The U.S. Food and Drug Administration has launched a review of
the way it ensures the safety and use of over-the-counter drugs taken by hundreds
of millions of Americans, opening the door to the most significant reform in
four decades.
The agency’s announcement
follows a ProPublica investigation
last fall focusing on acetaminophen, the active ingredient in Tylenol, which is
among the drugs that would fall within the review.
As we reported, despite more than 40 years of work, the FDA
has yet to finalize rules governing the safe use of acetaminophen, hobbled, in
part, by the cumbersome and bureaucratic system for regulating non-prescription
drugs.
Acetaminophen can cause liver damage and death in amounts
close to the current recommended daily limit. Our investigation found that
about 150 people die each year from accidentally taking too much of the drug. Tens
of thousands of others are rushed to the emergency room or hospitalized.
FDA officials have complained that the system in place since
the early 1970s, known as the monograph process, is too slow to adjust to
emerging safety issues.
“When we look at how rapidly science now evolves and the
impact this has had on the emergence of drug safety issues and on drug
development, it is clear to that a
more agile and responsive process” is needed for over-the –counter drugs,
the agency said in a response to questions.
Our investigation showed that such delays have sometimes
carried a high cost. The agency spent
at least 15 years arguing with Tylenol’s manufacturer, Johnson and Johnson unit
McNeil Consumer Healthcare, on how to improve the safety of pediatric
acetaminophen. During that time, some 20 children died after their parents
accidentally gave them overdoses of the medicine.
In contrast, the prescription drug system allows the agency
to make relatively quick changes to warning labels or dosage instructions. For
instance, the FDA recently announced
that prescription medications containing acetaminophen could contain no more
than 325 milligrams of the drug, citing the potential health risk.
But consumers can still buy pills with twice that amount of
acetaminophen over the counter at drug stores and supermarkets because the
monograph system requires lengthy periods of debate and public comment.
The FDA announcement reaches far beyond acetaminophen.
Developed in the 1970s, the monograph process was intended
to hasten the evaluation of thousands of drugs historically sold
over-the-counter.
Instead, the process got bogged down as consumers, drug
makers and the FDA debated safety issues. Only about 60% of more than 1,700
active ingredients have received final approval, according to an agency database.
The remaining 40% of ingredients — including acetaminophen — are in different
stages, though they can be legally sold.
The monograph system “presents challenges to FDA’s ability
to respond to emerging safety issues, keep pace with evolving science, and
ensure the consistent safety and effectiveness of varying formulations,” the
agency said.
The agency’s review could affect the regulation of tens of
thousands of products sold without a prescription, from acne cream to weight
control drugs.
Agency officials said they are considering whether to
streamline the process to quickly wrap up currently open safety reviews, to
allow for new rules issued by administrative order and to expand the use of
regulatory guidelines. Some of the agency’s ideas would require Congressional
action.
In a statement,
the Consumer Healthcare Products Association, the industry’s trade group, welcomed
the beginning of discussions over a new regulatory system. However, officials
noted that the current system has worked well for thousands of products now on
the market.
“The system 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 group said.
The FDA’s announcement also comes as new concerns have
emerged over the safety of acetaminophen, also known as paracetamol.
An investigation
by the Toronto Star, which was aided by ProPublica, found that Canadian
coroners and medical examiners had investigated at least 156 deaths since 2006
where acetaminophen was “deemed to be the sole or contributing cause —
and the manner of death was either accidental or “unclassified,” meaning
suicide and homicide had been ruled out.”
A recent study
in the Journal of the American Medical Association, Pediatrics found that
mothers in Denmark who used acetaminophen during pregnancy had a heightened
risk of having children who developed attention-deficit/hyperactivity disorder,
or ADHD.
