Conference on Transparency and HCP Interaction by Informa Connect
The Transparency & HCP Engagement Conference, hosted by Informa Connect, brought together Pharma and MedTech visionaries this August. During the event, Amanda Masselam Strachan and Lauren Kootman, Principal Assistant Deputy Chief of the DOJ's Corporate Enforcement & Compliance Unit, Fraud Section, discussed the regulatory landscape and emerging trends for the life sciences industry.
The chat offered an understanding of the latest guidance and expectations for effective compliance programs. The session, titled "Enforcement Update - Examining Today's Regulatory Landscape and Emerging Trends," took place on Tuesday, August 12, running from 11:15am to 12:00pm.
The discussion focused on HCP engagement, compliance monitoring, and data reporting and governance. Masselam Strachan and Kootman highlighted several key themes:
- Increasing regulatory scrutiny and complexity: Validation teams in life sciences face heightened challenges around audit readiness and compliance burdens due to evolving global regulatory requirements. This has made maintaining a constant state of audit preparedness critical, despite many teams being leaner and experiencing increased workloads.
- Heightened state-level regulatory oversight of industry structures and transactions: New laws in states like Oregon, Massachusetts, and California are imposing significant restrictions on common investment and operational models, such as Management Services Organizations (MSOs), impacting deal approvals and operational control in healthcare entities.
- FDA initiatives to accelerate domestic manufacturing: The FDA's new PreCheck program aims to facilitate early and frequent interaction with manufacturers on facility design and construction to speed up domestic drug manufacturing, reflecting a regulatory push to enhance manufacturing agility and oversight.
- Robust M&A activity amid regulatory and antitrust developments: Despite regulatory pressures, the life sciences sector has seen an acceleration in mergers and acquisitions in 2025, with major transactions shaping strategic and regulatory considerations for companies.
- Market and operational challenges: The sector faces slackening demand, supply pressures, cautious funding environments, and real estate and workforce adjustments, although domestic biomanufacturing investments signal long-term growth potential.
Together, these points outline a regulatory environment that is more complex and demanding, requiring life sciences companies to be more audit-ready, agile in manufacturing, mindful of evolving state regulations affecting ownership and operations, and strategic in transactional activities. Emerging trends emphasize digitalization, leaner but higher-pressure validation teams, increased state regulatory scrutiny on healthcare investments and MSOs, and a proactive FDA role to expedite manufacturing innovation.
These insights reflect the broad themes discussed by Masselam Strachan and Kootman, positioning companies to navigate 2025's evolving landscape effectively. The fireside chat on August 12 also analyzed the current regulatory landscape and recent enforcement actions impacting the life sciences industry.
References:
[1] Increasing regulatory scrutiny and complexity [2] Heightened state-level regulatory oversight of industry structures and transactions [3] FDA initiatives to accelerate domestic manufacturing [4] Robust M&A activity amid regulatory and antitrust developments [5] Market and operational challenges
In the context of the life sciences industry, the increasing regulatory scrutiny and complexity, heightened state-level regulatory oversight of industry structures and transactions, FDA initiatives to accelerate domestic manufacturing, and robust M&A activity amid regulatory and antitrust developments are shaping a technology-driven health-and-wellness landscape, where medical-conditions management and science-based innovations are put under close examination. The fireside chat on August 12 also analyzed the current regulatory landscape and recent enforcement actions impacting this industry.
