Final answer:
Generic drug substitution should occur unless medically contraindicated, with the brand-name drug being preferred in cases of unique tolerability or efficacy concerns. The FDA's role in ensuring the equivalence of generics was emphasized following a scandal in 1989.
Step-by-step explanation:
Generic drug substitution should always occur unless there is a specific medical or therapeutic reason to prescribe the brand-name drug. For instance, if a patient has a history of side effects with a generic or if the brand-name drug has a unique formulation that is better tolerated, a physician may recommend the name-brand version. Additionally, if there are concerns about the bioequivalence or efficacy of a generic option, a healthcare provider may opt for the brand-name drug. The U.S. Food and Drug Administration (FDA) ensures that generic drugs are therapeutically equivalent to their brand-name counterparts through an Abbreviated New Drug Application (ANDA).
In 1989, a generic drug scandal highlighted the importance of stringent FDA approval processes when allegations of corruption emerged within the FDA concerning the approval of generic drugs. This scandal underscored the need for continued vigilance in the regulation and approval of generic medications to ensure safety and efficacy for the public.