Federal court overturns FDA pediatric drug testing rule
Bills before the House and Senate would require drug testing in
children, but passage is uncertain.
By
Tanya Albert, AMNews staff. Nov. 18, 2002.
Additional information
In light of an October court decision, pediatricians are renewing their
push for legislation requiring drug companies to test products in children
to ensure that medications are safe and effective for them.
The U.S. District Court for the District of Columbia ruled that the
Food and Drug Administration had exceeded its authority when it created
the 1998 Pediatric Rule, which allows the agency to require companies to
conduct clinical trials in children.
The opinion agreed with the arguments made by the Arizona-based Assn.
of American Physicians and Surgeons and two conservative public interest
groups -- Consumer Alert and the Competitive Enterprise Institute. The
organizations sued the FDA in December 2000.
The court said that only Congress could grant the FDA the authority
over pharmaceutical firms that is found in the Pediatric Rule.
"This court does not pass judgment on the merits of the FDA's
regulatory scheme," U.S. District Court Judge Henry H. Kennedy Jr. wrote
for the court. "The Pediatric Rule may well be a better policy tool than
the one enacted by Congress; it might reflect the most thoughtful,
reasoned, balanced solution to a vexing public health problem. ... The
issue is the rule's statutory authority, and it is this that the court
finds lacking."
The 57,000-member American Academy of Pediatrics and other groups this
spring already had started to lobby Congress to codify the Pediatric Rule.
Efforts began when the FDA in March announced that it would suspend the
rule. Government officials quickly changed their minds, and in April the
Dept. of Health and Human Services announced that it would continue to
enforce the rule.
But the October court decision has recharged the AAP's and lawmakers'
efforts for Congress to pass Pediatric Rule legislation.
"It's very clear now what Congress has to do," said pediatrician Philip
D. Walson, MD, who serves on the AAP's Committee on Drugs and Clinical
Pharmacology and is director of clinical pharmacology at Children's
Hospital Medical Center in Cincinnati. "They have to make it clear that
the FDA has to protect children."
Lawmakers in both chambers already have introduced legislation, but it
is unclear if anything will pass before the end of the year.
A bipartisan group of lawmakers, including Sens. Hillary Rodham Clinton
(D, N.Y.) and Mike DeWine (R, Ohio), offered a measure in the Senate in
late April. In August, the Health, Education, Labor and Pensions Committee
unanimously passed it.
"The protections that we have relied on since 1998 to assure the safety
and efficacy of your children's medicine have been taken away," Clinton
said about the October decision. "This court ruling underscores the need
for immediate congressional action."
In the House, Reps. Deborah Pryce (R, Ohio) and Connie Morella (R, Md.)
introduced legislation in October, just before the court ruled. The bill
was referred to the Energy and Commerce Committee, and at press time the
panel had not taken up the issue.
Championing their causes
The physicians and surgeons association opposes the legislation. In
addition to arguing that the FDA overstepped its bounds, the AAPS and
others who filed the lawsuit against the Pediatric Rule said they did so
because they thought it delayed approval of medications for adults and
exposed children in clinical trials to unnecessary danger.
"We have a major ethical problem with testing in children," said Jane
M. Orient, MD, AAPS executive director. "It is senseless for the FDA to
require pediatric testing for drugs that expressly disclaim any use on
children. Would you volunteer your child for experimental trials?"
Dr. Orient said doctors for all age groups have to decide what
medications at what dosages they will use to treat patients; they have
guidelines to help them make those judgments. She noted that testing isn't
done on pregnant women or elderly people, either.
Instead of clinical trials that test medications on a small percentage
of people, closely monitoring patients' reactions to drugs is a better way
to gather information, she said.
"Children who receive a drug tested on adults, as an off-label
prescription, arguably are at greater risk than children taking a drug
that has already been extensively tested in a pediatric population," Dr.
Orient wrote in a letter to Sen. Judd Gregg (R, N.H.), the ranking member
of the Health, Education, Labor and Pensions Committee. "However, they are
at no greater risk than an experimental subject would be, and they also
reap the potential benefit of a more effective treatment.
"There is no reason to think that the supervision of a physician who is
dedicated solely to patient welfare is less protective than that of a
physician who is in the dual role of physician-researcher," she added.
But the AAP disagrees. Failure to test medications on children, whose
bodies react to medications differently from adults' bodies, puts them at
great risk, the AAP said.
Dr. Walson said there had been cases in which drugs that work in adults
had no results in children or in which doses adjusted for children still
had been harmful.
"Even those of us in pediatrics who thought we were making good,
educated decisions have found out what we thought was rational wasn't," he
said. "There were some major surprises for things we didn't predict."
That's why testing is important, Dr. Walson said. "We are learning over
and over again that there are a lot of differences in children. It's
amazing to say that it's not a good thing to test in children. Let's turn
it around and imagine drugs were tested only in children, and doctors say
to an adult, 'We have a good idea how to use it.' How long would adults
stand for that?"
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ADDITIONAL INFORMATION:
Case at a glance
Assn. of American Physicians and Surgeons et al. v. U.S. Food and
Drug Administration et al.
Venue: U.S. District Court for the District of Columbia
At issue: Whether the FDA had the authority to create a rule that
requires drugmakers to test their products in children. The court said no.
Potential impact: Those who filed the lawsuit say it is a great win
because children shouldn't be used as guineas pigs. Others, including the
American Academy of Pediatrics, say the ruling is a terrible blow to
guaranteeing that medications prescribed to children are safe for them.
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Weblink
Memorandum opinion
of the U.S. District Court for the District of Columbia in Assn. of
American Physicians and Surgeons v. U.S. Food and Drug Administration,
in pdf (http://www.dcd.uscourts.gov/00-02898.pdf)
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Copyright 2002 American Medical Association. All
rights reserved.
