Court sees no right to unapproved medicines

Please note that some patients are excluded from clinical trials because
they don't fit the trial criteria of the trial, or don't live close enough
to the closest trial location and other.

http://www.clinicaltrials.gov/
This is part of Understanding Clinical Trials - information explaining and
describing clinical trials
In Phase I trials, researchers test an experimental drug or treatment in a
small group of people (20-80) for the first time to evaluate its safety,
determine a safe dosage range, and identify side effects.

In Phase II trials, the experimental study drug or treatment is given to a
larger group of people (100-300) to see if it is effective and to further
evaluate its safety.

In Phase III trials, the experimental study drug or treatment is given to
large groups of people (1,000-3,000) to confirm its effectiveness, monitor
side effects, compare it to commonly used treatments, and collect
information that will allow the experimental drug or treatment to be used
safely.

In Phase IV trials, post marketing studies delineate additional
information including the drug's risks, benefits, and optimal use.
J

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http://www.reuters.com/article/domesticNews/idUSN0723277720070807?pageNumber=1

Court sees no right to unapproved medicines
Tue Aug 7, 2007 4:11PM EDT
By Lisa Richwine

WASHINGTON (Reuters) - Terminally ill patients do not have a
constitutional right to experimental drugs not approved by regulators, a
U.S. appeals court ruled on Tuesday.

The U.S. Food and Drug Administration requires a wide battery of research,
ranging from animal and laboratory tests to advanced trials with people,
before it will consider approving a new drug. Manufacturers say the
process can take up to 10 years.

Two advocacy groups have sued the FDA seeking greater access for dying
patients to unapproved medicines that have cleared early safety tests,
which usually include 20 to 80 people.

The Abigail Alliance for Better Access to Developmental Drugs and the
Washington Legal Foundation argued that patients have a constitutional
right to try experimental drugs that have passed that hurdle, if they
choose.

The 8-2 ruling by the full U.S. Court of Appeals for the District of
Columbia reversed a May 2006 ruling by a divided three-judge appeals
panel, which overturned a 2004 district court decision to throw out the
case.

"The FDA's policy of limiting access to investigational drugs is
rationally related to the legitimate state interest of protecting
patients, including the terminally ill, from potentially unsafe drugs with
unknown therapeutic effects," Judge Thomas Griffith wrote in Tuesday's
majority opinion.

The Abigail Alliance and the Washington Legal Foundation said they planned
to appeal the latest ruling to the Supreme Court.

"We are saddened by the decision and so are the patients we represent,"
said Frank Burroughs, the group's president.

Every drug the group has sought early access to over the past six years
was eventually approved by the FDA, Burroughs said.

While some patients can take experimental drugs as part of a clinical
trial or other programs, many patients are excluded. The FDA proposed new
rules in December 2006 that officials said would help more seriously ill
patients gain access.

FDA spokeswoman Julie Zawisza said the agency was pleased with the appeals
court ruling.

The decision "upholds the constitutionality of FDA's role in facilitating
appropriate treatment access to investigational therapies," Zawisza said.
It also protects the public by requiring that drugs be proven safe and
effective before they are sold, she added.

In a dissenting opinion, Judge Judith Rogers wrote: "There is no logic to
be found ... in the conclusion that the right to save one's life is
unprotected" by the Constitution.


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