The NHF has
been closely following a federal court case that could
fundamentally change the longstanding FDA abuse of
power that has restricted individuals' rights to
choose to consume healthy food, take supplements, and
use alternative drugs and therapies without government
restrictions.
On March 1, 2007, the U.S. Court of Appeals for the
District of Columbia heard arguments in a landmark
case to decide if terminally ill patients have a
constitutional right to have access to
"unapproved/experimental drugs" that have not been
fully approved for medical use by the FDA.
In 2003, the Washington Legal Foundation (WLF) sued
the FDA to overturn its policies denying these
patients access to "unapproved/experimental drugs",
when they are the only treatments available to them
and their physicians. In 2003, a three-judge panel
ruled against the FDA when deciding that terminal
patients do have a constitutional right to such drugs.
These are drugs approved for clinical testing but not
fully approved by the FDA. The court also decided to
rehear the case in front of all of its 10 judges. A
final court decision is not expected until September
or October of this year.
As previously reported by the NHF, the FDA has a
proposed regulation that would grant people and their
physician the ability to access drugs and therapies
undergoing FDA approval, but not yet approved. The
proposed regulation is very narrowly written. The
“experimental/investigational" new drug/treatment
change would only apply when a serious disease or
condition has been diagnosed, when no approved drug
has worked, and when no other treatment options exist.
It has other FDA restrictions on what physicians must
do, and gives the FDA the final authority on who and
how this would be done.
If decided against the FDA, the WLF case would
establish case law recognizing an individual's
constitutional right to exercise health freedom of
choice and access for a class of American patients,
and physicians, without overbearing FDA interference.
It would protect against a future change in FDA policy
that could reverse the newly proposed regulation.
More information, from the WLF, ( www.wlf.org/ ) on
this case is included in the attached PDF:
