The FDA, in cautionary mode, has come up with a meaningless nanotech threshold of 1,000 nanometers. The genius who decided on that number in a draft guidance on nanomaterial regulation has the biotech industry scratching its collective head over this new math.
As I wrote in my first nanotech column for PJMedia, nano is not any one technology at all. It is an enabling technology, the next step in the evolution of many different disciplines. The problem is that there is no definite dividing line between the “old” way of doing things and the nanoscale world.
There is a general agreement that nanotechnology begins at the level of 100 nanometers or less, but that has never been universally accepted and the number, itself, does not mean much. It always looked good on press releases, though, since it’s a nice round number and a good way of introducing the idea that different, counterintuitive, spooky, magical things happen to material at that scale.
That 100-nanometer limit is how nanotech businesses can promote the idea that they’re doing something futuristic-sounding and a way for nanotech detractors to find a dividing line beyond which “here be dragons” and push for regulation.
But, like the quantum world, itself, simply the act of observing it — or, in the case of the FDA, regulating it — has an impact on its development. And the FDA has multiplied that limit by 10 and came up with the 1,000 nanometer threshold.
Natalie Morrison of in-PharmaTechnologist.com reports that the Biotechnology Industry Organization (BIO) is worried that this new definition of nanotech would “mean pointless extra regulation.”
There are many materials in existing pharmaceuticals that already are smaller than this threshold, such as liposomes, emulsions and suspensions, that are already proven to be safe and may contain nanoscale particles, but are not the new, spooky, scary, magical nanomaterials that has regulators around the world worried.
It’s surprising, because the FDA has been studying nanomaterials for a long time and I’d have thought that they would at least know what it is they want to regulate, before they begin regulations. Not a good start to government oversight of nanobiotech.
Silly man.
The purpose of the FDA isn’t product safety, its to put up huge barriers to entry.
Natalie Morrison of in-PharmaTechnologist.com reports that the Biotechnology Industry Organization (BIO) is worried that this new definition of nanotech would “mean pointless extra regulation.”
Pointless? Hardly:
Bigger budgets & staffs at the FDA. More power for the FDA and its allies in the legal profession and NGOs. More cushy jobs at the regulated companies for retired senior bureaucrats.
And the beat goes on.
While I’m sure a lot of good people work at the FDA, it’s become clear to me in the last few years that not one of them is in any kind of management role. The FDA’s upper (and middle) echelons are staffed with a bunch of clowns. Let’s review.
This is the agency that wanted to take extra-strength Tylenol off the market because acetaminophen is in so many other OTC medications that there’s a chance people might overdose due to their own stupidity in not reading labels and directions. Some people depend on the existing dosage being available; this is a stupid move.
This is the agency that went ahead and banned CFC-based asthma inhalers after doing some very perfunctory studies deciding HFA was good enough for people with minor to moderate asthma. Well it isn’t good enough, because HFA comes with a lot of complications that makes it harder for people to use, and it’s not as effective a propellant which hurts people with severe cases. Let us not forget that HFA inhalers also weren’t available as generics at the time, raising the cost of treatment for people with low incomes–those hit hardest by asthma in the first place. This decision is not forgivable and the people responsible for it need to be booted out of government, and if possible out of the continent.
This is the agency that splits hairs between cheese and “cheese food”, yet still lets manufacturers get away with just listing “fragrance” in their ingredients, despite the fact that this covers more than a thousand chemicals, a third of which are known to be toxic to at least some people.
This is the agency holding up mass production of the lung flute, a product that could improve millions of lives and is only a “medical device” if you stretch the term to its absolute limit.
This is the agency that has turned drug trials, once reasonable, into enormous costly nightmares which have failed to improve either drug quality or the litigation burden on the industry.
This is the agency that’s trying to put the brakes on consumers doing at-home genetic screening.
I could go on, but do I really need to? The agency’s priorities have become so warped, they’re the last people I’d trust to keep nanotech safe, let alone encourage continued innovation in the field. History shows the FDA will not only fail miserably at both goals, but actively make the situation worse.