FDA to Hold Workshop on Risks and Benefits of “Candy-Like” Nonprescription Drugs

Stakeholders are being asked to consider the risks of candy-like medications, such as child poisoning, as well as benefits that may include better patient adherence to prescribed dosing.

Federal drug regulators are raising concerns over the candy-like appearance of more and more over-the-counter medications, as drug companies try to make them more attractive to consumers.

Late last month, the U.S. Food and Drug Administration (FDA) announced it plans to hold a public workshop on “candy-like” drugs on October 30, which will be hosted by the Office of Nonprescription Drugs (ONPD) and the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI).

The workshop is intended to bring together FDA officials, representatives from academia, and representatives from the drug industry to discuss the risks and benefits of marketing drugs to look and taste like candy.

In calling for the hearing, the FDA indicates alternatives to solid oral tablet medications are becoming more common. Manufacturers want to make drugs better tasting and more appealing for consumers, so many have turned to candy-like flavored features. This can range from bubble gum-flavored antibiotics to cherry-flavored cold medicine.

However, there are growing concerns that many products are being confused with candy and non-drug products, which can lead to an increased risk of child drug poisonings.

Defining “Candy-like” Drugs and Poisoning Risks

The FDA indicates it currently does not have a clear definition of what constitutes a “candy-like” drug product. Agency officials say they hope participants in the upcoming public workshop will help to address that problem.

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In addition to defining what “candy-like” means, the workshop will also include discussions on how drugs that look and taste like candy are viewed by consumers, and discussions on how appropriate doses should be determined with these new formulations.

The public workshop will also include presentations and panel discussions on formulation of candy-like drugs, how they affect patient willingness to adhere to prescribing and dosing, and discussions on accidental child exposure and overdoses.

The workshop will be held on October 30 from 8:30 a.m. to 4 p.m. at the FDA White Oak Campus in Silver Spring, Maryland. Attendees must register at eventbrite.com.


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