US scrutinises OTC monograph process

US scrutinises OTC monograph process

9 April 2014 - Deborah Wilkes

A wide range of suggestions for changing the US OTC drug review were put forward by speakers at a recent public hearing on the regulatory system that was organised by the US Food and Drug Administration (FDA).

This NEWS EXTRA publication from OTCToolbox reports the comments made by FDA officials, including Dr Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research (CDER). It also covers the suggestions made by representatives from McNeil Consumer Healthcare, Procter & Gamble and the US Consumer Healthcare Products Association (CHPA), including a proposal to introduce public-private partnerships into the regulation of OTC products in the US.

The FDA held the public hearing on the US OTC drug review, also known as the OTC monograph process, to help decide "whether and how to modernise" the regulatory system, which was introduced 40 years ago. The regulatory agency said it was interested in hearing ideas for changes to the existing OTC monograph process or ideas for its replacement with an entirely new regulatory or statutory framework.

Around 4,000 words long, this NEWS EXTRA publication from OTCToolbox is designed to provide an overview of the views expressed at the public hearing on 25 and 26 March 2014. Many speakers at the public hearing urged the FDA to stick with the current system, but they also had plenty of suggestions for making the OTC monograph process more efficient.


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