McKinney POV

Several Healthcare Marketing sources recently reported on the shakeup at the FDAʼs OPDP offices

The new Kennedy DHHS administration delivered an unexpected wave of firings, hitting OPDP staff especially hard. The abrupt changes left stakeholders who rely on the office uncertain about their next steps and what the future holds.

Uncertain Fallout for Pharma

The full impact of the OPDP shakeup remains unclear. Firings have cut across all
departments—policy, analysis, legal, project management, and social science. The OPDP website hasnʼt been updated since January 5, 2025 and no official statement has been issued. Without replacement policies in place, pharma companies are navigating in the dark.

A Volatile Federal Landscape

These changes reflect broader turbulence across the federal government, which makes outcomes difficult to predict. Executive orders and judicial rulings could further alter the situation at OPDP suddenly and significantly. The situation remains highly fluid and unpredictable.

Slower Reviews, Less Consistency

The staff cuts will likely result in longer review times and inconsistent reviews. Inexperienced reviewers may now be expected to handle complex submissions that normally would be beyond their experience level. While some believe this signals a move toward limiting DTC advertising, no such policy has been confirmed. Recent departures of senior OPDP officials have fueled speculation of major changes—especially if incoming leaders take a stricter stance on DTC communications.

Internal Review Teams May Choose Caution

The loss of OPDP guidance could prompt internal MLR teams to become even more conservative and risk-avoidant. Companies rely on OPDP for validation of their campaigns. Without this essential feedback to guide them, companies may grow wary of regulatory backlash, leading MLR to adopt stricter, more conservative stances. This could stifle creative risk-taking—not because of formal OPDP action, but because of how companies react to the uncertainty

Action Steps for Marketing Teams

1. Align internally as a team – Marketing teams should open a dialogue with their internal MLR/PRC counterparts to understand where they stand and how they plan to
respond—particularly what that means for upcoming campaigns. We encourage you to
include your Ad Agency in these discussions who have the benefit of working with multiple clients and multiple campaigns that may lead to new perspectives.

2. Stay agile – In this moment of regulatory uncertainty, the smartest move is to stay nimble and proactive. Track industry news but be ready for more change. Make decisions based on the information you have today, even though it may change tomorrow.

3. Donʼt assume anything – Ultimately, regulatory review in the MLR/PRC process is about balancing risks. More limited resources at OPDP could possibly translate into less risk overall, and statements once considered high risk may no longer be so. However, a leaner OPDP team could be more conservative because they have less resources to dig into the claims being made. Donʼt assume risk increases or decreases with these changes at OPDP. This might be an opportunity to explore some new claims/messages and see what kind of reaction is received from OPDP, thus resetting your MLR/PRC baseline. Of course, that is provided that these statements are not misleading or untruthful, and that reassessment of these statements is done with complete transparency.

4. Track your rivals – Keep a close watch on how competitors are adapting; their behavior may offer early signals of emerging norms.

5. Stay true to your brand value proposition – Most importantly, donʼt let ambiguity become a barrier to creativity that highlights the best of your brand. These changes may slow reviews or introduce new challenges, but they do not yet redefine the rules. Until they do, letʼs continue to push for bold, strategic work that meets the moment.

If you have any questions or want to discuss please feel free to reach out to
Michael.McNamara@McKinney.com or Darcy.McCarthy@McKinney.com

References
1. https://www.mmm-online.com/news/rfk-jr-hhs-gutted-opdp-impact-on-pharma-advertising/?utm_source=marketing&utm_medium=email&utm_campaign=NWLTR_MMM_AM_040825_GF&hmEmail=&
sha256email=7f186b0232478f63b8e99039afba38b57663b01d08bed56704356a4cc08c9289&elqT
rack=True. Accessed April 11, 2025.
2. https://www.nrdc.org/stories/what-happens-if-supreme-court-ends-chevron-deference. Accessed
April 11, 2025.