The FDA: Federal Doofus Association

[Furunculus]

ah the FDA, how i love them.

i once spent a fortnight trying to understand their massively convoluted medical device acceptance program, the result was a twenty four page report for our venture capital partners into how our software-device could be 'processed' through the FDA.

great fun, in a masochistic way.

[Louis VI the Fat]

Bless the Western democracies for having health inspections and food safety agencies.

You eat and drink stuff, kids put it in their mouths. Thank God independent government run agencies provide the consumer with some protection. Much as the cowboys of this world would prefer for all that regulation to dissappear.

[rory_20_uk]

I agree that we need the FDA / EMEA.

However - drugs that would never have made it under current rules:

Paracetamol, Aspirin, Amitriptiline, Vancomycin, probably morphine and all related opiates and there are probably many others; penicillin has severe adverse events and that might have torpedoed it. Beta blockers can kill asthmatics, that might have been the end of them.

I think that far more drugs should be allowed to be used by clinicians with extensive guidance. All the drugs above do have features that clinicians and where appropriate the general public have to be aware of. But they are still extremely useful substances. There are probably thousands of others that would be of great use to a large segment of society which were not given licenses whose risk could be easily managed - as they are with these old drugs that were passed when conditions were far less stringent. If the barrier to market entry was lowered, drugs would also cost a lot less as there would be more competition and less costs to recoup.

[Furunculus]

Much as the cowboys of this world would prefer for all that regulation to dissappear.

who are they?

[rory_20_uk]

Probably Pharmaceutical companies, who are eeeeevil as they place a value on human life as they sell products at a profit, which is almost the same as killing those that can't afford them.

Since I work for a Consultancy which gets a large part of its business helping companies through the hoops I don't want too much to go

[Furunculus]

ours was a relatively simple one in the end, non dangerous with lots of predicate devices.

the ceo of the VC tried to pass of my report as his own insights back to my boss, hilarious!

[Louis VI the Fat]

who are they?

This sort of guys, the kind of ruthless cowboys the FDA's of this world are up against:

Formula for disaster
The politics of an unconscionable delay

Sep 18th 2008 | SHIJIAZHUANG
“QUALITY and safety are the foundations of social harmony,” proclaim posters at the headquarters of the Sanlu Group in Shijiazhuang, capital of China’s northern province of Hebei. Sanlu was until recently one of China’s biggest producers of milk powder. Now, dozens of people, many clutching infants, queue in the hot sun outside to return powder that could be contaminated with a potentially lethal chemical. The harmony of China’s consumers has rarely been so tested.

The safety scandal engulfing not only Sanlu, fingered as the main culprit, but much of China’s dairy industry, is an embarrassment to China’s leaders. In July last year, after widespread complaints at home and abroad about tainted Chinese-made food and medicine, the authorities executed a former head of the country’s food-and-drug safety agency for taking bribes.
http://www.economist.com/node/122622...ry_id=12262271

Democracies do well to maintain a strong, politically independent 'FDA'. Lots of regulation and intrusive oversight of what I and our children put in our mouths? Yes please!

[rory_20_uk]

That isn't so much about the rules, but the implementation of them. What happened here was also illegal in China.

[Louis VI the Fat]

It is what happens when an FDA is weak.

Corporations wish to have no food regulation. They wish to sell tobacco, without meddlesome agency insisting it is bad for people. They wish to sell all sorts of bizarre 'food' that make its consumers horridly obese, without government regulating against it. They wish to produce acidy tasting wine and label it with a fancy Bordeaux name, to sell abroad.
Or, in this case, adding drugs that mask the addition of alcohol in power drinks.

Against all this, consumers need to protect themselves. Producers for their part, need to spend their energy lobbying against regulation, and need to try to influence public opinion to believe that public protection of what your child eats is not in the interest of the public.

[rory_20_uk]

Certainly in the UK, there is widespread fear concerning such things as E numbers and perversely the thinking that anything "organic" or "natural" is good. Aflotoxin-laden peanuts, anyone? Liver cancer is "natural" as well...
One chap tried to overdose on as many E numbers as possible. His doctor was vastly more concerned with his intake of salt and saturated fats (both "natural"...)

Yes, there are some exceptions to this rule. Tartrazine isn't good for a subset of adults and children (nor is a vast amount of simple sugar which is arguably worse - but is "natural").

If caffeine only hid the effect of alcohol I'd agree it should be banned, but this is not the case. The alcohol content is not hidden, which again would be a problem.

If the wine is not toxic and people buy it then fine. Surely the point of wine is to be consumed and enjoyed. If someone was cooking a meal and someone added an ingredient and it improved the meal, people would be happy and they would be lauded. Why is there a difference when this is wine?

What children eat should be determined by their parents, not for the government to ban anything that might be bad. For example, Salami is very fatty, and I have a couple of slices generally less than once a month. Should it be banned in case children might be eating one a day? Eating one avocado is good for you. Eating three a day isn't. Can we legislate against that as well?

[Beskar]

who are they?

The ones who used to paint sugar sweets with lead paints because it makes them very vibrant, which is very appealing to kids. This is the stuff they used to pull before Food/Drug Safety bodies were around.

[rory_20_uk]

I think Chromium was more likely, at least for those lovely yellows and greens.

But although I'd not question their importance (lash lure was another key milestone - putting basically tar derivatives on eyelashes that led to scarring, blindness and even death) I still think that at the moment they're blocking too many new things.

[Beskar]

I think Chromium was more likely, at least for those lovely yellows and greens.

I know they used to use lead tetroxide for the red. It might be chromium for other colours.