In Uncertain Times, Good Compliance and Quality Communication Habits Can Offer a Port in the Storm

The ongoing DOGE-led reductions to the federal workforce and recent sweeping policy changes have spawned many questions for compliance officers and quality managers in FDA-regulated companies. How will the cuts at FDA impact inspections and enforcement? Will there be a heightened appetite for mergers and acquisitions in the space? How will the imposition of tariffs and a burgeoning trade war affect domestic drug production and companies’ supply chain demands? Does the stand down of FCPA enforcement mean that it’s okay to bribe foreign officials now?

With all the change we are witnessing in the American model of regulation and governance, it might be tempting to ask if we are suddenly living in a post-compliance world.

The answer to that is still “no,” the current state of world and governmental events notwithstanding. For one thing, the possible answers to our rhetorical questions above are not final yet and will take years to sort out. Also, to be sure, quality still matters in the drug and device industries. M&A rises and falls on due diligence along with other factors like market conditions and growth opportunities, so compliance and quality are vital links in any deal chain. Trusting suppliers is still fundamental to any drug or device manufacturer. And the Department of Justice will still pursue viable civil and criminal cases, if not under the FCPA then under other statutes like the False Claims Act, Title 18 fraud and conspiracy, and even RICO.

So, yes, compliance and quality still matter, a lot. And they still matter to companies looking for certainty and security in turbulent times. Organizations should want to instill good habits in their employees to make compliance easy and rewarding, looking both internally and externally.

Communication of an organization’s compliance culture is key because a significant disparity often exists between how C-suite executives and lower-level employees perceive it. A 2025 study reported by Radical Compliance found that while senior management often believes in the robustness of their ethical culture, employees at other levels do not.

Some communication techniques may be better at emphasizing the importances of compliance and quality, to make the associated good habits easy, and to ensure that a company’s program is well designed, is applied earnestly and in good faith, and works in actual practice.

Clarity of purpose is a good place to start. If a compliance or quality program exists only as bargaining chip to use with regulators, that’s not a formula to instill good habits. But company leaders must look to their own values and understand and embrace them before they can communicate them on to the rest of management and down the chain. In other words, communicating specific ideas and concerns that apply to a specific business model are more likely to be effective than trying to improvise about vague or inconsistent issues.

Tailored messaging is vital, because at no company is “the chain” comprised of people that think and act uniformly. They have different duties, different concerns, and will react to different triggers. A one-size-fits all approach to communication of important principles is therefore less likely to be successful.

Dialogue is also key. It can be difficult to maintain interest during one-sided, one way instruction. Engagement with employees makes feedback—and thus interest—more likely and consistent. And, frankly, it is a useful tool to manage potential whistleblowers by addressing concerns before they mushroom. One of the most crucial aspects of compliance communication is creating an open line, both up and down the chain.

Finally, effective compliance and quality communication is not a one-off event. It’s on ongoing conversation aided by effective, recurrent training that serves as a continuous reminder and puts good habits within easy reach. Again, it’s also a useful tool to manage problems when they do arise. It’s hard to communicate in a crisis, but when one hits, the ongoing conversation should ideally lead to remedies that are easier to implement.

Bad compliance and quality habits are like the cookies in the cupboard you might be trying to cut back on: if you never introduce them into your home, plant, or management offices, the risks they pose go down. Good habits that include effective, thoughtful communications provide clarity, understanding, and by hopefully avoiding crises, profitability. But the conversation probably works best when it goes from the C-suite to the shop floor and back.

HPM Counsel John W.M. Claud is the former Assistant Director of the Corporate Compliance and Policy Unit at the U.S. Department of Justice’s Consumer Protection Branch. These are condensed thoughts from his speech “Communicating Regulatory Impact to Your Organization: Advanced Procedures for Compliance Success,” which he delivered at the 2025 Q1 Productions Life Science Regulatory Intelligence & Strategy Conference.