Given the complexity of the drugs, the body and the interaction with other medication I'm impressed it's only 1 in 3 particulary since as mentioned down thread only 1.3% get taken off the market (1 in 77).
It's really hard to tell what works and what doesn't. Drug companies spend tens or hundreds of millions on a drug even before it gets to FDA testing, and most still fail final clinical trials. Most drugs just don't do what the developers think they will do.
None. FDA approval isn't required to manufacture, sell, or purchase drugs. It's only required for companies that want to make marketing claims about the ability of drugs to treat various illnesses and conditions. As long as the drug you want isn't scheduled by the DEA, you're free to go online and order however much you want.
I can be swayed , but i do subscribe to the concept that there is an availability bias in FDA approval: the fda has the incentive to be overly cautions, because punishment hurts fda, but banning potentially good medicine does not cause FDA any problems.
That, and the potential of regulatory capture make me dubious of any positive claim about the existence of the FDA.
Sure, if you want to order your meds from online pharmacies based in India and Vanuatu, you can (and I personally know people who order cyproterone acetate from these pharmacies because it's the best oral anti-androgen in existence but hasn't been approved by the FDA mostly out of laziness/cheapness), but you can expect to pay a lot of money. Oh, and you run the very small risk of having your meds confiscated by customs (they legally can't take action against you, because buying isn't illegal, but they can confiscate it because selling is illegal), but thankfully the government only has the resources to actively confiscate meds from online pharmacies one week per year (look up "Operation Pangea").
Even for a drug that's approved by the FDA, you'll be paying more to order the meds online than you will to go to a doctor, pay for the visit out of pocket, and have the prescription filled at Walmart (I have personal experience with this: because it's a pain in the ass to find doctors who will treat trans people, a lot of us start off ordering our meds from online pharmacies before we find a doctor, and it's not a huge deal because dosages are standardized, you can order private blood tests from certain labs, and official clinical guidelines are freely available for download -- but it's always cheaper to go through a doctor even if you're self-paying, the problem is finding a doctor in the first place).
Source? I'm pretty sure this is only true if you advertise the product as being for human consumption. The U.S. has basically zero restrictions on selling random chemicals. C.f.:
http://www.pbs.org/newshour/updates/it-could-take-centuries-...
That said, if you start claiming your "chemical" has health benefits, then the FDA will get all over you for making unproven health claims.
The one exception is the supplement market in the US. If you can trace the chemical back to a natural source, then you are allowed to sell it, and I believe make claims based on what data is available, but you still can't make unproven claims.
It's a jungle of regulations out there.
This is why is cracks me up when people want to tie public services (e.g., food stamps) to drug testing. Imagine how many (white) middle class kids would be denied school is their parents' blood/piss tested positive for drugs they had no script for. Lol
Drug testing in the US is insane.
P.s. Script and illegal use of prescription opioids are the gateway to street opiods (e.g., heroin).
A great many drugs don't qualify for that.
> A more interesting question would be how many would have a significant safety issue without FDA approval.
tl;dr
> FDA approval (LOA) reveals that only 9.6% (n=9,985) of drug development programs successfully make it to market
The FDA strikes a good balance I think. Its never going to be 100% successful but it does screen out many dangerous drugs.
Given the commercial pressures on a new drug, vast expenditure I'm happy another body is in the loop.
The safety of US made nutraceuticals is also a testament to that fact although they have become increasingly regulated by the FDA and FTC despite a lack of prominent examples to back the need for further regulation.
Nutraceuticals are a great example of the problem: they're safe because they're bogus and don't do anything. But because they're not regulated people waste tons of money (and suffer because they don't take drugs that do actually work). The
That said, most are not in health business. They are in the manufacturing, distribution, and sales business. That is what they do. And they will act in ways that fulfill that model. That's just human (business) nature.
But that's always the case. The OP is about an amount of error the FDA is accepting. The only question is the right amount of acceptable error.
And we wonder why healthcare is so expensive, obesity aside.