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# OTC Drug Reform Passes Senate
- URL: https://www.fdaweb.com/otc-drug-reform-passes-senate/
- Published: 2019-12-11T12:00:00.000Z
- Updated: 2026-09-14T15:56:16.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145704

The Senate voted 12/10 to approve on a 91-2 vote [S. 2740](https://www.isakson.senate.gov/public/%5Fcache/files/30339af5-2973-46a1-842b-68a5b4dcaf87/10-30-19%20OTC%20116th%20as%20introduced.pdf?ref=fdaweb.com), the Over-the-Counter Drug Safety, Innovation, and Reform Act, which its sponsors say will streamline and modernize FDA’s regulatory system. A [statement](https://www.isakson.senate.gov/public/index.cfm/news-releases?ID=6EADF9EC-2159-4EE9-A80B-E68815F971C1&ref=fdaweb.com) from Sens. **Johnny Isakson** (R-GA) and **Bob Casey** (D-PA) says the bill would: 

- change the “cumbersome” monograph rulemaking process to an administrative order process such as used for other medical product approvals;
- allow the HHS secretary to take rapid action to protect public health in the event of safety issues;
- establish processes for manufacturers to request administrative orders, or for the HHS secretary to initiate administrative orders at the recommendation of FDA or in response to citizens’ petitions;
- establish a process by which drug developers can request meetings with FDA similar to existing processes for prescription drug development;
- create a new incentive to bring innovative over-the-counter products to consumers by providing an 18-month period of product exclusivity to reward innovation;
- require an annual update to Congress on FDA evaluation of the cold and cough monograph with respect to children under age six; and
- authorize FDA to collect user fees to provide the necessary resources to evaluate and monitor the over-the-counter market.