When a novel product (whether it is a medical device, drug, or biologic) seeks FDA approval, it can go to panel. A panel involves a certain group of experts under each FDA center that will meet to approve the PMA and recommend the device market release to the FDA. The panel can heavily influence the release of novel products to the market. Therefore, the individuals on this committee should be carefully chosen. What experience and skill sets do you believe should be requirements to become a member? Would a member with a background in quality control and/or quality assurance provide valuable insight in a FDA advisory panel? Should this type of background be a requirement?
When assembling an expert panel to evaluate a product for FDA endorsement, diversity and a broad range of expertise are paramount to guarantee a comprehensive evaluation of all product facets. This includes its safety, efficacy, manufacturing standards, and overall quality. Key members should encompass medical professionals familiar with the conditions addressed by the product, offering insights into the clinical relevance of trial outcomes, potential adverse effects, and the overarching profile balancing benefits against risks. Additionally, experts well-versed in clinical trial design and interpretation are invaluable for making sense of the data in context. Understanding the statistical significance and ensuring the application of correct methodologies calls for statistical experts, while products with an engineering angle benefit from insights by biomedical engineers or those in related domains. When dealing with pharmaceuticals and biologics, a solid grounding in pharmacology or biotechnology can shed light on long-term effects, interactions, and mechanisms. Quality assurance and control professionals, equipped with an understanding of manufacturing processes and ensuring consistent product quality, add another layer of critical oversight. Their involvement can be instrumental in verifying that the product adheres to good manufacturing practices and that robust systems are in place to address quality-related issues. Ethical experts are also a crucial inclusion, addressing concerns particularly relevant in trials that may pose significant risks or involve vulnerable groups. While having expertise in quality assurance is undeniably beneficial, making it a mandatory requirement might hinder the panel's assembly. It might be more effective to ensure that quality assurance expertise is present when it is particularly relevant to the product in question.
I agree that FDA advisory committees must consist of a variety of experts; yet, I would also add that manufacturing and regulatory considerations are just as vital as clinical and statistical knowledge. Regarding necessary knowledge, members should not only have a strong background in the particular field related to the product (medical devices, drugs, or biologics) but also a thorough awareness of the regulatory environment and manufacturing techniques to guarantee the safety, efficacy, and compliance of the product.
With regard to a background in quality control (QC) and/or quality assurance (QA), I believe this experience would offer insightful panel analysis. Assessing whether the manufacturing process satisfies good manufacturing principles (GMP) and guaranteeing that the product can be consistently produced to the same standard would be tasks for a QA expert. This might stop possible post-market problems such manufacturing flaws causing product recalls.
Though having a QC/QA specialist on the panel will improve the assessment of the safety and quality of a product, I do not think it should be a strict need for every product. Including QC/QA knowledge on panels when assessing products with complicated or innovative production techniques where quality control is a major consideration would be more advantageous.
@fh28 I agree with your perspective on the importance of diversity as well as varied expertise on an FDA expert panel! This is crucial as each member brings a different background to the evaluation, as every side of a product’s safety must be assessed. For instance, including the experts well versed on quality control as well as quality assurance is very valuable since they can guide a team towards successful manufacturing standards and processes. This is overall highly important for ensuring the product is consistent and viable long term. While making a quality assurance expert as a mandatory team member may pose complications in assembling the panel, there is no doubt that their expertise is needed on the team for further success. Along with this, ensuring that the right expertise is present for a given product is important to assess a product’s true safety. For example, a cardiovascular expert should be present when evaluating the safety and efficacy of a heart valve. Given the critical nature of ensuring the right experts for the review of a given product, how can we best determine the priority of choosing experts for an FDA panel?
These are great points. I completely agree that having a diverse panel with a range of expertise is critical for thoroughly evaluating novel products. I think the challenge lies in finding the right balance of skill sets for each specific product being reviewed. For example, products with more complex manufacturing processes would definitely benefit from having QC/QA experts involved to assess long-term viability and consistency. As for determining the priority of experts, it could be helpful if the FDA had a tiered approach, where certain types of expertise like clinical relevance or engineering are always required, and others like QC/QA are included based on the complexity of the product’s design or manufacturing process. This would ensure that the panel is both flexible and comprehensive .
Thank you for your question. It is a very interesting question. I believe that there should be different types of people on the panel.
1. Scientific Expertise: people with relevant scientific expertise in the particular field should be in the panel. It ensures propoer scientific evaluation.
2. Cinicial expertise: clinical experts who use similar products should be in the panel since they can assert how the device will perform in the real world
3.Regulatory experience: they can ensure a tradeoff between innovation as safety.
4. Quality Control and Quality Assurance Experience: They ensure that the product meets rigorous safety, efficacy, and manufacturing standards.
There can be other types of members. However, I mentioned the important person that i believe should be included.
