Georgia Bio Sign-on to State Medical Technology Alliance HHS & CMS Letter

In recent comments to the Department of Justice (DOJ) and Federal Trade Commission (FTC), PULSE highlighted critical reforms to ensure that U.S. competition policies support – and do not impede – the pro-competitive mergers and acquisitions (M&A) and other collaborations that drive American life sciences innovation. PULSE submitted comments in response to two joint DOJ/FTC Requests related to Guidance on Collaborations Among Competitors and Improvements to the Premerger Notification and Report Form (HSR Form). Read below for key takeaways from PULSE’s comment letters: 1. Life Sciences Innovation Depends on Collaboration “At its core, life sciences innovation is overwhelmingly collaborative. The cutting-edge medicines and cures developed by America’s life sciences industry are rarely the result of just one sole actor. Instead, they more often emerge from a calibrated sequence of partnerships… that collectively usher a biomedical breakthrough from early-stage discovery to FDA approval and delivery to patients.” – PULSE, Comments on Guidance on Collaborations Among Competitors 2. Policies that Ignore the Fundamental Role of Life Sciences M&A Risk Chilling Innovation for Patients “Against the significant challenges and pressures inherent to life sciences innovation, such policies that needlessly delay pro-competitive transactions have significant ripple effects: eroded investment incentives, disruptions in the path to launch and, ultimately, slowed or stalled development of new treatments and cures for patients.” – PULSE, Comments on Improvements to the HSR Form 3. Clear, Predictable Standards Can Support Competition and Innovation in America’s Life Sciences Ecosystem “Preserving clear and workable pathways for collaboration is therefore essential to sustain the broader ecosystem that delivers innovation and sustains America’s status as the world leader in life sciences innovation.” – PULSE, Comments on Guidance on Collaborations Among Competitors Leading business and industry organizations echoed and reinforced these priorities. Their comments highlight the unique market dynamics of life sciences innovation and the importance of collaboration and M&A – particularly with respect to early-stage R&D. “Because drug development typically takes over a decade, and the vast majority of drugs in development never make it to market, the antitrust risks associated with R&D collaborations in this space may be less than with other R&D collaborations.” – ABA Antitrust Law Section, Comments on Guidance on Collaborations Among Competitors “In the biopharmaceutical sector, for instance, R&D ventures in the pre-clinical or Phase I stages should be presumed lawful. At these early stages, about 90% of drugs never make it to market, so these collaborations are far too distant from commercialization to pose a meaningful threat to competition.” – U.S. Chamber of Commerce, Comments on Guidance for Collaborations Among Competitors “Healthy M&A activity also aids company formation and capital raising earlier in a business’s life cycle, as entrepreneurs and early-stage investors often depend on M&A for an exit opportunity. Conversely, discouraging business combinations by imposing burdensome one-size-fits-all standards on all transactions, like those imposed by the 2024 amendments, would disincentivize early-stage innovation and slow down economic growth.” – National Association of Manufacturers, Comments on Improvements to the HSR Form The bottom line: A balanced approach to antitrust enforcement policy should support life sciences M&A and other collaborations, ensuring new medicines continue to reach patients, while preserving a diverse and collaborative ecosystem. PULSE urges the agencies to adopt clear, workable and predictable standards that companies can apply with confidence. That includes preserving enforcement safety zones for low-risk, pro-competitive collaborations, as well as ensuring the HSR Form facilitates a timely, focused and fit-for-purpose screening process for life sciences M&A deals. Click below to read PULSE’s full comments: PULSE Comments on Guidelines on Collaborations Among Competitors PULSE Comments on Improvements to the HSR Form Source: PULSE Urges FTC, DOJ to Support Pro-Competitive Life Sciences Collaborations and M&A - Partnership for the U.S. Life Science Ecosystem (PULSE)