The process of approving a generic drug was simplified
by the introduction of the Drug Price and Patent Term
Restoration Act of 1984 more commonly known as the
Hatch-Watchman Act after its main sponsors.
Generic Drugs are approved, as with all drugs in
America by the FDA or Food and Drug Administration.
Innovator Drugs undergo lengthy clinical testing to
ensure they are safe and do the job they claim.
Generic Drugs are tested differently, as the clinical
trial information already exists for the original
drug; all the generic version has to prove is that it
contains safe ingredients and is bioequivalent (works
in the same way) as the original drug.
Bioequivalence is stated by the FDA to be: “the
absence of a significant difference in the rate and
extent to which the active ingredient or active moiety
in pharmaceutical equivalents or pharmaceutical
alternatives becomes available at the site of drug
action when administered at the same molar dose under
similar conditions in an appropriately designed
study.” (FDA, 2003)”.
This means it releases the same amount of the same
active ingredient over the same time scale as he
original drug.
Once an existing patent has run out the applicant
submits an ANDA or Abbreviated New Drug Application
and bioequivalence tests are carried out. Once
approved the new Drug is added to the Approved Drug
Products List along with its bio equivalence
standards.
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This blue-green planet we live on, called Earth, as
far as scientist can tell, is the only planet that can
sustain human life. The atmosphere has the perfect mix
of air that we need to breathe and that plants and
trees need for survival.
The earth is the perfect distance from the sun,
allowing temperatures optimal for habitation of
millions of specials of animals and plants, and it
keeps the planet
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What is a generic Drug?
A Generic drug is produced once the patent of a new
drug has expired. It is the same as the original in
virtually everyway.
How are generic drugs regulated?
Generic drugs are regulated by the FDA and must be
tested and approved by them before production and
afterwards.
Is my generic drug made by the same company as the
brand name version? Possibly 50% of all generics are
made by the company which developed the original drug.
Are Generic drugs made in the same standard facilities
as brand drugs?
Yes all facilities must meet FDA standards.
Why do the branded and generic version of a drug look
different?
Trademark laws do not allow generic versions to look
like other drugs on the market so coloring, size and
shape etc may be different but they still act in the
same way as the difference is in the inactive
ingredients.
What is bioequivalence?
If a generic drug is bioequivalent to the original it
means the generic drug works in exactly the same way.
It releases the same amount of the same active
ingredient in to the blood stream over the same time
period as the original.
Why are generic drugs cheaper?
Due to increased competition between pharmaceutical
companies once a patent has been lifted on a
particular drug.
Where are generic drugs produced?
50% of all generic drugs continue to be produced by
the company, which held the original though at a lower
price due to competition. Some are made by developing
countries usually in cases where a drug is exempt in
that country from an existing patent in the West.
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You probably have noticed Earth Day on your April
calendar and you may have wondered what, exactly, is
it?
Earth Day came about after six years of effort from
then Senator Gaylord Nelson, who, back in the 1960s,
had the foresight to look at the long term impact of
pollution on the environment. He was instrumental in
getting his message out to college students, who took
this issue on with concern and enthusiasm for this
project. Earth Day became a National Awareness day on
January 20, 1970, with the date set for celebration as
April 22 of every year. In 2007, it is estimated that
one billion people recognized Earth Day in some way.
Internationally, Earth Day is celebrated at different
times, in approximately 175 countries. In the northern
hemisphere, it is observed in the spring; in the
southern hemisphere, Earth Day is observed in the
fall.
The purpose of Earth Day was to raise awareness of
environmental issues, promote education about the
issue, and to advocate for a healthy and sustainable
planet. Many schools have taken Earth Day a step
further to incorporate extended teaching of
environmental issues and observe Earth Week.
To find events in your area, or to get ideas for
helping you commemorate this special day, go to
www.earthdaynetwork.com. Get involved in helping in
your community, whatever the needs may be. Every city
has a park, street or stream that needs cleaning up,
and it takes only a few volunteers to make a huge
difference. Take the time to learn about how you can
help preserve this planet for future generations. They
will thank you for it!
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Generic drugs do not differ greatly from their branded
equivalents. All drugs are carefully regulated in
exactly the same way to ensure they contain the
correct amount of active ingredient as well as
suitable inactive ingredients and are produced and
manufactured in a similar way.
The generic drug must be shown to be bioequivalent to
the branded alternative i.e. releases exactly the same
amount of active ingredient over the same time scale.
The differences often lie mostly in the presentation
of the drug for example a branded drug may produce
pills which have a nice colouring and flavour, whereas
the generic version will generally contain little more
than the active ingredient.
There should therefore be very little difference to
the patient between branded and generic drugs and both
have to go through the same regulators. Generics have
a few advantages however over the branded
alternatives.
The branded drug is often the first of it
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Chlorofluorocarbons (CFCs) are a group of chemical
compounds that has been shown to have caused the ozone
holes in the stratosphere over both the North and
South poles. A seasonal hole appears above Antarctica
in September.
These holes in the atmosphere allow the sun
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Third world countries are often the most in need of
new medicines but patents prevent the production of
cheap generics, which could be one way of supplying
this demand.
As a solution the World Trade Organisation (WTO)
introduced legislation in 2003 which would allow third
world countries to let them know which medications
they require and allow companies compulsory licences
to produce generic versions of patented drugs to fill
this demand, the patent would still hold elsewhere
until expiration.
Some fear the drugs may be re-imported and sold back
to the west where seller would get a greater profit
rather than going to benefit those in need but strict
regulation that the drug be produced and imported for
humanitarian reasons only.
Another problem is ensuring prices remain low enough
for developing countries to afford, this requires a
market large enough to attract a large amount of
competition that will keep prices down.
There are many claims that large Pharmaceutical
companies are blocking efforts by countries such as
India to produce cheap generic versions of their
drugs. Drugs that are produced cheaply in these
countries are often imported to the west rather than
going to those in need in the countries of origin.
1 in 4 aids suffers have access to the HIV drugs they
need to stay alive and just 1 in 5 has access to basic
prevention services. There are currently 33,000,000
people living with HIV and AIDS.
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