> ## 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.

# Pew Trusts Sees Need for OTC Monograph Reform
- URL: https://www.fdaweb.com/pew-trusts-sees-need-for-otc-monograph-reform/
- Published: 2019-05-15T12:00:00.000Z
- Updated: 2026-09-15T01:26:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144112

The Pew Charitable Trusts says it supports the bipartisan Over-the-Counter Monograph Safety, Innovation, and Reform Act to modernize the monograph system by eliminating what it says is the “burdensome” rule-making process for changing monographs and expand FDA funding through user fees paid by manufacturers of over-the-counter products. In a [statement](https://www.pewtrusts.org/en/research-and-analysis/articles/2019/05/14/pew-funded-scientists-shape-the-future-of-biomedical-research?ref=fdaweb.com), the group says the fact that it took FDA 45 years to update the monograph for over-the-counter hand sanitizers illustrates why the agency and many stakeholders are calling for legislative reform of the monograph system.

The process for updating monographs is cumbersome, Pew says, with FDA and HHS reviewing proposed changes while the Office of Management and Budget often estimates the cost and benefit of any changes to the economy and consumers. Further, FDA must solicit and respond to public comment throughout the revision process. “Altogether, these efforts can, and often do, take decades to complete,” the statement says. “By contrast new drug applications are reviewed solely by FDA to determine whether the product is safe and effective. Approvals can be completed in as little as six months.”

The Trusts statement quotes CDER director **Janet Woodcock** saying last year that “without the passage of monograph reform legislation, the shortcomings of the existing, out-of-date monograph system will continue and worsen. Challenges in accommodating innovation and keeping pace with evolving science will remain.”