Question

"Which act, also known as Drug Price Competition and Patent Term Restoration Act, was legislated to encourage the manufacture and marketing of less expensive copies of brand-name drugs?"

-Hatch-Waxman Act of 1984
-Prescription Drug Marketing Act of 1987
-Prescription Drug Users Fee Act 1992
-Fair Packaging and Labeling Act of 1966
-Drug Importation Act of 1848

Answer 1

The Hatch-Waxman Act of 1984, also known as the Drug Price Competition and Patent Term Restoration Act, was legislated to facilitate the entry of generic drugs into the market. It achieves a balance between drug innovation and the accessibility of affordable generics while being regulated by the FDA for safety and efficacy.

Step-by-step explanation:

The act that was legislated to encourage the manufacture and marketing of less expensive copies of brand-name drugs is known as the Hatch-Waxman Act of 1984. This act, formally named the Drug Price Competition and Patent Term Restoration Act, made it easier for generic drugs to enter the market by submitting an Abbreviated New Drug Application (ANDA) to the FDA. The Hatch-Waxman Act provided a balance between encouraging innovation in drug development and speeding the availability of lower-priced generic medicines.

Under this act, generic drugs must show they are bioequivalent to the brand-name counterpart to gain approval from the Food and Drug Administration (FDA), which regulates the safety and efficacy of medications sold in the United States. While the regulation of medicines can mean years of testing before a drug reaches the market, protecting consumers from potential harm, it also has implications for high costs and access to medication, indirectly affecting those who could benefit from earlier access to lower-cost generics.