| Montag, 12. Mai 2025 - Freitag, 16. Mai 2025 |
We are proud to sponsor BioNJ’s 2025 BioPartnering Conference and are pleased to announce that partners Suzanne Filippi and David Schwartz will speak during the event, with Suzanne providing opening remarks.
Partner Suzanne Filippi will deliver opening remarks regarding the impact of the BioNJ BioPartnering Conference on Tuesday, May 13, 2025, from 8:20–8:45 am ET and Partner David C. Schwartz will present on the panel Preparing for Exit in a Volatile Market on Tuesday, May 13, 2025, from 9:20–9:50 am ET. This panel will discuss current market volatility and consider strategies to best position companies for subsequent liquidity events.
FDA Regulatory Uncertainty Calls for Strategic Decision-Making by Drug Developers
The recent reductions in the US Food and Drug Administration’s workforce are poised to have a substantial impact on drug and biologic development programs. This LawFlash discusses strategies to optimize interactions with the Agency and keep development programs on track.
Key Considerations for Foreign Clinical Trials When Looking Abroad for Product Development
With the continuing cuts to FDA staffing, the pharmaceutical and biotechnology industries are communicating increasing concern about potential product development impacts. While these cuts and their subsequent effects may be leading some companies to consider developing drugs abroad, such ex-US development can come with risks, necessitating upfront planning and compliance controls.
From Offshore to Onshore: Considerations for Pharmaceutical Industry Stakeholders Amid New Domestic Drug Manufacturing EO
to find ways to facilitate the opening of new drug manufacturing sites in the United States while also increasing the pressure on foreign drug and component manufacturers. As a result, pharmaceutical companies now face heightened pressure—and new incentives—to relocate operations domestically, as well as new challenges to manufacturing or sourcing finished pharmaceuticals and their components abroad. Accordingly, companies must grapple with complex regulatory and operational considerations.
FDA Drug Inspections Post–Workforce Reductions: Potential Implications and Practical Steps Forward
The FDA is confronted with significant challenges in its inspection processes due to recent layoffs. Among other effects, the latest reduction in force of full-time FDA employees is raising concerns about the potential impact on drug and biologic manufacturing inspections.
Several Planned DEA Actions Remain Pending as New DEA Administrator Awaits Confirmation
The US Senate held a confirmation hearing on April 30, 2025 for Terrance C. Cole, the president’s nominee for the administrator of the Drug Enforcement Administration. Although Administrator-nominee Cole’s policy priorities for the agency remain unclear, once confirmed and sworn in, he will find several pending regulatory matters waiting for him that could significantly affect industry stakeholders with controlled substance and/or listed chemical operations.
How New Executive Orders May Affect FDA’s Medical Device Operations
Several executive orders signed by US President Donald Trump may have significant implications for the US Food and Drug Administration (FDA) and its regulatory oversight for medical device and digital health products. These executive orders may, for example, delay pending regulations, create uncertainty for FDA’s prior guidance related to artificial intelligence, and adversely impact FDA staffing and resources.
Federal Court Blocks FDA’s Final Rule on LDTs: Key Considerations for Clinical Labs
The US District Court for the Eastern District of Texas issued a pivotal ruling in the consolidated lawsuit American Clinical Laboratory Association v. US Food and Drug Administration (FDA) challenging FDA’s final rule to end its longstanding policy of enforcement discretion for laboratory-developed tests (LDTs) and regulate them as medical devices. The court ruled in favor of the plaintiffs, bringing to a halt FDA’s planned regulatory oversight for LDTs.
Drug Pricing & Access in 2025: Issues to Watch and Developing Strategies
The pharmaceutical industry is a critical component of the global economy, impacting public health, national security, and economic stability. Recent developments—including investigations into the national security implications of pharmaceutical imports, executive actions aimed at reducing prescription drug prices, and the evolving role of pharmacy benefit managers (PBMs)—highlight the complex interplay of policy, economics, and healthcare.
US Administration Signals Potential Changes to Inflation Reduction Act Drug Price Negotiations
In response to manufacturer concerns over opaque Inflation Reduction Act (IRA) drug price negotiations, the US administration announced on January 29, 2025, that it would explore ways to increase transparency. Manufacturers advocate for a more formulaic approach, urging CMS to assign weighted values to each statutory negotiation factor.
IRA Litigation: Manufacturers Challenge CMS’s Definitions of ‘QSSD’ and ‘Bona Fide Marketing’
Drug manufacturers remain steadfast in their efforts to challenge the constitutionality of the Inflation Reduction Act’s mandatory price negotiation provisions. Recently filed suits contend that CMS has impermissibly expanded the definitions of “qualifying single source drug” and “bona fide marketing” beyond the statutory text resulting in the selection of drugs that should not have otherwise been selected for price negotiation. And, with CMS’s early announcement on January 17 of drugs selected for negotiation for Initial Price Applicability Year 2027, drug manufacturer litigation challenging program implementation is nearly certain to continue in 2025.
Please contact Steven Perdziola.