Final answer:
A decision to sell pharmaceuticals without FDA approval is an illegal action. The FDA ensures the safety and efficacy of drugs, with the public benefiting from this regulation. However, patients needing urgent access to new treatments may suffer due to the lengthy approval process.
Step-by-step explanation:
A decision to sell pharmaceuticals that have not been cleared with the Federal Drug Administration (FDA) is an example of a illegal action. The FDA is responsible for protecting public health by ensuring the safety, efficacy, and security of drugs, biological products, and medical devices. Pharmaceutical companies that sell drugs without FDA approval are violating federal laws, which can lead to fines and other legal penalties. This is a clear cut legal issue, as the sale of unapproved drugs compromises patient safety and undermines the regulatory framework established to protect the public.
The FDA's regulatory process is designed to prevent harm from unsafe drugs, with the general public being the winners in this scenario because they are shielded from potentially dangerous medications. The more anonymous losers in this system could be those patients who suffer from diseases for which treatment options are limited and would benefit from accelerated access to new therapies. Additionally, there is a concern that the high cost and long duration of the FDA's approval process can limit the availability of drugs for patients and reduce incentives for pharmaceutical companies to develop new drugs, particularly those that may not be highly profitable.