FDA Overhauls Drug Approval Path for OTC Drugs

FDA Overhauls Drug Approval Path for OTC Drugs

February 26th, 2014 // 4:29 pm @

FDA announced last week that it is going to overhaul how it approves OTC medical products. There is no doubt that this is going to make big changes to how thousands of drugs and personal care items are going to get to stores in the US.

The products that will have the approval process changed will include pain relievers, sunscreens, antifungal drugs and some medical devices. These items were for many years approved through a laborious process that usually reduces the ability of the manufacturers to change the products later.

A revamping of the approval process would have serious implications for the OTC drug and medical product industry. The industry will in theory be able to come up with new products faster for the market, as researchers learn of better ingredients.

The current FDA approval process for OTC drugs was created over 40 years ago. FDA says that it needs a total overhaul so that it is more responsive and agile to change. FDA is holding a public hearing in late March to consider ideas on this process.

At the heart of the matter are more than 20,000 drugs and products that are created through the monograph process, which is very distinct from the one where most of our prescription drugs go through FDA testing and approval.

Janet Woodcock, CDER’s director, said that the current system for OTC drug approval is not working. She said that FDA wants monograph drugs to have the same framework of safety as prescription products.

FDA noted last week that it is mulling some changes that will include improving the agency’s ability to require new warnings fast, or label changes, as new safety problems come to light as new science develops. It also wants to have better dosing limits for children that is based upon recent research.

A good example of the problems with the current OTC system is the 500 mg Tylenol pill. It is still being sold even though it is well known that that dose of acetaminophen can cause liver problems.

FDA stated that the highest dosage of the Tylenol pill should be only 325 mg, but the current regulatory environment does not allow quick changes.

The Consumer Healthcare Products Association states that the group generally is supportive of making the FDA approval process for OTC drugs more efficient.


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