Postmarketing commitments: Turning obligations into opportunities

In today’s pharmaceutical landscape, drug approval marks the beginning rather than the end of a product’s lifecycle.

Postmarketing requirements (PMRs) and post-marketing commitments (PMCs) are essential tools for ensuring that patients maintain timely access to critical therapies, while also addressing ongoing questions about long-term safety and efficacy.

The majority of PMRs and PMCs involve clinical trials that focus on confirming safety and efficacy data. According to U.S. Food and Drug Administration (FDA) reviews of postmarketing activities from 2009 to 2018, most newly approved therapeutics carried at least one PMR or PMC, often covering both approved and potential unapproved uses.

From Fiscal Year (FY) 2017 to FY 2024, the FDA has released annual reports tracking the performance of drug and biologics companies in fulfilling these postmarketing obligations. Interestingly, while the total volume of PMRs and PMCs has remained steady, the number of open and ongoing commitments remains significant and persisted through FY 2024.

Reviewing data from 2017 to 2024, several trends stand out:

Improved completion rates - The percentage of fulfilled PMRs and PMCs has steadily improved, showing increased industry focus on compliance and delivery.

Timeliness remains a challenge - Although simplified annual reporting has helped clarify progress, delays in study completion are still a major issue, underscoring the need for proactive planning and execution.

Data and technology hold promise - Advances in real-world evidence (RWE) and AI-driven analytics are beginning to transform how companies approach postmarketing studies. This is helping to accelerate timelines and improve the quality of patient insights.

Cross-functional collaboration is critical - When regulatory, clinical, market access, and commercial teams align, organizations can meet postmarketing commitments more efficiently without slowing down innovation.

This level of collaboration is where companies often struggle, and where strategic partners like G&L Scientific play a critical role in helping to coordinate complex programs across disciplines, ensuring regulatory compliance, and driving integrated solutions that align with business objectives.

As the regulatory environment evolves and patient expectations grow, postmarketing commitments are more than just check-the-box activities.

They offer unique opportunities to generate real-world evidence, (RWE), build trust with regulators and patients, and differentiate products in a competitive market. Companies that embrace PMRs and PMCs as strategic assets, rather than regulatory burdens, will be better positioned to deliver long-term value.

If your organization is grappling with postmarketing challenges or looking for ways to turn commitments into opportunities, G&L Scientific can help. Our integrated product development and regulatory expertise means we can partner with you at every stage, from strategic planning to operational execution.

Reach out directly or visit www.gandlscientific.com to learn how we can support your regulatory strategy and drive your business forward.

Paul Kuiken is Vice President of Advisory Services at G&L Scientific.