Final answer:
It is true that in VHA trials of investigational drugs, strict control and drug accountability must be maintained. The FDA ensures safety and efficacy through regulations, which lead to both protected patients and individuals who may suffer from delayed access to potentially life-saving therapies due to the long approval process.
Step-by-step explanation:
For Veterans Health Administration (VHA) trials involving investigational drugs, it is mandatory that all drugs must be carefully controlled and that drug accountability is maintained. This statement is True. During clinical trials, the Food and Drug Administration (FDA) regulates investigational drugs to ensure they are administered in a safe and controlled manner. This includes maintaining strict drug accountability, meaning that there must be accurate tracking and documentation of the investigational drug from the time it arrives at a site until its final disposition. This includes who received it, who administered it, and any remaining quantities at the end of the trial.
Strict medical regulations help protect patients from unsafe or ineffective drugs, but there are also downsides to these regulations. The anonymous losers who suffer from these regulations are often those who need access to potentially life-saving drugs that are stuck in lengthy approval processes. While the FDA's oversight is designed to ensure drug safety and efficacy, it can also delay the availability of important new therapies to patients who need them.