In response to the Office of Management and Budget’s recent Request for Information on Deregulation, PULSE urged federal regulators to revisit the latest changes to the Hart-Scott-Rodino (HSR) premerger notification rule. As noted in PULSE’s comments, the recent HSR rule imposes an unnecessary regulatory burden that will stifle pro-competitive mergers and acquisitions (M&A), which are fundamental to the life sciences ecosystem and often essential to bringing new treatments and cures to patients.
PULSE strongly believes that the substantial costs of the HSR rule, including fewer options for patients, significantly outweigh any stated benefits for the Federal Trade Commission.
Key takeaways from PULSE’s comment letter are included below:
1. M&A Plays a Unique and Fundamental Role in America’s Life Sciences Industry
- “Breakthrough treatments and cures are rarely the work of one actor alone. Rather, they are often the result of a collaborative process, where early-stage biotechnology firms advance promising research and development (R&D), investors contribute significant funding against high risks and more established companies contribute the substantial regulatory expertise, technical capabilities and infrastructure needed to bring medicines to patients at scale.”
- “Life sciences M&A uniquely allows companies of all sizes to specialize in what they do best, and partner to combine complementary capabilities and advance new medicines from the lab to patients.”
2. The Final HSR Rule Imposes a Significant Burden on American Life Sciences Companies of All Sizes
- “The final rule issued by the Federal Trade Commission (FTC) in October 2024 imposes a significant burden on the life sciences industry, and particularly for early-stage companies, while doing very little to enhance competitive outcomes.”
- “Importantly, this burden applies broadly to all proposed mergers, despite the FTC’s own data showing that 98% of mergers pose no risk to competition. In the life sciences industry, this rule threatens to impede a critical pathway to bring new treatments to market and chill investment in the next generation of medicines.”
3. Revisiting the HSR Rule Would Support America’s Leadership in Life Sciences Innovation
- “Flawed merger enforcement policies risk undermining the world-class U.S. life sciences ecosystem by chilling investment, pushing away talent and even leading U.S.-based startups to relocate to other jurisdictions. Without clear and efficient merger review regulations, we risk losing both a vital economic engine and our global leadership in developing life-saving treatments.”
- “By reducing the unnecessary burden of the HSR requirements, we can ensure that America’s life sciences ecosystem remains the most dynamic and innovative in the world, delivering cures to patients and bolstering our nation’s economy.”
As underscored in PULSE’s comments, revisiting the new HSR rule is a critical step that would reduce unnecessary red tape for companies engaging in pro-competitive life sciences M&A for the benefit of patients. To maintain America’s leadership in biopharmaceutical innovation, regulators must recognize and support — rather than impede — the unique and fundamental role of these partnerships.
To read PULSE’s full comment letter and learn about specific recommendations for HSR reform, please click here.