The FDA Kills

How government regulations raise prices and stifle medical innovations

It would be nice if politicians and regulators left us alone. But they don't. They always want to do more. Recently, there have been shortages of some medicines. Cancer patients can't get drugs they need. Why not?

One reason is that a big drugmaker shut down for a year in part to meet Food and Drug Administration rules. The FDA makes it so expensive and difficult to sell drugs that there isn't an eager pack of companies rushing to the fill the gap. The free market would provide that, but government intervention, such as low Medicare reimbursement, strangles it. So people suffer.

Does the FDA say it's sorry for its part and back off? Of course not. Regulators almost never do that. In fact, the FDA wants more power.

It wants to regulate how your doctor uses his smartphone. I'm not kidding! The FDA wants the power to approve mobile medical apps that let doctors monitor patients' vital signs over their phones. As one doctor put it, "Even though I'm away from the hospital, I can still look at ... real-time wave form data just as if I were at the patient's bedside."

Sounds great. It makes doctors more efficient. But the FDA basically says, "No, you just can't put something on your phone if it's a medical device. What if it doesn't work right? We have to approve it first."

That caution makes sense to people. Our first instinct is to say, "I don't want someone getting rich off a device that might not work right. It might kill me. I want the FDA to make sure everything is safe and effective."

But lawyer Jonathan Emord says our instinct is wrong.

"It is wrong because these regulations are costly, burdensome, and they prevent essential medical apps from getting into the marketplace," Emord said.

But an app might kill me.

Emord said that although many medical apps are available, there is "not a single complaint that someone has died or been seriously injured by a single one."

But what's the harm in running apps past the regulators?

"There is so much corruption at the Food and Drug Administration ... so much anticompetitive bias."

The FDA takes bribes?

"Almost," Emord explained. "If you feather the right nest, you will do well for yourself after you leave. This is well known."

This is known as "regulatory capture." A regulator makes it tough for some company's competitor and then gets a job with the first company when he leaves his government job.

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  • ||

    YAY FINALLY A BOOK THINGY COOTER CAN UNDERSTAN'! THANKS STOFFEL!

  • Jay S.||

    But, but, but toxic sulfanilamide!

    (never mind Vioxx, Fen/Phen, etc.)

  • Comment Tater||

    When I read Stossel I hear Andy Rooney.

  • AlmightyJB||

    That's funny. I hadn't thought about it but it's true. He seems to have become more animated over the years. I've always like Stossel though, can't really say the same about Rooney.

  • Edwin||

    "But lawyer Jonathan Emord says our instinct is wrong"

    The instinct isn't wrong, it's just been taken to insane levels.

    I build houses. I have to go through permits and inspections through every step of the process. Permits per house add up to lik $5,000. But ultimately as long as I do these things, I can build a house no problem.

    The way drug making and medicine is, if my industry were like that, It'd be $40,000 per house in gov-permit-whatever expenses, I might not even get to build a house if my "Certificate of Need" is denied, I'd need inspections not just for framing and fire and plumbing etc., but for every freaking door and railing, along with paperwork to go along with each. Foundation inspection would involve an inspection for every course of block. Every house would have to have a zoning impact statement and environmental impact statement. Etc. Etc.

    It's be lunacy. And that's where the medical industry is.

  • Richard Head||

    Good analogy

  • ||

    Edwin: It used to be $5000 for the FDA too. Just saying.

  • Edwin||

    Luckily here in NJ there's good 'ol corruption and just the desire to keep up with the joneses to keep the regulations reasonable

    And anyway, the trend has been towards more urban/dense development, which I prefer anyway. I'd rather build something in our small cities near the trains for real people who want to live in the world than another McMansion for some asshole who wants to act like he has more money than he actually does or another socially inept obnoxious breeder who was only lucky enough to be born to rich parents

  • Mr. FIFY||

    Wow, Edwin... you're hittin' the wealth-envy sauce pretty hard today.

    BTW... "breeder" is a word militant gays use to deride straight people. Just sayin'.

  • Edwin||

    you ever actually known wealthy people/family people? The kind we have here in New Jersey are annoying as fuck. I've spent my whole life with them. They're all guys who married the first girl who fucked them (as Doug Stanhope put it) because they can't fucking normally socialize with normal ass Americans, and spen most of their time with their family, no close friends, just people they do stuff with.
    They're mostly foreigners and weird as fuck, because their culture is whackadoodle. Ever wonder why the middle east is so fucked up? Because it's so fucked up, they're all fucked in the head, their culture breeds it.

  • R||

    So, you decided to add straight up racism and xenophobia to your wealth-envy' rant? Damn, you're firing on all cylinders today. What's next, a remark on how the Jews control Wall Street?

  • Mr. FIFY||

    Edwin usually doesn't add those extra nasty bits, R, but in general he's just a foul-tempered prick.

    Didn't know he was a rich-hater, though. Maybe he's turned socialist on us since his last visit.

  • Edwin||

    how is that racist? Do you have any idea what you're talking about? If you had some fucking sense, you'd notice I said "I grew up with these people", as in, they're my family. So are you saying I am racist against my own race? That's retarded.

    And FYI one of the horrible things about them is that they're racists and anti-semites. Anybody from any country between Morocco and India thinks Jews want to take over the world. And they're racist against black people, too, which is amazin. They don't even have black people in their country. Do you know how hateful you have to be to go into another country and just suddenly start hating an entire class of people you've never even seen before?

    Not to mention in general that your retarded implication that reality can be "racist". I've grown up with this/these cultures, and everything I said comes from personal experience. They are fucking weirdos with an extremely tenuous grip on reality and the social skills of a screaming pig. Their entire "minds" are nothing but a conglomeration of very simple memes.

    Think of Khan from King Of The Hill, or the family from My Big Fat Greek Wedding. You know when people write stuff like that, they don't just make it up from whole cloth. That shit comes from personal experience of the writers. You think those characters/movie are exaggurations. They only slightly are.

  • ||

    No, that's $5k that is wasted.

    You would build sound houses regardless because you are a professional and because you want more business and you don't want to be sued.

    That $5k doesn't buy the consumer anything. The government is not liable if they fail to ensure a safe home.

    But it does protect does protect builders from some competition. It does protect builders from some tort. (hey it was inspected!) And it certainly creates sinecures for bureaucrats.

    If I wanted that level of insurance that a house I contracted to have built I could pay a lot less than 5K to have your work insured, and if if there was a problem I would actually get a payout.

    There is zero economic justification for that or the FDA.

  • Fist of Etiquette||

    Voluntary FDA approvals. If I don't want to limit myself to medication and procedures approved by the feds, that should be my choice. Same with any government certifications.

  • Edwin||

    problem is, with liability handled by the courts, it is already up to the government and always will be. There in reality is no such thing as "No government approval"

    that's just one of a few very important reasons that some technocratic regulation is necessary. My boss even says he likes the inspections and permits we have to do for houses.
    But of course, again, the FDA is ridiculous.

  • Fist of Etiquette||

    Liability for harm would still be preferable to regulation of safety. Many medical practitioners would opt to limit themselves to FDA-stamped products but some would not, and those could be sought out by the individual wanting to exercise choice.

    As a consumer I would opt for the permitted construction and probable higher cost, but that's my choice.

  • ||

    Make the FDA liable for harm done by impeding the market. It would be hard as hell to prove in most cases, but it would be avstart at counteracting the "nobody ever got in trouble for NOT approving a med" culture that clogs the system.

    Of course that would mean beginning to hold the State responsible fot its action and inactions. We'd be able to hear the squeals of outrage in the nest galaxy.

  • Edwin||

    a dual-choice system would be reasonable. But I promise you no developer would choose the courts. The courts are the worst clusterfuck imaginable. Anarchies have more consistency and predictability than our courts.
    Again, like I said, my boss even says he likes the permits and inspection process

  • ||

    Anarchy is order; the monopoly justice we have is chaos.

  • Ziggy||

    Maybe because your boss knows the extra hoops to jump through, holds down new competition.

  • BelowTheRim||

    Edwin, your boss is probably cozy with the regulators!

    No wonder he likes them. They rubber stamp your operation and delay or deny w/out cause approval for your competition.

    It's not rocket science, only government science.

  • Edwin||

    no, he likes them because they provide plenty of paperwork as evidence, that is automatically "backed up" at the municipal building (never know when your office could flood/fire etc). Such paperwork is useful in court. Judges also look upon the government inspections more as a sign that you did evrything (and I suspect more so than they would most other forms of "approval" were there no gov-run inspection systems)

    They also provide us a way to make sure our subs aren't screwing us over. THEY'RE the experts, you don't actually need to be a huge expert in construction to be a developer, and most developers really aren't.

    I guess part of the reason is my boss is kind of stupid, so he doesn't really understand law too well, so to him it seems like a clusterfuck. Not that it isn't (it is), but his lack of the ability to understand law makes it seem worse to him. (and he does indeed lack the ability. After we took realty classes and learned about anti-discrimination laws, he somehow thought it was illegal to discriminate against fatties. I tried desperately to explain to them that there's nothing in law written like that and all such cases rested on gender or age or other discrimination with a fatness element to it, but they just couldn't understannd. So yeah, he has a pretty bad conceptual understanding of law and other thingsd)

  • ||

    If the FDA stamp is optional, and it doesn't have a legal monopoly on certifications and it is self funded then ok.

    But then it just becomes a private certification company.

    The taxpayer should not be forced to fund services he has no need nor interest in. If I trust my drug manufacturer why should I subsidize the FDA for certifications I don't use?

  • Metazoan||

    This is without question. I know the man who invented Lipitor, and he informed me that for the final approval, they needed two tractor-trailors full of documents to submit to the regulators.

    1) Imagine how much time that took to fill out.

    2) Imagine how much time it will take for the regulators to jack off pretending to read it.

  • AlmightyJB||

    Yeah, that's the thing. All of that additional time and cost. At the end of the day does ,the FDA makes us any safer? Probably not.

  • Metazoan||

    Right. Especially for drugs for terminal illnesses like chemo. Just let people try it if they want to- it's not like a stage IV cancer is going to magically regress in any specific segment of the population. If it goes away substantially, one could attribute that to the drug.

    I think the way the FDA mandates trials for these types of drugs is actually quite unethical, and I know some biostatisticians actually agree, pointing out that we can do without that.

  • Edwin||

    HOLY SHIT.

    OMG this is the golden example if you can confirm this. It's the perfect example of what's fucking wrong with our medical system

  • ||

    A good bureaucrat never finishes early.

  • ||

    The Army of the Dead from LOTR was actually a horde of FDA victims. They should come back and fuck up the federales.

  • AlmightyJB||

    It sucks we have to wait another year for The Hobbit movie.

  • ||

    Yeah, that blows pretty hard. What with the great fantasy I've recently discovered with A Game of Thrones and its TV adaptation, I've got a new enthusiasm for high fantasy. I'll probably rewatch the entire LOTR trilogy this weeks, HBO's Game of Thrones, and start playing either Dragon Age: Origins, Oblivion, or Neverwinter Nights 2 (because it has CLOAKS, BIOWARE -- CLOAKS).

  • anon||

    +1 for Game of Thrones.

  • ||

    I was surprised by how good the TV show turned out to be. The first season was awesome, but the one thing that would make it better (if, of course, the next five books themselves actually feature more action) is an increase in the per-episode budget so that we get kick-ass, high-quality, epic battles in season 2 and beyond.

  • MountainMedic||

    Unfortunately, without significant tort reform, the physicians are put into a poor position when prescribing Rx/ devices that have not undergone "approval" by somebody. They just can't assume the liability. The patient who has stage IV liver cancer is prescribed an un-approved drug. Patient develops a headache of which the subjective pain goes "through the roof" while it's presentation is exaggerated due to the chronic anxiety the cancer patient has. Physician is now forced to take pt to CT to check his head. Radiologist confirms very small brain bleed. Bleed is attributed to Rx, not the fact the liver cancer guy has a coagulopathy due to the cancer that causes spontaneous bleeds anywhere and everywhere. Physician is sued for every dime he and his insurance company has and he ends up flushing his 14 years of Med School education down the toilet with yesterdays breakfast.

  • ||

    I imagine ambulance chasers fucking love the FDA. All they have to find is one out of a few thousand documents where the hospital didn't dot the 'i's and cross the 't's correctly.

  • Mr Whipple||

    One reason is that a big drugmaker shut down for a year in part to meet Food and Drug Administration rules.

    It is still difficult to get Pepcid Complete® because the FDA shut down a Johnson & Johnson™ factory. Even the generics are hard to find because it created a shortage that the generic manufacturers couldn't fill.

  • ­||

    Not trolling or trying to be a wiseass, but try baking soda. Chronic heartburn sufferer here, and it actually works better for me than Pepcid, et al.

  • Krugnuts||

    Corporations not being able work within a sensible regulatory frame work equals market failure. Time to nationalize the pharmaceutical industry. Since it is very difficult to successfully sue the government for negligible deaths , they'll be able to provide more efficient advances in medicine.

  • anon||

    More efficient deaths too, as there simply won't be any medicine in viable amounts!

    Win/Win solution. All those old people vote Republican anyways.

    /sic

  • Dingus||

    The FDA is part of the clusterfuck network of drug companies and regulatory agencies (D.E.A. most prominently) that have made it incredibly difficult for me to get my adderall Rx filled. They're all pointing fingers at each other, but the bottom line is that the D.E.A and F.D.A's inflexible restrictions on raw product is making it impossible for drug companies to continue manufacturing the drug. It doesn't help that only one company is actually allowed to produce the raw product, and suprise surprise they also happen to be the company that produces the more expensive brand name drug! Their response to the situation has basically been "well sucks for you, have to wait until next year to get your meds." If the government wasn't regulating the drug in such a heavy handed manner, other companies could step in and fill the void. You never see a shortage of tylenol for example.

  • Edwin||

    I'd like to add it's fucked up when a regulatory system is so bad Mexico becomes a better place to get your service/products

  • ||

    The FDA's harm cuts both ways. The FDA also keeps harmful drugs on the market. An example is Yaz, a birth control pill that causes blood clots more frequently than do other such pills. These clots can be deadly, as was the case with my sister who died two years ago at age 35.

    The FDA should know the danger of this drug but, like any bureaucracy, it is slow to react. Meanwhile, Yaz has the FDA's approval and millions of women use it for birth control and other reasons. If the FDA were not a gatekeeper, dangerous drugs like Yaz would be forced out of the market more quickly. New drugs would take their place or old standbys would regain their popularity.

  • Joe||

    We don't even know who the victims are.

    Ok, raise your hand if you know someone who has had prostate cancer within the last 8 years. These are the people that getting screwed by the FDA.

    During the last 8 (9?) years there has been a treatment used in Europe and other places where they burn the cancer out from inside the prostate by crossing sound waves. Nothing else is damaged in the process and the men can go on to lead normal healthy lives. All the treatments currently approved by the FDA eventually lead to problems such as impotence, incontinence, etc.

  • JoshEpi||

    As someone who treats prostate cancer in the US the method you describe is not ideal. It is certainly not widely adapted as with cryotherapy there are no advanced mechanisms for identifying the extent and side effects can be extremely disabling.

    But that is neither here nor there. We would be better with more options.

  • The Derider||

    Part of the problem is the patent system and "intellectual property". If you develop a new drug you go to the FDA to get your four years of monopoly power.

    I'm not sure how eliminating the FDA solves this problem.

  • ||

    What, exactly, would be the benefit to blowing millions of dollars developing a drug if there was no actual competitive advantage in marketing it thereafter? The scare quotes around "intellectual property" in your post are just bizarre.

  • Edwin||

    indeed, FDA regulations mixed with a lack of intellectual property rights would fucking DEMOLISH any and all drug research. Fuck, even colleges do it for the patent rights to make the money

  • ||

    So, no need for any actual evidence of the supposedly crippling effect of the FDA, just throw out some claims and quote some lawyer that agrees. Seriously? I'm rarely impressed by Stossel's journalism, but this is absolutely pathetic. If a couple anecdotes is sufficient, anyone doing a bit of research can easily find counterexamples. A legitimate analysis and examination of the pluses and minuses of the FDA would be great, but it's sure not something found in this article.

  • ||

    "Useful HIV drugs were available in Europe for years before the FDA approved them for use here."

    Of course they were useful drugs, in hindsight. Just because somebody says a drug is useful by no means should we start giving it to our citizens by the thousands. The precautionary principle saves more lives than those lost by waiting for the bureaucracy to run its course.

    And Edwin, if we lived in a place that did not require permits to build things buildings would fall apart because people wouldn't build them up to par. Look at Haiti from the earthquake. One of the reasons their buildings and infrastructure were so devastated was because the zonings and permits were not properly enforced.

    Chile, on the other hand, experienced an earthquake of similar magnitude, but their government had done a better job of regulating the people who built the houses, and ultimately lives, homes, and families were saved because the structures were built up to standards.

    Also while I was in India buildings literally fell apart, killing people, from nothing because they had not followed regulation. No earthquake, no storm. Just a faulty building that was built free of regulation and permits.

  • Edwin||

    I never said there shouldn't be any building regulations. As a matter of fact, I specifically said there should be. Try actually reading thoroughly once in your life.

    What I said was the medical industry's regulations are insanely numerous and onerous, and used my experience with building to construct an example.

  • Another Phil||

    Of course they were useful drugs, in hindsight. Just because somebody says a drug is useful by no means should we start giving it to our citizens by the thousands.

    Who is this "we" you speak of? I should decide what medicine I take. Not you, or the collective, or some bureaucrat. If I understand the risks, what possible objection could anyone have to letting me assume them? Oh, yeah, you don't want the responsibility for yourself, so the hell with the rest of us.

  • ||

    Prior to a treatment being thoroughly scientifically vetted, you can't understand the risks. Are you really too dense to understand that?

  • Another Phil||

    Way to beg the question. The oblivious smugness is precious too. You assume that only a government bureaucracy can scientifically evaluate study results. Then you assert that without that agency, I can't understand the risks. Perfect circular logic. What a maroon.

  • Fist of Etiquette||

    A repeat. I knew it.

  • Marc Jacobs||

    Speaking of the U.S. fashion industry, a handful of the few big-name designers. However, you must not forget Marc Jacobs. His designs are generally free, but the product is designed themselves. For example: Marc Jacobs Handbag, Marc by Marc Jacobs Handbag. In fact, his decks Marc by Marc Jacobs also stand out in the fashion industry. Marc by Marc Jacobs Bags as many types of styles, has also been sought after by many big Hollywood stars.

  • Mr. FIFY||

    Forget not must, Marc by Marc Davis designs generally-free self-designed handbag decks in many types of styles!

  • Marc Jacobs translated?||

    ROLLER CAPTION: IN 1970, THE BRITISH EMPIRE LAY IN RUINS, FOREIGN NATIONALS FREQUENTED THE STREETS - MANY OF THEM HUNGARIANS (NOT THE STREETS - THE FOREIGN NATIONALS). ANYWAY, MANY OF THESE HUNGARIANS WENT INTO TOBACCONIST'S SHOPS TO BUY CIGARETTES...

    Enter Hungarian gentleman with phrase book. He is looking for the right phrase.

    Hungarian: I will not buy this record, it is scratched.
    Tobacconist: Sorry?

    Hungarian: I will not buy this record, it is scratched.

    Tobacconist: No, no, no. This ... tobacconist's.

    Hungarian: Ah! I will not buy this tobacconist's, it is scratched.

    Tobacconist: No,no,no...tobacco...er, cigarettes?

    Hungarian: Yes, cigarettes. My hovercraft is full of eels.

    Tobacconist: What?

    Hungarian: (miming matches) My hovercraft is full of eels.

    Tobacconist: Matches, matches? (showing some)

    Hungarian: Yah, yah. (he takes cigarettes and matches and pulls out loose change; he consults his book) Er, do you want ... do you want to come back to my place, bouncy bouncy?

    Tobacconist: I don't think you're using that right.

    Hungarian: You great pouf.

    Tobacconist: That'll be six and six, please.

    Hungarian: If I said you had a beautiful body, would you hold it against me? I am no longer infected.

    Tobacconist: (miming that he wants to see the book; he takes the book) It costs six and six ...(mumbling as he searches) Costs six and six ... Here we are ... Yandelvayasna grldenwi stravenka.

    Hungarian hits him between the eyes. Policeman walking along the street suddenly stops and puts his hand to his ear. He starts running down the street, round corner and down another street, round yet another corner and down another street into the shop

    Policeman: What's going on here then?

    Hungarian: (opening book and pointing at tobacconist) You have beautiful thighs.

    Policeman: What?

    Tobacconist: He hit me.

    Hungarian: Drop your panties, Sir William, I cannot wait till lunchtime.

    Policeman: Right! (grabs him and drags him out)

    Hungariamn: My nipples explode with delight.

  • ارض تجاريه||

    thank you a lotsssssssssssssss

  • للبيع||

    thank you a lotsssssssssssssss

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