Medical Foods Under the Orphan Drug Act
Tuesday, May 14, 2013 19:57
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MEDICAL FOODS UNDER THE ORPHAN DRUG ACT
Physicians’ Use of Dietary Supplements and Nutrients as Therapy that May
Benefit
Physicians’ Use of Dietary Supplements and Nutrients as Therapy that May
Benefit
Medical Foods do not treat
disease; rather, they support optimal clinical outcomes by nourishing normal
structure and function. A “Medical Food” under the 2005 Orphan Drug Act is an
food or dietary supplement that is recommended by a physician for the dietary
management of a medical condition. When recommended by a physician, the nutrient
can be considered as Medical Food protected under the Act.
disease; rather, they support optimal clinical outcomes by nourishing normal
structure and function. A “Medical Food” under the 2005 Orphan Drug Act is an
food or dietary supplement that is recommended by a physician for the dietary
management of a medical condition. When recommended by a physician, the nutrient
can be considered as Medical Food protected under the Act.
Here is how the Orphan Drug
Act defines a Medical Food:
Act defines a Medical Food:
“…a food which is formulated to be consumed or
administered enterally under the supervision of a physician and which is
intended for the specific dietary management of a disease or condition for
which distinctive nutritional requirements, based on recognized scientific
principles, are established by medical evaluation….” Section 5(b) of the Orphan Drug Act
(21 U.S.C. 360ee (b) (3))
The FDA, in
commenting on the Congressional enactment, tells us,
commenting on the Congressional enactment, tells us,
“Medical foods are distinguished from the broader
category of foods for special dietary use and from foods that make health
claims by the requirement that medical foods
a. be intended to meet
distinctive nutritional requirements of a disease or condition,
b. used under
medical supervision and
c. intended for the
specific dietary management of a disease or condition.”
The FDA
FAQs further inform us,
FAQs further inform us,
“The term “medical foods” does not pertain to
all foods fed to sick patients. Medical foods are foods that are specially
formulated and processed (as opposed to a naturally occurring foodstuff used in
a natural state) for the patient who is seriously ill or who requires the
product as a major treatment modality.”
And the
Agency concludes:
Agency concludes:
“In general, to be considered a medical food, a product
must, at a minimum, meet the following criteria:
a. the product must be a
food for oral or tube feeding;
b. the product must be
labeled for the dietary management of a specific medical disorder, disease, or
condition for which there are distinctive nutritional requirements; and
c. the product must be
intended to be used under medical supervision…”
We therefore conclude from this exposition by the FDA several points of
note:
note:
(1) the Orphan Drug Act pre-empts the regulation of Medical Foods*;
(2)
products protected under DSHEA can be considered Medical Foods, and
(3) it is
appropriate for health care providers to recommend dietary management of
various nutritional and metabolic syndromes that are being identified by
advanced health care practitioners.
* Many physicians are concerned
about how they can integrate dietary supplements into their medical practices,
since various state medical boards still have some restrictions on the
inclusion of nutrition in the standard practice of medicine. Congress intended
the Orphan Drug Act as remedial legislation, to address the question of the use
of foods in medical practice. The Act in general is intended to exempt certain
remedies from previous legal restrictions, including Medical Foods. Congress
has legally pre-empted state medical regulations with regard to the “dietary
management” of medical conditions. This permits physicians to recommend dietary
supplements in ways that, before the Act, might have been restricted by state
regulations.
about how they can integrate dietary supplements into their medical practices,
since various state medical boards still have some restrictions on the
inclusion of nutrition in the standard practice of medicine. Congress intended
the Orphan Drug Act as remedial legislation, to address the question of the use
of foods in medical practice. The Act in general is intended to exempt certain
remedies from previous legal restrictions, including Medical Foods. Congress
has legally pre-empted state medical regulations with regard to the “dietary
management” of medical conditions. This permits physicians to recommend dietary
supplements in ways that, before the Act, might have been restricted by state
regulations.
Many of the fatalities or
other harms people experience during standard medical treatment are not from
the disease itself, but from the toll the surrounding circumstances takes on
the immune system, causing malnourishment and further sickness.
other harms people experience during standard medical treatment are not from
the disease itself, but from the toll the surrounding circumstances takes on
the immune system, causing malnourishment and further sickness.
This is where nutrients step
in to fight side-by-side with the patient and physician, by promoting overall
wellness, enhancing immunity and supporting metabolism. Simply put, healthier, stronger patients do
better when fighting their disease compared to patients whose health has been
physically compromised by cancer and the treatment for cancer.
in to fight side-by-side with the patient and physician, by promoting overall
wellness, enhancing immunity and supporting metabolism. Simply put, healthier, stronger patients do
better when fighting their disease compared to patients whose health has been
physically compromised by cancer and the treatment for cancer.
The type of medical
conditions for which dietary management is indicated include many conditions
and syndromes, including Wasting Syndrome, associated with serious diseases
such as cancer.
conditions for which dietary management is indicated include many conditions
and syndromes, including Wasting Syndrome, associated with serious diseases
such as cancer.
The standard applied to the
use of Medical Food is not the same standard as applies to the use of drugs and
invasive modalities, such as radiation and surgery. The standard for those
medical treatments is “significant scientific agreement” as mediated by FDA
approval of such standard treatments.
use of Medical Food is not the same standard as applies to the use of drugs and
invasive modalities, such as radiation and surgery. The standard for those
medical treatments is “significant scientific agreement” as mediated by FDA
approval of such standard treatments.
Congress, in determining to
create the separate regulatory category of Medical Food, instructed that a
different standard apply. That standard is”
create the separate regulatory category of Medical Food, instructed that a
different standard apply. That standard is”
“distinctive nutritional requirements, based on recognized
scientific principles… established by medical evaluation…”
Thus, recognized scientific
principles, as developed by nutritional science, provide the reliable and
competent substantiation for the use of high-potency nutrition as Medical Food
for the dietary management of medical conditions associated with disease.
principles, as developed by nutritional science, provide the reliable and
competent substantiation for the use of high-potency nutrition as Medical Food
for the dietary management of medical conditions associated with disease.
As a society and medical
community we are not currently at the point where we have a guaranteed cure to
cancer… however there is always hope. Year after year, millions of patients do
survive cancer and other debilitating disease.
By providing nutritional, wellness, and metabolic support, Medical Foods
help patients as a complement to their prescribed medical treatment. As your treatment partner and ally, the
Medical Food providers will stand with you and your patients, side-by-side.
community we are not currently at the point where we have a guaranteed cure to
cancer… however there is always hope. Year after year, millions of patients do
survive cancer and other debilitating disease.
By providing nutritional, wellness, and metabolic support, Medical Foods
help patients as a complement to their prescribed medical treatment. As your treatment partner and ally, the
Medical Food providers will stand with you and your patients, side-by-side.
The Medical Foods are
labeled as is usual for a food or dietary supplement, with an added label
providing the requirements to meet the Medical Foods standards: a place for the
physician’s name; the patient’s name; the statement,
labeled as is usual for a food or dietary supplement, with an added label
providing the requirements to meet the Medical Foods standards: a place for the
physician’s name; the patient’s name; the statement,
“For the Dietary
Management of ___________.” and “To be used under medical supervision.”
The Practice of Medicine is
both an art and a science. Modern medicine has at its disposal an entire
arsenal of treatment and therapy modalities. Licensed physicians are authorized
by both state and federal law to bring that arsenal to bear upon proper
diagnosis. State medical boards help define the standard of care. The federal
FDA helps determine what drugs and devices may be used for what treatments.
both an art and a science. Modern medicine has at its disposal an entire
arsenal of treatment and therapy modalities. Licensed physicians are authorized
by both state and federal law to bring that arsenal to bear upon proper
diagnosis. State medical boards help define the standard of care. The federal
FDA helps determine what drugs and devices may be used for what treatments.
Congress, in the Orphan Drug
Act, placed special emphasis on the use of nutrients, including dietary
supplements, for the dietary management of medical conditions. This management
is, itself, not a “treatment of disease” but is, rather, a “therapy that may
benefit” permitted under AMA Ethics Code Opinion 3.04.
Act, placed special emphasis on the use of nutrients, including dietary
supplements, for the dietary management of medical conditions. This management
is, itself, not a “treatment of disease” but is, rather, a “therapy that may
benefit” permitted under AMA Ethics Code Opinion 3.04.
In the case of Medical Foods
this distinction is critical. Medical Foods, as therapy that may benefit, can
be recommended by a physician and offered under medical supervision, to manage
medical conditions associated with cancer, for example, to assure optimal
clinical outcomes.
this distinction is critical. Medical Foods, as therapy that may benefit, can
be recommended by a physician and offered under medical supervision, to manage
medical conditions associated with cancer, for example, to assure optimal
clinical outcomes.
The Vitamin Lawyer Consultancy offers the Medical
Community incisive CME training, “Medical Foods and
Dietary Supplements In Medical Practice.”
Community incisive CME training, “Medical Foods and
Dietary Supplements In Medical Practice.”
© 2013
Ralph Fucetola JD
The Vitamin Lawyer.com Consultancy
http://www.VitaminLawyer.com
http://www.SOPcertification.com
http://www.NaturalHealthOptions.net
http://www.NaturalClinicalTrials.net
http://vitaminlawyerhealthfreedom.blogspot.com
Ralph Fucetola JD
www.VitaminLawyer.com
www.NaturalHealthOptions.net
www.VitaminLawyer.com
www.NaturalHealthOptions.net
Source: http://vitaminlawyerhealthfreedom.blogspot.com/2013/05/medical-foods-under-orphan-drug-act.html
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