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# Bill to Streamline Generic Drug Approvals
- URL: https://www.fdaweb.com/bill-to-streamline-generic-drug-approvals/
- Published: 2022-06-01T12:00:00.000Z
- Updated: 2026-09-14T17:47:06.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151941

Sens. **Maggie Hassan** (D-NH) and **Rand Paul** (R-KY) have introduced legislation (S. 4338) they say will streamline the process for approving generic drugs. A [statement](https://www.hassan.senate.gov/news/press-releases/senators-hassan-paul-introduce-bill-to-lower-medication-costs-by-streamlining-generic-drug-approval-process?ref=fdaweb.com) says companion legislation was introduced in the House by Rep. **Annie Kuster** (D-NH) earlier this year.

Hassan says the bill would require FDA to more clearly identify the specific differences between a generic and a branded drug, thereby streamlining the approval process. Currently, she says, the agency requires generic drug manufacturers to demonstrate that they have the same active and inactive ingredients in the same concentration as the reference-listed drug. However, she says, when a generic drug contains the wrong amount of inactive ingredient, FDA cannot disclose the exact error, forcing manufacturers to engage in an “often lengthy guessing game to reach the right balance.”