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altsys

Having a centralized government agency isn't the only way to achieve the safety and efficacy aims of the FDA. One could imagine alternative systems that would boost safety and efficacy, lower cost, and decrease time to market. Higher education, for example, is accredited by regional non-profits that are in turn recognized by the Department of Education. Expecting consumers to police their own drugs wouldn't be reasonable, but it's not unreasonable to question whether the FDA should continue to exist as-is.

Not Larry Sabato

The difference in education is a) there aren't a lot of close calls on schools that should/shouldn't be accredited, b) other than Brian Moran's day job most colleges are not "for-profit" and c) you don't die the day you attend a bad college.

As someone just said to me on twitter, any sort of private consumer screening would be overwhelmed by the money that drug manufactures would pay to move drugs to the market faster.

Brian W. Schoeneman

Amit has got a point - the FDA, as a regulatory agency, needs some serious reform. The drug approval process takes far too long, and some of their regulation leaves much to be desired. Instead of spending their time trying to devise new cigarette packages that won't make an ounce of difference, I'd rather see them take those resources to focus on things that matter.

FDA needs serious reform. Ending it, however, isn't the answer.

Not Larry Sabato

Brian, why do you say the drug approval process takes too long? Isn't part of that process making sure there aren't *long term impacts* of the drugs?

GNProgressive

^pwned

Besides, I broke my nose 2 years ago and the doctor gave me cocaine as the local when he reset it. Cocaine is honestly a wonder drug for medical procedures. It is, or was, the anesthetic of choice for all ear, nose, throat, eye, and facial surgeries.

Brian W. Schoeneman

Generally the process, as I understand, it determine if the drug is safe only lasts about a year. The problem is when the drugs get bogged down in the regulatory process. It is ridiculously expensive to get drugs to market.

Plus, you've got drugs that have been cleared in Europe and Canada that haven't been approved in the US. There's no reason why we can't have some kind of international reciprocity with countries we approve to get drugs to market faster.

change

Please don’t let us “ignorant” consumers choose what we believe may be best for us…
Make sure Uncle Sam puts a check mark on our “cures, “ even if we are dead by the time he gets around to it….

Who’s life? Who’s choice???

Not Larry Sabato

Brian, I'm not opposed in theory to reciprocity, but you do create problems there if the group of countries becomes 10, 15, 20 large as drug makers could pay off officials in any *one* country and suddenly they could bring their products to market in the U.S. There's also nothing illegal about crossing a border if you want to buy something legal in Canada for example. Buses of seniors used to do that to get lower priced drugs.

The irony here is the same people arguing against the FDA involvement here are basically the same people in favor of "tort reform" and capping damages in lawsuits. So they would allow dangerous drugs on market that have not been fully vetted and then limit your ability to sue the makers when they killed or injured someone by selling a faulty product. Truly a "Somalia" vision of what America should be.

truthteller

Change, and I'm sure the consumer is fully equipped to regulate food safety as well, right? If you think it was snark, you are correct

local gop

Change,
Don't be asinine, the point is that not everyone is equipped to make a decision about their health if agencies like the FDA go away. My grandfather for example is pushing 80 and his mental health is deteriorating. Do you think I am ok with him making his own medical decisions? No. There are a lot of drugs out there and people can't possibly take the time to become experts in each one and vet each one in a reasonable amount of time. It has nothing to do with taking away freedoms of choosing your own course of treatment so don't make it out to be like that. The government still needs to promote the general welfare, but the processes can be made easier and quicker.

frankoanderson

If you think the invisible hand of the free market will solve all our problems and self-regulate prescription drugs, then Big Pharma may have a position for you in their lobbying department.

Jack

"Who’s life?"

Jesus said, "I am the Way, the Truth, and the Life."

Spock

So, Jack, all can be solved with myths and fairytales?

Gretchen Laskas

I certainly do not wish to see the FDA abolished (and I agree that the cigarette labels are stupid.) But there is no denying that we are dealing with a terribly flawed system -- created both by the insistence that we as a society can protect someone from every possible conceivable danger (a nice liberal notion?) combined with one of the most aggressive economic machines pushing self-diagnosis upon individuals that just so happens to correspond to the often expensive drug of the month. (A nice market-based conservative notion?)

You Socialist

Maybe the FDA needs to be reformed, but a free market FDA sounds like the new members of Congress' pledge to cut taxes and balance the budget - I don't think it'll ever work.

I'd like to see some examples how other countries' FDAs operate. But I'm assuming you're probably all thinking about European countries and Canada. Correct?

Now if my memory serves me correct - aren't they all practicing socialized medicine anyways? How could we have agreements with those type of countries? Could we trust them?

Not Ben

What entity do knowledgable consumers trust more -- The FDA or Consumer Reports?

truthteller

So Not Ben, are you going to give Consumer Reports enough federal dough to research and write up all the drugs out there? You know I'm pretty sure they have finite resources and can't expand their scope to cover all pharmaceuticals without a serious investment of resources....

Mark

Ben

As an attorney who has focused on FDA-related areas for over 20 years, please let me point out the problem with the article that formed the basis for the blog.

FDA does not review individual herbal products before they are offered for sale. Herbal products are considered to be foods, not drugs. Herbal products are generally marketed as dietary supplements which do not go throught a pre-approval process.

The herbal tea product violated other parts of FDA requirements, but FDA did not "approve" the tea.

In this case, the supplier is to blame, not FDA.

Steve Vaughan

Some of you seem to think the FDA was created just to hassle the drug companies. We tried an unregulated drug market. And compnanies were willing to sell poison and call it medicine.

jack

Just answering the question, Spock.

change

local gop,
You should take care of your family to avoid issues; or if you like you should sign him up for Obamacare and a group of “political doctors” will tell him what he needs to go to sleep peacefully and not be a burden on the system…..
If anyone thinks the FDA solves all ills you should watch the commercials from the ambulance chasers.

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