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 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medications is outdated, and the danger that can pose to patients,"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.
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Another example of outdated science cited by the health regulator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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