Which act addresses drug pricing and affordability issues?

The Drug Price Competition and Patent Term Restoration Act is significant because it aims to make medications more affordable while maintaining proper patent protections for drug manufacturers. This act, also known as the Hatch-Waxman Act, was established to encourage the development of generic drugs. By doing so, it allows generic drugs to enter the market more easily by providing a streamlined approval process. This ultimately helps to lower drug prices for consumers by increasing competition.

The importance of this act is further highlighted in the context of drug pricing and affordability, which are pressing concerns in healthcare; it balances the original pharmaceutical companies' interests with public access to medications. This act enhances accessibility to effective therapies at lower costs, addressing the financial burdens associated with prescription medications.

In contrast, the Controlled Substances Act primarily regulates the manufacture and distribution of controlled substances. The Food, Drug, and Cosmetic Act focuses on the safety and efficacy of drugs and food products, while the Prescription Drug User Fee Act pertains to the FDA's ability to collect fees for drug applications, rather than directly addressing pricing and affordability issues.