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Possible Changes to How the FDA Regulates Over-the-Counter Drugs

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Kayla Rouser4 years ago

The U.S. Food and Drug Adminstration (FDA) has proposed a new set of standards to regulate over-the-counter drugs as numerous studies suggest that different drugs can have varying effects on the human body even if they share the same active indredients.

About the FDA’s changes

“It’s a good sign that the FDA has recognized its oversight of OTC medications is outdated, and the danger that can pose to patients.” Most people take OTC drugs without first consulting a doctor.” – Carmen Balber, executive director of Consumer Watchdog as published by Reuters

According to Reuters, in an effort to make it easier for consumers to react to new information on a products safety or recommended use, the U.S Food and Drug Administration is proposing changes to how it regulates over-the-counter drugs. 

The current rules for nonprescription medicines like asprin and allergy medicines are over 40 years old, and do not require manufacturers to get an approval as long as the main ingredient has previously been deemed safe and effective for that entire category of medications.

However, recent activity by federal regulators has suggested that such procedures are no longer effective. For example, the FDA has recently sought to lower the dosage of painkiller acetaminophen from 500 milligrams, due to its current risk of liver damage.

New Information on Dosing

The FDA originally believed that safety and effectiveness evaluations for the various active ingredients would be straightforward, requiring little review after initial approval – that, however, is no longer the case given the ever evolving knowledge of how drugs work in and affect the body.  

In the 1970’s, the approach was to typically reduce adult doses by a percentage to treat children. That was another example of the outdated science cited by the health regulator for children.

Over the counter drugs can be marketed under the FDA’s monograph process which describes the standard and conditions for marketing entire classes of OTC drugs that are generally recognized as safe and effective. If an OTC drug meets the conditions contained in any given monograph, companies do not have to file a new drug application and have the product individually reviewed by the FDA.

The FDA has stated that a large number of products are on the market pending finalization of monographs, which means that there may not be enough data for the FDA to determine whether they are safe or effective. The Consumer Healthcare Products Association (CHPA), an industry trade groups strongly supports the OTC monograph system.


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