> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Senate Amendment Seeks to Prevent Generic Drug Delays
- URL: https://www.fdaweb.com/senate-amendment-seeks-to-prevent-generic-drug-delays/
- Published: 2016-12-06T12:00:00.000Z
- Updated: 2026-09-14T21:52:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137499

As the Senate prepares for a floor vote Wednesday (12/7) on the 21st Century Cures Act, Senate Judiciary Committee members led by ranking member **Patrick Leahy** (D-VT) have introduced a bipartisan amendment to prevent pharmaceutical companies blocking cheaper generic alternatives from entering the marketplace. The Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act was originally [introduced](https://www.leahy.senate.gov/press/leahy-leads-bipartisan-intro-of-bill-to-tackle-rising-rx-drug-prices?ref=fdaweb.com) in June by Leahy, chairman **Chuck Grassley** (R-IA), and senators **Amy Klobuchar** (D-MN and **Mike Lee** (R-UT), leaders of the Subcommittee on *Antitrust*, Competition Policy and Consumer Rights. The amendment encourages name brand drug manufacturers to share product samples with generic companies. It further “ensures patient safety by allowing the FDA to require additional information before approving a request for samples of high risk drugs,” a [release says](https://www.leahy.senate.gov/press/under-leahys-initiative-bipartisan-leaders-of-the-senate-judiciary-committee-urge-senators-to-address-rising-prescription-drug-prices?ref=fdaweb.com). “The original bill and the modified amendment also help generic drug companies develop safety protocols to bring their products to market. Finally, the amendment allows the FDA to more easily approve separate safety protocols.” Text of amendment can be found [here](https://www.leahy.senate.gov/imo/media/doc/BOM16654.pdf?ref=fdaweb.com).