug prices. (See Recent and Possible Executive Orders on Drug Pricing: What You Need to Know – Government Contracts Navigator and Administration...more

Administration Issues Executive Order Tying Medicare Drug Costs to International Prices

On Sunday, while everyone was watching the return of NFL football, the Administration was busy fulfilling a promise it made in July to lower drug prices paid by the United States and Medicare beneficiaries by tying pricing to...more

Executive Order Regarding Domestic Production and Purchase of Essential Medicines: A Lot to Unpack and More Than Meets the Eye

On August 6, 2020, President Trump issued another Executive Order (“EO”) that will likely have dramatic and long-lasting effects on the pharmaceutical industry. The impact of the EO may be far greater than currently...more

Recent and Possible Executive Orders on Drug Pricing: What You Need to Know

On July 24, 2020, President Trump signed three Executive Orders aimed at lowering prescription drug costs and increasing patients’ access to life-saving medications. A fourth Executive Order was discussed, which could reduce...more

Federal Circuit Holds Generic Drugs Manufactured in the U.S. from API Produced in India Qualify for Sale to U.S. under Trade...

Earlier today, the United States Court of Appeals for the Federal Circuit issued a decision that is sure to send shockwaves through the generic drug industry....more

Federal Drug Pricing Transparency Efforts Outpace State Laws Requiring Drug Manufacturer Price Reporting for the First Half of...

During 2017 and 2018, states took the reins in terms of enacting laws compelling drug manufacturers to disclose drug pricing. State activity has slowed during the first six months of 2019. Instead, during the first half of...more

Will HHS’s Safe Importation Action Plan Affect How the Federal Government Purchases Drugs?

On July 31, the Department of Health and Human Services (“HHS”) and the Food and Drug Administration (“FDA”) announced their latest plan to reduce the prices Americans pay for prescription drugs. The Safe Importation Action...more

What’s Happening with Drug Manufacturer Pricing Disclosure Law?

After identifying recent federal efforts that would require drug pricing transparency, this article discusses two state laws enacted recently. Thereafter, the article assesses previously enacted state laws requiring drug...more

States Pass Fewer Drug Manufacturer Pricing Disclosure Laws in 2018

Merle M. DeLancey Jr. While the introduction of state legislation that would require drug manufacturers to disclose pricing and other information did not slow down in 2018, the number of bills that were made law did slow...more

Drug Manufacturer Pricing Disclosures: Mid-Year 2018 Update

Earlier this year, I commented on state drug pricing transparency laws in effect and/or enacted during 2017. I also opined that it was likely more states would pass similar transparency laws requiring drug manufacturers to...more

2017 Was a Busy Year for State Imposition of Drug Manufacturer Price Disclosure Obligations and 2018 Isn’t Looking Much Better

Although several bills were introduced in Congress and President Trump has complained that drug prices are way too high, during 2017, the federal government did not pass any law nor implement any policy requiring drug...more

Targeting Generic Drug Prices

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

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