A New Coalition Emerges

Introducing PULSE: Partnership for the US Life Science Ecosystem

The newly established Partnership for the US Life Science Ecosystem, or PULSE, officially launched with 31 founding members. PULSE aims to raise awareness about the importance of mergers and acquisitions (M&A) within the life sciences sector in response to the Federal Trade Commission (FTC) and the Justice Department’s efforts to enhance merger guidelines and revise the disclosure regime.

The Vital Role of M&A in the Life Sciences Industry

A press release by the coalition emphasizes the critical role M&A plays in the life sciences industry. M&A transactions provide burgeoning competitors with opportunities for expansion beyond internal development. Additionally, these deals enhance company efficiency, expediting new drug development while reducing costs.

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Concerns Over Changes to Merger Disclosure Documents

The formation of this coalition underscores the broader criticism surrounding the changes made by regulatory agencies to the standard merger disclosure documents, known as Hart-Scott-Rodino (HSR) forms, and the merger guidelines.

Divided Opinions on Regulatory Changes

While some attorneys, companies, and private equity firms argue that these changes represent an overreach, regulatory agencies defend their stance, asserting that a robust response is essential to counteract extensive economic consolidation, previous oversight failures, and evolving dealmaking strategies. This includes industry roll-ups, where companies pursue a series of small acquisitions that, individually, do not raise anticompetitive concerns but can collectively consolidate an industry.

PULSE’s Concerns

In their release, PULSE states, “If continued, the FTC’s flawed approach to M&A review and enforcement would undermine the dynamic ecosystem responsible for many of the world’s most innovative and important treatments.” They argue that deterring pro-innovation M&A could disrupt the numerous complementary relationships within the life sciences ecosystem, potentially stalling treatments and cures for patients while jeopardizing jobs, wages, and economic growth nationwide.

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Recent Regulatory Actions in the Life Sciences Industry

The FTC has recently taken action against dealmaking and alleged illegal conduct within the life sciences and pharmaceutical sectors. For instance, it filed a lawsuit against Amgen in September concerning its $27.8 billion merger with Horizon Therapeutics Plc over concerns about bundling two of Horizon’s leading drugs. Additionally, the agency initiated legal action against US Anesthesia Partners and its private equity parent, Welsh Carson Anderson & Stowe LP, alleging a scheme to monopolize the Texas anesthesiology market through roll-ups.

Importance of M&A for Long-term Success

PULSE emphasizes that the lengthy development timelines and high costs in the life sciences sector underscore the significance of M&A for long-term success. On average, it takes more than a decade and $2.6 billion to develop and bring a new medicine to patients. According to research published in the Journal of Health Economics, only 12% of new drugs entering clinical trials receive Food and Drug Administration approval, as the Congressional Budget Office reported.

Advocating for the Value of Dealmaking

Members of the coalition plan to advocate for the value of dealmaking by showcasing new research and analysis on the potential effects of proposed changes to merger guidelines and HSR forms. These forms are submitted by merging parties to the federal government to facilitate the review of deals. The coalition also intends to host webinars and briefings and will directly engage with regulatory agencies regarding future changes.

By forming PULSE, these life sciences organizations and trade associations aim to voice their concerns and ensure that the value of M&A in the industry remains recognized and protected.

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