RFK Jr’s Potential Impact on the CRO Industry

Written By Evan Picard

It appears likely that Robert F. Kennedy Jr. will become the new Secretary of Health and Human Services under President Trump. He is viewed as a polarizing nominee, mainly for his outspoken stance on health-related issues, ranging from fluoride in water to the impacts of vaccines on health.

Assuming RFK Jr. gets through congress, he will begin to launch his policies and stances that will impact the FDA, the pharmaceutical industry, and contract research organizations (CROs). Kennedy has been critical of the FDA, arguing that the agency is too heavily influenced by pharmaceutical companies, undermining its ability to regulate drugs effectively. He has called for reforms to ensure that the FDA's decisions prioritize public health rather than corporate interests, advocating for greater transparency and independence in the drug approval process. A specific example of what RFK Jr. finds as a conflict of interest: USA Today reports “In 2024, $3.3 billion, almost 46% of the FDA’s $7.2 billion budget, came from so-called "user fees," or payments made by pharmaceutical and medical device manufacturers to fund the FDA staff resources needed to review their products quickly, conduct inspections, and ensure the safety of clinical trials”.

Kennedy's critique of the pharmaceutical industry extends to his concerns over clinical trials and the practices of pharmaceutical companies. He believes that the industry often prioritizes profits over patient safety, claiming the existence of suppression of negative data from clinical trials to make drugs appear safer or more effective than they truly are. RFK Jr. advocates for reimagined regulations that would ensure clinical trials are independent, transparent, and free from corporate influence. His calls for reform align with his broader campaign, claiming the need to improve the credibility of both the FDA and the pharmaceutical industry.

So where does this take the CRO industry? There are areas that will clearly become more of a focus in the future:

  • OTC efficacy verification & OMORs

    • Drugs that are currently available to the general public need to prove they are actually effective. And new requests for OTC go through the OMORs process, which will likely get even more scrutiny under RFK Jr.

      • We have seen this already in practice with the FDA proposing the removal of oral phenylephrine, a common ingredient in many popular over-the-counter decongestants, from the market as they state it is not effective when taken orally or in a pill form.

  • Risk Evaluation and Monitoring Strategies (REMS)

    • Risk monitoring and patient safety strategies, both during trials and post-NDA, are surely going to see an increase in requirement and use. Pharma companies would be well served to integrate REMS into their trials proactively, as proof of strategies utilized to ensure the measurement & monitoring of patient safety will likely increase when they are going through the NDA process.

  • Data Management

    • The need to alleviate RFK Jr’s concerns related to clarity of data & full data transparency will be very important. There are numerous strategies that can be integrated into trial & protocol designs, with the CRO needing to ensure they can deliver high-quality data management.

We will know much more in the upcoming weeks and months, but for now we can see ahead to some likely areas RFK Jr will want to influence quickly and materially. CROs have had to adapt to market changes in the past, and CROs will continue to be amendable to what is required to get patients effective drugs safely and expeditiously.

Helpful Articles:

  1. USA Today. (2024). “RFK Jr. vow to purge FDA sets up collision with Big Pharma”. USA Today.

  2. NPR. (2023). "RFK Jr. Discusses Concerns Over Vaccine Safety and Government Regulation". NPR Interview.

  3. The Defender. (2021). "RFK Jr. and His Campaign for Medical Transparency". Children's Health Defense.

  4. Kennedy, R. F. Jr. (2021). Vaccines, Autism, and the FDA: A Long History of Concerns. Robert F. Kennedy Jr. website.

  5. The Guardian. (2021). "Robert F. Kennedy Jr.'s Criticism of Big Pharma: A Movement for Reform". The Guardian.

Evan Picard