Availability of EAPs for Terminally Ill Patients
Terminally ill patients are often deprived access to experimental drugs as a result of federal government policies and regulations. Without access to these drugs, patients lose the opportunity to improve their current medical condition. Members of the scientific community also lose the opportunity to collect additional data that could possibly lead to scientific breakthroughs. While they are the ones affected the most, terminally ill patients are not the only ones lacking access to experimental drugs. Chronically ill patients could also benefit from easier access. The current government regulations need to be re-examined to determine whether they are inhibiting research and the medical…show more content… Physicians must prove that there is no other comparable or satisfactory alternative in order to diagnose, monitor, or treat their patient’s condition or disease. They must also conclude that the potential risk of the product is not greater than the risk of the disease or condition (Expanded Access 1). The FDA must also determine that here have been enough tests done already to provide sufficient evidence as to the safety and effectiveness of the product and its use in the case (Expanded Access 1). In addition, the FDA must also be certain that by providing this product to patients outside of the clinical trial it will not interfere with the clinical trial, and the FDA acceptance of the drug (Expanded Access 1). Another requirement is that the company developing the pharmaceutical product, or the clinical investigator, submits a treatment plan (clinical protocol) for the patient, which must follow the FDA’s regulations for INDs (Investigational New Drug) or IDEs (Investigational Device Exemption Application), which describe the use of the investigational product (Expanded Access 1). Pharmaceutical companies must also submit a draft of the Data Development Plan (Expedited Access Pathway Program).
EAPs are the use of medicinal products outside of clinical trials before the FDA has approved them for public use. It is important to note that EAPs are voluntary programs (Expedited Access Pathway Program 1). These programs are only for medical products that