Pharmaceutical Regulatory Affairs: Open Access

The American Gastroenterological Association recently published an article, entitled Probiotics and the Microbiome: How Can We Help Patients Make Sense of Probiotics? Detailing their plans to offer a seal service for companies looking to substantiate the evidence behind their probiotic product claims. The paper discussed how under the Federal Food, Drug, and Cosmetic Act (the Act), dietary supplement and food products can claim to affect the “structure or function” of the body without going through the FDA approval process required for pharmaceuticals to make such a claim. Congress’ decision to treat supplements and foods differently than pharmaceuticals was undoubtedly based on the relative safety of food and supplement products, because structure/function claims do not claim that the product can treat, cure or prevent a disease, and because there are other provisions in the Act and in other laws requiring that such claims be truthful, not misleading, and substantiated. While the article cynically refers to this well-established regulatory framework as an “honor system,” and use it a basis to make the case for a new “seal” program, the fact is it has given consumers access to countless safe, efficacious and affordable products that would not have been available had the manufacturers been required to go through the approval process required for pharmaceuticals.

The world has become obsessed with technology these days to the extent where virtually everyone tends not to know how the same technology could cause harm, but for a few. In the healthcare delivery setting, risk and compliance management are key in not only ensuring the safe application of technology with healthcare delivery, but also provides strategies to effectively manage negative outcomes. Cardio-Pad™, a medical technology solution designed and assembled in Cameroon for reading and monitoring of ECG’s in rural areas of Sub-Saharan Africa, is scrutinised through the lens of risk and compliance management. A good description of the components, and recent upgrades to the functioning of this device, which has received several awards for its contribution in improving the quality of health care delivered to citizens of rural areas in Sub-Saharan Africa is reviewed. A qualitative comparison of the design and functioning of this made-in-Cameroon device, a country, which all through this paper is proven to have little respect or desire to implement international standards regulating the production of devices, is carried out with constant reference to international norms. The results obtained details the various institutions in Cameroon which should normally support the continues development of the Cardio-Pad™. It furthermore reveals details from the view of risk and compliance management perspectives. These small but technical details which to a layman who benefits from the application of this device cannot be seen, until one gets to experience the ugly nature of not paying attention to these details Risk and compliance tools used in managing risks are employed in this paper to shed more light on what befalls this medical technology. The paced method is equally used to show how possible examples of compliance risk, hazard risk, control risk and opportunity risk could be effectively managed within the Cardio-Pad design team lead by Arthur Zang. A chief suggestion of creating a risk and compliance management department within this company is proposed. Certain activities resulting also from the analysis of this device using the paced tool are proposed to help with the continues improvement of this device. The suggestions of this paper about what needs to be done both by the Cardio-Pad™ team and the government of Cameroon through its Ministry of Public Health are used to condition the approval or recommendation of this device to be used internationally.