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FDA seeks to modernize over-the counter drug reviews

By Toni Clarke and Bill Berkrot

WASHINGTON/NEW YORK (Reuters) - The U.S. Food and Drug Administration is proposing sweeping changes to how it regulates over-the-counter drugs from aspirin to allergy medications to make it easier to react to new information on a product's safety or recommended use.

The agency's current rules for nonprescription medicines are more than 40 years old, and do not require manufacturers to get approval as long as the main ingredient had previously been deemed safe and effective for that entire category of medications. They do not allow the agency to respond quickly when new data emerges about a drug's potential side effects, the agency said in documents filed on Friday .

As one example, the FDA has sought to lower the dosage of painkiller acetaminophen from 500 milligrams in widely used products such as "extra strength" Tylenol to 325 mg, based on current knowledge of the liver damage the drug can cause.

"We believe the OTC dose should be changed, but it will take a long, long process because it can only change through rulemaking," FDA spokeswoman Andrea Fischer said in an emailed statement. In contrast, the FDA was able to act swiftly to require such a change for prescription pain treatments that contain acetaminophen.

The FDA is looking for suggested changes to the existing process, as well as ideas to replace it "with an entirely new regulatory or statutory framework." It has scheduled a hearing for public comments on March 25 and March 26.

"It's a good sign that the FDA has recognized its oversight of OTC medications is outdated, and the danger that can pose to patients," said Carmen Balber, executive director of Consumer Watchdog, a consumer advocacy group.

She noted that most people take over-the-counter drugs without first consulting a doctor.

"Patients need to know right away when new information is discovered about drugs that are a risk to patient safety, and the FDA needs the ability to act quickly to require new labeling from drug companies," Balber said.

NEW DATA ON DOSING

When the review process was established for nonprescription drugs, the FDA said, "it was generally thought that safety and effectiveness evaluations for the various active ingredients would be fairly straightforward and would not necessarily need continuous reexamination over time."

That is no longer the case, the agency said, given ever evolving knowledge of how drugs work in and affect the body.

Another example of outdated science cited by the health regulator is the dosing instructions for using some over-the-counter medicines in children. In the 1970s, the approach was typically to reduce adult doses by a percentage, the FDA said.

"The preferred approach to pediatric dosing has changed. Ideally, data from actual use in the pediatric population would be needed for an indication for use in children," the document said.

Over-the-counter drugs can be marketed under the FDA's monograph process. A monograph describes the standards 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 Consumer Healthcare Products Association (CHPA), an industry trade group, said in a statement that its members "strongly support" the OTC Monograph system.

It said the current system "effectively and efficiently regulates the majority of OTC medicines on the U.S. market" and "ensures consumers have access to a wide variety of safe and effective medicines, while at the same time providing FDA with access to important information on safety and quality."

The FDA said a large number of products are on the market pending finalization of monographs, meaning there may not be enough data for the FDA to determine whether they are safe or effective.

(Editing by Michele Gershberg, Grant McCool and Marguerita Choy)

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