Emerging trends shaping pharmaceutical compliance in 2025

Proactive compliance within reimbursement hubs, strategic navigation of data purchases, and medical and commercial interactions are among the rising trends in pharmaceutical compliance this year.

In a recent webinar, “Pharmaceutical Compliance: Emerging Trends & Best Practices for 2025” webinar, hosted by the Pharmaceutical Compliance Congress in March, a group of compliance experts discussed the latest movements in the industry, offering insights and strategies to implement. Here are some of the emerging trends.

Compliance’s role in reimbursement hubs

Panelists stressed the importance of involving compliance and legal teams early when building reimbursement hub programs, an approach that is crucial for effective risk management.

“I think that really stems from the broad range of services that companies may consider having as part of their hub, depending on what access challenges their product might face,” David Ryan, senior vice president, legal and chief compliance officer, Ardelyx, said. Reimbursement hubs often include services like patient onboarding, benefits assessment, reimbursement support, and adherence programs. Each service requires tailored compliance strategies, he explained.

“It’s really important not to be reactive and not to be getting involved in these issues on your back foot so that you can really help the business think about the risk that might be presented and help both mitigate those risks. And also solve some business problems that they might be facing.”

Ryan also emphasized the use of data, and how companies should implement best practices to prevent inappropriate use, especially by commercial teams.

In maintaining compliance within hub activities, Kelly Tope, head of ethics and business integrity governance, operations and risk management, North America and global specialty care, Sanofi, suggests back-end monitoring, such as email monitoring. Various vendors offer specialized services that can analyze company emails and CRM system interactions to identify instances, she added.

Data purchases

When considering data purchases from customers, organizations should implement robust internal practices to ensure legitimacy and compliance, according to panelists.

“What I’ve seen in the industry is that these data purchase agreements are becoming bigger and more frequent, and we want to ensure that there doesn’t appear to be any improper influence or quid pro quo arrangement where we’re buying data from a PBM with the specific purpose of not needing it as much as wanting to gain favor, get good position on a formulary, or you’re working with a medical center, and you're purchasing data again for perhaps not the intended purpose that’s listed in the needs assessment,” Tope said.

To address this, Tope recommended an upfront needs assessment and valuation process, followed by ongoing monitoring of contract compliance. “You want to make sure that you have a genuine need for the data, you have a compliant need, and that the individual purchasing the data or the group is going to stay within those confines,” she said.

Tope said her company uses a third-party service to determine the fair market value for its data portal agreements and data purchase agreements. This helps “fortify our position if we ever had an inquiry as to why we bought the data from one of our customers or PBMs,” she said.

Medical and commercial interactions

According to Catherine Starks, partner at Sidley Austin and moderator of the webinar, medical and commercial interactions have become a rising issue. Traditionally, mature organizations have put a strong divide between commercial and the medical side of their organization, she noted. However, in early stage or pre-commercial companies, the “curtain is not as strong and interactions can become blurred during those pre-approval phases,” she said.

Raan agreed and stated: “The single biggest challenge in this area [medical and communications area], despite the fact that these guardrails have been around in the industry for quite a while, remains a deeply mysterious area for many folks in the business. I think one of the reasons it’s so persistently mysterious is because all of us are appropriately figuring out guardrails and policies that are scoped to our risk profile and our particular situation and that differ from each other.”

Ryan pointed out another reason behind this challenge, aside from the lack of potential consistency, “is that folks do often look at these issues as a sort of black and white, yes or no answer, I can do this, or I can't do this, whereas what’s more important in many contexts is what’s the motivation for this communication?”

Also, companies run up against the concept of limiting communication of scientific information goes so against the grain of how most scientists are trained, he explained.

“If it’s scientific information that’s robust, it must be circulated. It has to be. There’s an obligation to communicate it. But the reality is, in the commercial world, we can’t always communicate that information, or we have to communicate it in a specific way that might be counterintuitive to them,” Ryan said.

Tope suggests a strategy where companies should have a pre-launch playbook that begins days, months, or years before a product launch.

“Before approval is affected, you’re allowed these activities, and you back up from a timeline perspective and explain what may be permissible,” she said. “Then, as with many things in compliance, the risk assessment, guardrails, and training around what’s allowed become important because people may not be in roles where they don’t intuitively know, and they think they’re doing the right thing.”

Learn more about the latest trends in pharmaceutical compliance at our upcoming conference.

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