USA – OTC Monograph Reform is Now Law: What’s Next?

This article discusses the impact of over-the-counter (OTC) monograph reform, part of the recently passed Coronavirus Aid, Relief and Economic Security (CARES) Act.

Regulators and public health stakeholders have been championing OTC monograph reform for more than five years. Then, in what seems like a blink of any eye, it is now law, passed by Congress and signed by the President on 27 March 2020 as part of the CARES Act for pandemic relief. The new law reflects the major reforms sought by the US Food and Drug Administration (FDA) and industry and, once implemented, will deliver a modernized regulatory system covering about 60% of OTC medicines that is more responsive and more transparent than the prior system while continuing to ensure these medicines are safe for consumers.

The reform law provides more than $110 million over five years of OTC monograph user fee authorization for FDA to significantly increase capacity and expertise in the Office of Nonprescription Drug Products. With this increased funding, FDA’s capacity to work on OTC monograph ingredients will more than triple over the next five years…