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More FDA Oversight for Over the Counter Drugs?

by Elizabeth Davis on February 26, 2014 at 2:23 pm

The FDA has announced a public hearing in March 2014 to discuss updating the review and approval process of over the counter (OTC) drugs.

The hearing itself doesn’t mean there will be any changes to the process, but the FDA hopes to address issues like misbranding, the large number of non-prescription drugs on the market that haven’t been evaluated at all, and the current limitation on the FDA’s ability to require changes to products or labeling.

They also hope to streamline and modernize the review process, allowing for quicker approvals and changes to existing products.

One reason why the process needs to be fixed? The FDA recently asked that prescription manufacturers remove all products containing more than 325 mg of acetaminophen (Tylenol) from the market, due to concerns about accidental overdoses and liver damage. However, OTC Tylenol and acetaminophen are still available in 500 mg extra strength formulas. (See our previous post for more information.)

Better (not just more) oversight from the FDA on OTC products could help ensure that you stay safe, and that you’re getting what you expect from your medications, whether you need a prescription or not.

For more information on the FDA hearing, see the announcement here—and watch for more developments after the meeting in March.


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