By Toni Clarke and Bill Berkrot
WASHINGTON/NEW YORK Feb 21 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
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of OTC medications is outdated, and the danger that can pose to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Another example of outdated science cited by the health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
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