Final answer:
Sotret (isotretinoin) is part of the FDA's restricted status programs due to its serious side effects. The general public benefits from the FDA's safety regulations, but the delayed drug access for patients and the struggles of smaller pharmaceutical companies represent the 'anonymous losers' of the system.
Step-by-step explanation:
The question relates to the Food and Drug Administration (FDA) and its role in regulating medications, particularly around the strict controls placed on certain drugs due to their potential adverse effects. When considering which drugs are part of FDA's restricted status programs, Sotret is the correct answer. Sotret, a brand name for isotretinoin and formerly known as Accutane, is part of the FDA's iPledge program due to its serious side effects, especially the risk of birth defects if taken during pregnancy.
Regarding the broader discussion of FDA's impact, the 'winners' in the FDA's regulatory system are the general public who are protected from harmful medications. However, the more 'anonymous losers' in the system could be those patients who require treatment but face delays or lack access to potentially beneficial drugs due to the long and rigorous process of drug approval, as well as smaller pharmaceutical companies that struggle with the financial and logistical demands of the FDA approval process.