Press
Release:
Saturday, August 21, 2004
Contact information:
President: Patricia Weathers, (845) 677-8115
National Vice President: Sheila Matthews, (203) 966-8419
FDA
Update on Review of Antidepressants
Used
as Tool for Drug Companies to
Seek
Pediatric Approval for Antidepressant
Use
in Children
Ablechild.org
Requests that the FDA Withdraw Antidepressant Drug Applications that Seek Drug
Approval at Upcoming Advisory Review Committee Meeting on September 13th and
14th, 2004 in Bethesda, Maryland.
According
to the FDA’s Talk Paper on the safety review of antidepressants dated August
20th, there are findings among drug trials that suggest an increase risk of
suicide in children, but interpretation of these findings represents a “substantial
challenge”. Despite
these findings, and the fact that the UK last year banned the use of 8 of these
antidepressants for use in children, the FDA has attached to their Talk Paper,
applications from drug companies, which seek to approve these same drugs for
children. (See link attachment on FDA Talk Paper http://www.fda.gov/cder/pediatric/Summaryreview.htm).
The
fact is that these drugs have
never been approved for use in children.
These drugs were being prescribed in what is termed an “off-label
loophole”, whereby a doctor could prescribe any of these drugs for a child at
his own discretion.
With
these facts, and the link to suicide in children, the America public should be
alarmed that the FDA is allowing these drug applications to be considered during
this safety review process.
“As
part of its commitment to keep the American public fully informed about the
status of its review of data concerning the use of antidepressants in pediatric
patients, the FDA is issuing this update to provide healthcare providers and
patients with the most current information on this topic.”
How
is this statement fulfilling the FDA’s commitment to fully inform the public,
when in fact, they are simultaneously submitting new applications from various
drugs companies that would approve the use of these same drugs for children?
There was a total of 203 press alerts across the wires yesterday on the
FDA’s Safety Update on Antidepressants, all of which excluded the “fine
print” located at the bottom of the FDA’s Talk Paper that links new
applications to the safety review process.
Is this the FDA’s commitment to fully inform the American public?
“The
FDA will assure that the labels of the antidepressants used in pediatric
patients reflect the most recent information obtained from these same studies
and analyses”.
Let’s
get to the plan at hand. Is it the
intent of the FDA to approve these suicide-linked drugs for use in children, and
then slap warning labels on the package after approval?
The
September FDA Advisory Committee Meeting that is conducting this review should
be acting in accordance with U.S. Code Title 42: Section 289a-1: Part H –
General Provisions regarding review and approval of proposal for research under
Section (b) Ethical
Review of Research. This
Advisory Committee has an obligation to the protection of human research and
under section (2) the
peer review and in the case of any proposal for the National
Institutes of Health to conduct or support research; the Secretary may not
approve or fund any proposal that is subject to technical
and scientific peer review.
Based
on these procedural safeguards and guidelines, these antidepressant drug
applications that seek drug approval for use in children should be withdrawn
immediately from the September FDA Advisory Committee Meeting Agenda.
As
a public health agency, the FDA must protect public health, not manage risks
associated with depression that goes untreated, especially when that
“treatment” itself is inducing suicide ideation that results in death.
It appears the pending strategy seems to be, approve the drugs for use in children, and then warn of risks. This is unacceptable.