Which act was designed to promote the availability of generic medications?

The Drug Price Competition and Patent Term Restoration Act of 1984 was specifically designed to increase the availability of generic medications. This act created an abbreviated new drug application (ANDA) process, allowing manufacturers to submit simpler and faster applications to the FDA for the approval of generic drugs. This streamlined process allowed for the approval of generic medications without the need for the applicant to provide the same level of clinical data that is required for brand-name drugs, thus encouraging the production and market entry of generics.

Additionally, the act balanced the interests of both generic manufacturers and brand-name pharmaceutical companies by providing patent term extensions for innovator drugs, allowing them to recoup some of the time lost during the FDA approval process. This dual approach helped ensure that patients and healthcare providers had access to more affordable medication options while still supporting innovation.

The other acts mentioned have distinct focuses. For instance, the Kefauver-Harris Amendment of 1962 primarily enhanced the FDA's authority regarding drug efficacy and safety. The Food and Drug Modernization Act of 1997 modernized certain aspects of the drug approval process, but its main emphasis was not specifically on generics. The Controlled Substances Act regulates the manufacture and distribution of narcotics and other controlled substances, with no direct connection