Final answer:
The DEA and FDA are responsible for determining the schedules of new controlled substances, balancing safety with access to treatment. People are protected by this regulation, but there are also drawbacks including delayed access to drugs and high costs for pharmaceutical companies.
Step-by-step explanation:
The authority responsible for determining the schedule of a new controlled substance in the United States is the Drug Enforcement Administration (DEA), in conjunction with the Food and Drug Administration (FDA). When a drug is developed or discovered, it undergoes a rigorous evaluation process to determine its potential for abuse, medical applications, safety, and dependence liability. This assessment is part of a New Drug Application (NDA), and if the DEA and FDA find the drug to pose certain risks or potential for abuse, it may be assigned a specific schedule under the Controlled Substances Act (CSA). The DEA then formalizes this scheduling, which dictates the level of control over the substance's production, distribution, and use. The scheduling process seeks to balance the potential health benefits of the drugs against their potential for abuse and harm.
The winners in this regulatory system are people who are protected from unsafe or ineffective drugs. However, the losers may include patients who experience delayed access to potentially beneficial treatments and the pharmaceutical companies that incur substantial costs and time delays due to the extensive testing and approval process required by the FDA and DEA.