FDA Weighs New Over-the-Counter Drug Approval Process

The FDA is looking to update its approval process for over-the-counter (OTC) drugs, seeking to be able to more rapidly respond to the discovery of new side effects, the development of new active ingredients, and to be able to get drugs approved for the market faster.  

Earlier this month, Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research (CDER) published a blog post calling for public comment on how the agency can improve the OTC drug approval process. Woodcock said that the current system is outdated, inflexible, and takes too long to get things done.

“When it comes to drug approval in the United States, the focus of discussion often revolves around FDA’s efforts to approve new prescription drugs. But it’s important to remember that we also regulate over-the-counter (OTC) products, including many different drugs such as pain relievers, antacids, and cough and cold medicines,” Woodcock said in the blog. “Frankly, that process is outdated and does not work as quickly as FDA would like.”

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The current process, known as the OTC monograph approval process, is responsible for the regulation of more than 300,000 OTC drugs currently on the market. Each drug is required to have a monograph that details the amount and types of active ingredients, permitted uses, and drug facts. However, the agency does not require that the drugs meet the monograph requirements before being marketed to consumers, Woodcock notes.

In late March, the FDA held a two-day public meeting to get input on ideas for overhauling OTC regulations. The agency will continue to take public comment on the issue until May 12. In her blog post, Woodcock urged the public to submit their ideas on what the FDA should do to make the OTC approval process safer, faster and more efficient.

“The current process involves rulemaking, and it is slow and cumbersome,” Woodcock said. “For example, the rulemaking process doesn’t allow FDA to quickly require changes to OTC drugs, or to require new warnings or other label changes to products when safety concerns arise. In addition, science is advancing quickly, and new ingredients have been developed that aren’t included in the monographs.”

Over-the-Counter Tylenol Concerns

One example of where the FDA has struggled with OTC drug concerns is Johnson & Johnson’s popular pain reliever Tylenol and its active ingredient, acetaminophen.

The FDA has previously identified acetaminophen as the leading cause of liver injury in the United States. It has been suggested that more than 50,000 emergency room visits each year are caused by acetaminophen, including 25,000 hospitalizations and 450 deaths.

While the agency has taken action against prescription drugs, including warning doctors about high-acetaminophen drugs and pushing manufacturers to remove combination pain killers containing more than 325 mg of acetaminophen off the market, it has taken little action at the OTC level and Extra Strength Tylenol is still sold containing 500 mg of acetaminophen in each tablet.

In 2011, Johnson & Johnson agreed to lower the maximum recommended dosage for Tylenol from 4,000 mg per day to 3,000 mg per day, after the FDA announced the new limits on acetaminophen levels in prescription painkillers like Vicodin and Percocet. However, concerns have been raised about the narrow margin between the recommended dose and the risk of liver failure from Extra Strength Tylenol if users take more than six Extra Strength tablets every 25 hours.

A growing number of Tylenol lawsuits are being pursued against Johnson & Johnson in state and federal courts throughout the country on behalf of former users who suffered liver damage, liver failure or death. The complaints allege that Johnson & Johnson has built the global impression that Tylenol is safe by withholding information about the potential risks associated with acetaminophen for decades. Many of the complaints suggest that the FDA would never approve Tylenol as an over-the-counter medication if it were first introduced today.


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