What primary change did the Waxman Hatch Amendment facilitate regarding generic drugs?

The Waxman-Hatch Amendment primarily facilitated the approval process for generic drugs by requiring proof of bioequivalence rather than requiring the full range of clinical trials that brand-name drugs must undergo. This was significant because bioequivalence studies demonstrate that the generic product delivers the same amount of active ingredient in the same timeframe as the original brand-name drug, ensuring therapeutic effectiveness and safety without the need for extensive clinical trials.

By streamlining the approval process, the amendment aimed to encourage the marketing of generic drugs, thereby increasing competition in the pharmaceutical market and reducing drug costs for consumers. This change has had a lasting impact on the availability and affordability of medications in the United States, while maintaining necessary safety and efficacy standards.