Groundbreaking Diabetes Drugs and their Approval Process

 by Henry Ball

The U.S. Food and Drug Administration (FDA) plays a pivotal role in ensuring that the drugs we use are safe and effective. This responsibility is especially crucial as the medical field continues to evolve faster and faster, with groundbreaking treatments and technologies. Understanding this process and the FDA's role can provide insight into the extensive development, testing and approval processes before they reach the public.

The journey of a drug from a laboratory to a medicine cabinet is a long and complex one. Initially, after discovery, drugs are tested on small tissue samples and then on animals to provide an idea of their effect on humans. If these tests are successful, the drug is submitted in an Investigational New Drug (IND) application to the FDA. This application contains evidence from laboratory and animal studies, showing the drug's safety and potential for effectiveness. Once the IND is approved, the drug enters clinical trials with humans, conducted in phases in order to progressively evaluate the drug's safety and effectiveness while minimising risk.

The clinical trial phase is vital. Phase 1 trials test the drug on a small group of healthy people without the disease in order to analyse safety and dosage. Phase 2 expands the study to more patients who have the disease to further assess safety and start evaluating effectiveness. Phase 3 then involves a larger group to confirm effectiveness, continue to monitor side effects, and compare the drug to commonly used treatments. As the placebo effect can affect the validity of studies testing the effectiveness of drugs, most trials are done as either double or single-blind trials. Double blind trials being where both the doctor and the patient do not know whether they are receiving the placebo or the new drug, and single blind being where only the patient does not know. In addition to this, so as to not unethically deprive test subjects of treatment, often the control group are given a drug in current use so that patients can be sure that they will receive at least some form of treatment.

If a drug passes these phases, the manufacturer submits a New Drug Application (NDA) to the FDA for final approval. After this, the drug is continually monitored s in Phase 4 to gauge data on its effectiveness and side effects on a larger scale

One recent example of a drug in the early stages of testing is in the field of diabetes treatment. An oral nanotherapeutic form of insulin has been developed, offering a potential, less invasive, alternative to insulin injections for diabetes patients. This innovation could therefore significantly improve the quality of life for those managing diabetes​​.

In conclusion, the FDA's role in drug approval and monitoring is a critical, and often underappreciated, role in the healthcare system. It ensures that the medicines we rely on are not only effective but also safe. It also works in conjunction with organisations such as NICE who decide whether drugs which have gone through the FDA’s approval process are cost-effective and beneficial enough to be used by the NHS, however, that is another process in itself.