In the realm of policymaking, the relationship between politicians and industry professionals can be complex. While both parties play a crucial role in shaping legislation, it is not uncommon for them to have different goals and priorities. This disparity can often lead to contrasting outcomes when bills are passed. The recent passing of Clinical Trial Diversity and Modernization provides an opportunity to analyze this complicated relationship between political expectations and an industry which follows established processes rather than push boundaries.Politicians are elected to represent their constituents and uphold their interests. This means that their primary goal is often to secure support and gain popularity among their voters. The spotlight COVID brought to the research industry brough old industry conversations to the general public. A conversation research professionals had for decades, how to diversify clinical trials, became a topic of public opinion, political ideologies, and was added to proposing and passing bills. Politicians aimed to address the concerns of the broader public and fulfill their campaign promises.
It’s important to ask; Are goals of the politicians aligned with the realities of the pharma industry? Does the FDA have the resources to drive change in the pharmaceutical/biotech/medical device industries?
It is a fact, diversity is a huge barrier for clinical research success and many industry leaders, such as Merck, have been driving complex conversations and setting internal procedures aimed at diversification.
However, do the goals of the politicians align with the goals of the pharma industry? Are Politicians and Researchers speaking the same language when saying, “diversify”?Industry professionals possess the expertise and knowledge of the complex FDA approval process. They understand the intricacies and nuances that can affect the practical implementation of government policies. Their primary goal is to ensure that legislation supports the growth, sustainability, and competitiveness of their industries. Industry professionals often advocate for policies that promote innovation, economic growth, and job creation while protecting their specific interests.The differing goals of politicians and industry professionals can create a wide variety of conflicts of interests. While politicians strive to address the concerns of the public, industry professionals may worry about the potential impact of regulations on their businesses, trade, or profits. This can result in heated debates, compromises, and amendments that may dilute or alter the original intent of the legislation.When speaking about diversity the implementation of policies can become challenging. The new reforms bundled under Title III, the Food and Drug Omnibus Reform Act of 2022, or FDORA. Chapter 1 of subtitle F, Clinical Trial Diversity and Modernization, amends the Federal Food, Drug, and Cosmetic Act to require drug and device sponsors to submit diversity plans. In order for this to be a success, the expectations of how the industry will articulate goals for increasing enrollment of historically underrepresented populations, need to be clear. FDORA allows for a waiver which permits FDA to waive the diversity action plan requirement at its own discretion or upon sponsor request. Could this waiver process lead to cutting corners or ineffective FDA guidance?
Misalignment between the intended outcomes and the practical implications of legislation can hinder its effectiveness or lead to unintended consequences. It is crucial to strike a delicate balance between the interests of both politicians and industry professionals to ensure that policies are not only practical but also address the needs of the public. Building up to FDORA there were many public debates, discussions, and outcries for equity… After FDORA passed I’ve seen much less… Moving into 2024 Diversity Plans are required for pivotal trials and Phase 3 studies, will we see an uptick in these discussions again?
I hope we continue these important discussions. Recognizing and bridging the gap between political public need and industry leadership is crucial to ensure effective policy implementation that addresses the needs of industry diversification.
Keep an eye on my LinkedIn Feed as I work with collaborators to schedule thoughtful discussions on diversity in 2024. Through open dialogue, collaboration, and a shared commitment to the common good, policymakers and industry professionals can collaborate on solutions that uphold society's needs and the industry’s economic prosperity.
Agu, S., Church, R., & Wilson, B. (2023, January 11). U.S. Congress embraces FDA’s approach to clinical trial diversity in new omnibus legislation. Hogan Lovells Engage. https://www.engage.hoganlovells.com/knowledgeservices/news/us-congress-embraces-fdas-approach-to-clinical-trial-diversity-in-new-omnibus-legislation/