The U.S.
Food and Drug Administration (FDA) published yesterday (April 9, 2012) in
YouTube a video entitled "Innovation Pathway at FDA."
Personally
I really like the video and especially the positive message it conveys. Here in
my blog I give my Sincere Congratulations to the FDA by the video, and
especially by the highly positive message it sends.
This
message is a very strong set of clear positive signs of optimism, hope,
constructive spirit, innovative spirit, proactive and highly dynamic attitude
announced to the world.
As far as I
know, FDA is among their counterparts around the world an entity with an
unquestionable credibility and effectiveness. My perception is that FDA is the reference with respect to regulations in the areas it is responsible.
However,
FDA has been discussed in the most recent years with destructive attacks and
comments. For example:
- Apparently innocent criticism;
- Explicit accusations of not updating (or updating very slowly) its regulations when confronted with new challenges brought by an emerging new reality which includes the requirement for innovation and new and emerging sciences and technologies;
- Unfounded conspiracy theories which proliferate throughout the Internet;
- Sensationalist news trying to undermine the credibility of this organization.
Some of
these attacks had eventually caused some abrasion on the image of FDA as an
organization.
Therefore,
FDA needed to launch a campaign containing a very strong message of positivism,
optimism, hope and confidence addressed to the world.
The reality
has changed in recent years. It is a fact that reality has changed and will
change constantly. Thus, FDA and similar organizations must adapt to new
realities, new paradigms and the requirements they entail.
But what
really happened in the most recent years that really made this change and therefore
lead to attacks on FDA and similar organizations, and consequently the release
of this video?
Several
changes took place.
Firstly,
the counterfeit medicinal products began to proliferate in practically the
entire world. The counterfeit drugs have become a real scourge in terms of
public health and a threat to the pharmaceutical industry.
Moreover,
nanoscience and nanotechnology grew and developed at an impressive speed.
Similarly,
nanomedicine grew and developed at a considerable speed. Nanomedicine gained
critical mass and is proving to have potential to contribute constructively to
improve medicine and biomedicine. This is just the beginning. Many more
discoveries are to be announced and to a higher speed.
Likewise
also grown and developed the applications of nanotechnology-based products in
the food & beverages sector. This includes not only food, but also
packaging and manufacturing processes.
With the
fast development of nanotechnology with applications in medicine (nanomedicine)
and in the food & beverages industry, have also emerged real risks
associated with toxicity, both environmentally and in terms of public health.
These risks are directly related to nanoengineered nanoparticles (nanoparticles
intentionally modified by humans for the fulfilment of certain specific
purposes). Scientific studies show that these nanoparticles (in opposition to
naturally occurring nanoparticles) present the greatest risks to the
environment and public health, with respect to toxicity.
Anyway,
regulating with quality and adjusted to the real needs of today's society
(especially regarding nanotechnology-based health products and food &
beverages) is an enormous task, having a complexity of unique proportions. I
would say, of historic proportions. It is a complicated challenge and only give
good results if integrated, coordinated, standardized and implemented with much
committed collaboration with different players, such as innovators, scientists, R&D institutions, universities, industries, health professionals, consultants, IT professionals and many more players.
It is
notorious that the video puts much emphasis on technological innovation and
collaboration. It is an extremely strong reinforcing of confidence message. In
my opinion this message is fully justified, to calm down conspiracy theories
and media sensationalism.
This version was published on April 11, 2012, since the original one was removed.
In these
areas of science and technology, the worst that can happen is a lack of regulation,
which causes a gray zone, providing opportunities to bad professional
journalists to make pieces of questionable quality, thus generating fears,
suspicions and unfounded conspiracy theories.
FDA is
really working hard. I did not learn that with this video. I had already
noticed with various press releases issued recently, mainly during the year of
2011 and during the current year. This video just confirmed what I already
knew.
However,
the ordinary citizen, who is not involved in these matters, did not know. Through
this video, the ordinary citizen gets to know.
The tasks
that FDA faces are of odd proportions and dimensions absolutely gigantic in the
history of our civilization. I can only wish the greatest success to FDA
and give them strength.
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