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FDA OTC Drug Reform

Modernizing the OTC Development/Review Process

A statement from the FDA:

 

On Friday, the President signed into law a $2 trillion emergency relief bill that will continue to aid the response efforts and ease the economic impact of COVID-19. The legislation will help all of us at the FDA deliver support and guidance to protect and promote public health during this unprecedented pandemic.

Specifically, the legislation provided an additional $80 million in funding to continue the Agency’s COVID-19 response efforts, including the development of medical countermeasures and vaccines, promoting the advanced manufacturing of medical products and monitoring of the medical product supply chain. The FDA thanks Congress for its continued support of these crucial efforts and looks forward to continuing to work with members of Congress on all legislative efforts to mitigate the impact of COVID-19 on public health.

Additionally, we want to specifically highlight the portion of the bill that reforms and modernizes the way certain over-the-counter (OTC) drugs are regulated in the United States – a landmark step that will have an impact lasting long after the current public health emergency. The law grants the FDA transformative, new authorities that will meaningfully advance our efforts to modernize the OTC drug development and review process to help advance innovative, safe and effective options for consumers and secure a robust OTC marketplace. The FDA is committed to using these new tools to promote innovation and improve the safety and effectiveness of OTC monograph drugs – including products like hand sanitizers and acetaminophen, which are so critical to the public health emergency we face right now. We look forward to providing updates as we implement this important new law.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

 

Read on the FDA site.

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