Congresswoman Diana DeGette

Representing the First District of Colorado
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House approves bill aimed at making over-the-counter drugs safer, more available for consumers

Jan 8, 2019
Press Release

Washington, DC – The U.S. House of Representatives today approved legislation aimed at improving and speeding up the federal Food and Drug Administration’s process for evaluating new over-the-counter (OTC) medications to determine whether they are safe enough to be sold to consumers without a prescription.

The legislation, sponsored by U.S. Rep. Diana DeGette (D-CO), would streamline the process that’s currently used by the FDA to evaluate OTC drugs, reducing the time it takes for new, safe OTC drugs to be made available to consumers – while at the same giving the agency the tools it needs to more quickly address any safety concerns.

“The current process that the FDA uses to evaluate new over-the-counter medications hasn’t been updated since the 1970s,” DeGette said. “This legislation will modernize the agency’s approach to help make more safe over-the-counter drugs available to consumers sooner, while at the same time giving the agency additional tools to more quickly address any drug safety issues that may arise in the future.”

The FDA’s current drug-approval process was developed in the 1970s. Proponents of the bill approved today claim the FDA’s outdated approval and oversight process has failed to keep pace with the nation’s growing over-the-counter drug market, which now boasts more than 300,000 products; and it’s been blamed for hampering innovation, as well as the agency’s ability to respond to any drug safety concerns in a timely manner.

In 2007, for example, the Centers for Disease Control reported that 1,500 babies and toddlers were taken to emergency rooms over a two year period from 2005 to 2006 after having bad reactions to over-the-counter cold medicines. The report emphasized the need for Congress to act – as the House did today – to modernize the agency’s approach to approving such drugs.

The bill, H.R. 269, now heads to the Senate for consideration.

A copy of the bill is available here.