2022 Life Sciences Regulatory Outlook (2023)

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In the face of rapidly evolving regulatory and marketplace demands, compliance teams are under constant pressure to do more with less, requiring a fundamental shift that involves the use of technological accelerators. Once these new technologies are up and running, they can not only help drive efficiency and effectiveness, but also help improve a compliance organization’s ability to protect its business and deliver measurable value.

Such transformative technologies include robotic process automation, natural language processing and generation, predictive analytics, and artificial intelligence and machine learning. Read our full report to learn how these technologies can be (and already have been) used to help modernize and enhance compliance monitoring procedures across the industry.

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Business interactions with health care professionals continue to receive close scrutiny from regulators, legislators, and the media. And as more of these interactions and fee-for-services arrangements go virtual—a trend accelerated by the COVID-19 pandemic—health care companies will likely need to make additional adjustments to remain compliant with life sciences regulations.

In addition to potential violations of laws like the Anti-Kickback Statute and regulations like the Physician Payments Sunshine Act, life sciences companies should evaluate speaker programs, fair market value, and even meals. Download the full PDF to learn what regulators might be looking for.

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As with many aspects of the health care system, COVID-19 has pushed the limits of existing patient support programs (PSP) and created increased demand and need, triggering a shift in how patients become aware of and engage with them, as well as a shift in reimbursement, access, and adherence services.

While most life sciences manufacturers have robust third-party risk management programs across their businesses, in many cases, they have not been applied to PSP providers. Many life sciences companies outsource their PSPs to third-party vendors that provide a wide range of services. But when a third party is engaged, new risks are introduced. Read our full report to learn how applying advanced analytics in third-party risk audits could help reduce risk exposure, offer compliance insights, and generate business value.

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The pharmaceutical regulatory compliance environment surrounding drug pricing has always been complex and continues to grow and change. Many life sciences companies are now realizing the dire need for collaboration and coordination across their commercial, compliance, and regulatory organizations to develop sophisticated technology and operational solutions capable of supporting new pricing strategies while meeting ever-changing regulatory compliance requirements.

As life sciences companies and commercial and government payors increasingly implement innovative strategies that shift the focus from volume to value, read our full report to learn more about innovative contracting, 340B Program trends, and continuing regulatory activity related to drug pricing.

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More and more states are taking it upon themselves to curb drug price increases and improve drug price transparency. This trend has gained significant momentum and is likely to continue in the years ahead. As additional states introduce and pass legislation related to price transparency, it will be important for manufacturers to understand the implications for their current and future business.

Read our full report to learn more about upcoming state price transparency requirements, how to prepare for them, and how to turn them into strategic opportunities for new synergies and companywide benefits that span related functions.

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