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FDA and Things that Might Go Bump in the Night


FDA’s everyday business requires balancing risk and benefit as these might apply to a particular medical product or a new food.  Occasionally, FDA is faced with a much larger responsibility: judging a breakthrough technology that could bring great benefit or great sorrow to humankind. Who can confidently know in advance which it will be?


Still, FDA must decide.  If they say “yes,” whole new industries and benefit may be created for patients and consumers. Or, the world and humankind may be subject to devastation. Today, the agency is faced with just such challenges in dealing with nanotechnology, genetically-engineered (GE) animals, and synthetic biology.   


Thirty years ago, FDA gave a cautious “yes” to the first biotechnology studies that eventually became important medical products to treat cancer, arthritis, MS and many other diseases. The world is a better place as a result.


In retrospect, the decision was right, but at the time, it wasn’t clear. Scary visions of mad scientists and technology run amok were powerful forces in the early days of biotechnology. In response, FDA took great care in setting up an appropriate regulatory environment.[1]


Not surprisingly then, FDA proceeds carefully when new areas of science and technology have great potential, but could also be the source of great harm.  


One such area is nanotechnology, “the science involving manipulation of materials on an atomic or molecular scale.” The agency is concerned because: “materials at the nanoscale can have different chemical, physical, or biological properties compared to their conventionally-scaled counterparts.” What we consider safe may not be safe if made from nano-particles.[2]


FDA responded in 2006 by forming a Nanotechnology Task Force, which still exists. It released an assessment and recommendations in 2007 that have guided FDA’s subsequent actions. These include the first draft guidance on nanotechnology in regulated products, published earlier this year. More extensive guidance is expected in the future.[3]


Yet another science with great potential for benefit, but also possible risks, is genetically-engineered (GE) animals. FDA has been monitoring this field for two decades and accelerated its efforts over the last 5 years as GE animal products have gotten closer to filing for approval.[4]


Currently, the agency is working (slowly and carefully) on GE Atlantic salmon that have been modified to grow faster.[5] If approved, it would also be the first GE animal to become part of our food supply. Opponents call it “Franken-fish” and allege that it will be dangerous to humans and the environment.


The agency has held hearings, sought feedback from advisory committees and tried to solicit all viewpoints. When it finally decides, it wants to be certain that the result will be beneficial and not harmful to our society.


While nanotechnology and GE salmon are well-along in the decisionmaking process, the FDA is only just beginning a similar cycle regarding “synthetic biology.” While “synthetic biology” can be defined a number of ways, it is generally considered to be “the use of molecular biological techniques and chemical synthesis to mimic and even redesign natural biological systems.”[6]


Synthetic biology raises the specter of artificial life (more mad scientists running amok?). The Presidential Commission for the Study of Bioethical Issues released a report in December 2010[7] and NIH is also deeply involved. FDA is watching, adding staff with appropriate backgrounds and planning carefully, knowing that product-specific questions about synthetic biology are coming its way.


As with biotechnology thirty years ago, FDA continues to make tough decisions about dramatic new technologies that can alter our way of life—for good or bad. Some fear will always be with us, if only because a wrong decision might be catastrophic. Past experience shows us the agency will be appropriately deliberative before coming to a conclusion.



 [1] http://www.fda.gov/AboutFDA/WhatWeDo/History/ProductRegulation/SelectionsFromFDLIUpdateSeriesonFDAHistory/ucm081964.htm

 [2] “There is a virtual consensus among scientists that the toxicology of engineered nanomaterials is largely unknown, and that toxicity data cannot be extrapolated from existing toxicology studies conducted on larger-scale materials.” http://www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/NanotechnologyTaskForce/ucm118910.htm


[6] Testimony of Dr. Anthony Fauci on synthetic biology: http://www.hhs.gov/asl/testify/2010/05/t20100527a.html

3 Responses to “FDA and Things that Might Go Bump in the Night”

  1. Harold Katz says:

    This article points out how great the services of the FDA have been to the citizens of this country……….and how conservative have been their actions……..and , perhaps, how under – appreciated and overly “dissed” they have been handled by the media.!!

  2. http://www.nature.com/news/2011/110928/full/news.2011.562.html. Efforts toward constructing guidelines for human testing and evaluation of studies done with nano-materials.

  3. Michael Vivion says:

    Clearly the FDA can’t be everything to everyone. There are simply too many dramatic changes in technology, both scientific and social for one organization to be a leader in all.. They do their best when they bring people together to talk, to explore issues. They are at their worst perhaps when social pressures dictate the level of acceptance or rejection of new developments–or new drugs for that matter.

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