Non-Standard Procedures Employed by FDA Expert Groups
In recent times, concerns have been raised about the FDA's expert panels, which are intended to provide unbiased advice on regulatory decisions. These panels, while not classified as advisory committees, operate in a regulatory grey area.
One of the key issues is the selection process of these panels. Critics argue that the experts chosen may not go through the normal review process, and some question the qualifications of certain figures. The selection of these individuals could potentially be influenced by top agency leadership, leading to concerns about fairness and ethics.
Moreover, some panel members have been found to have undisclosed conflicts of interest. For instance, one speaker on a talc panel had previously served as a paid witness in legal cases related to the topic. Similarly, a new FDA appointee participated in panels shortly after publishing a paper on a specific topic in a fringe journal with ties to COVID-19 skeptics, raising questions about their qualifications and the potential elevation of certain views.
Another point of contention is the transparency of these panels. Under current law, advisory committee meetings must be announced at least 15 days ahead of time, with published materials and open time for public comment. However, the recent expert panels have not adhered to these requirements, causing confusion about their fit within the FDA's structure.
The use of these panels could potentially influence future agency policy, blurring the line between informal discussion and official guidance. This has led some to believe that the gatherings may be skirting the rules that typically guide agency decision-making.
The FDA's credibility is at risk due to these developments. Critics argue that the agency may be using these panels to weaken its own standing as a neutral, science-based body, and to potentially promote pre-set messages.
The FDA has held several expert panel discussions on topics including hormone therapy, SSRIs in pregnancy, talc in consumer products, and infant formula. Panelists at some meetings were observed mentioning that a change in FDA labeling could bring more business to their practices, a fact not noted in their official bios or conflict statements.
It is essential that the FDA's expert panels maintain their integrity and adhere to the strict regulatory frameworks and practices designed to ensure scientific rigor, transparency, and impartiality. This includes following the Federal Advisory Committee Act (FACA), which requires balanced membership, public transparency, and strict conflict of interest rules.
Without more clarity and adherence to these established guidelines, concerns over fairness and ethics in the FDA's panel selection process will likely continue to grow. It is crucial for the FDA to address these concerns and ensure the continued trust and confidence in its decision-making processes.
- The concerns about the FDA's expert panels extend to the health-and-wellness sector, as some panel members have been found to have undisclosed conflicts of interest, such as a speaker on a talc panel who had previously served as a paid witness in legal cases related to the topic.
- The FDA's potential manipulation of its expert panels for policy-and-legislation purposes, such as promoting pre-set messages in medical-conditions discussions, raises questions about the agency's commitment to scientific rigor, transparency, and impartiality.
- The general news media is now focusing on the importance of the FDA maintaining the integrity of its expert panels, as breaches of fairness and ethics in the panel selection process could erode public trust and confidence in the agency's decision-making processes.
