My own FDA

I think it’s important to prepare for the time when taxes go down and we finally get the government off our backs. In preparation, I’m creating my own FDA, because a bunch of bureaucrats shouldn’t be in charge of regulating my food and drugs.

If you want, you can subscribe. Not sure how I’ll run the subscription service – probably, you’ll just have to eat the exact same stuff I eat, and you’ll pay me a commission. The free market will determine the rate: no governmental price-fixing here. I’ll have tasters, just like the kings of England and France in the good old days. Real people, not faceless overpaid government workers, will either survive or fail to survive as they sample my meal to insure that it is fresh and not poisonous. The free market will determine their wages, and there will be no worry about unions (the membership of any potential Tasters’ Union would be constantly subject to attrition, so we will never have to worry about them trying to tell us whom to vote for).

As far as drug testing goes, I had originally thought it might be best to team up with a bunch of friends, kind of figure out together which drugs might be safe and which wouldn’t, but then I remembered that that would be Communism, so onto Plan B: I’m just going to trust all the drug companies. After all, why would they put out drugs that didn’t do what they said they would do? That would be bad for business, and only a moron would think that a company would act against its own interests. Anyway, right now the pharmaceutical companies are getting killed by all the heavy government regulation, and with that gone, they’ll be in a position to make much better drugs. All the extra profit from that will result in their hiring lots of extra workers to make those drugs, so the economy will perk right up. Then we can buy more safe drugs, and we’ll have finally broken the cycle of defeatism as we are wrapped in the embrace of the invisible hand of the free market.

You can see that there are easy solutions to the so-called “problems” of deregulation. Stay tuned for future blog posts investigating how I will be managing my life in the near future:

1. My own FAA (hint: why would airlines fly unsafe planes? BAD FOR BUSINESS!)

2. My own highway system (hint: I’ll be selling an EZ-Pass type device so that you can pay tolls on my highways quickly and easily)

3. My own Congress (hint: why pay government workers to run the country? I’ll be supplying guaranteed private workers to do the work far more efficiently)

4. My own army (hint: I’m considering the name The Grabois Boys for our battalion, and we are DEFINITELY ready to fight for you, provided we can negotiate a contract on the open market)

5. My own IRS (just kidding! Nobody is going to be paying any taxes)

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9 Responses to My own FDA

  1. As they say in Peru, Ja Ja Ja (ha ha ha). Sometime let’s have a serious conversation about how dysfunctional FDA is. Even a libertarian like me doesn’t advocate getting rid of it (though I do like the idea of just trying drugs out on your liberal buddies – if it works, we have a life saving drug. if it doesn’t, one less liberal. c’mon, just kidding!). but, it is a mess over there. as you know, i sit on the board of numerous tiny little biotech and medical device companies who have zero profits and will never have a profit. they are spending equity capital trying to improve medince (and make their venture capitalists rich, which i’m sure we’ll both agree is a noble cause). here’s one tiny little example. starting about a year ago, FDA began requiring biocompatibility testing on all devices (whether implantable, like a defibrillator, or not, like a tool used during surgery) that contain metal, including a metal called nitinol. nitinol has been used in literally millions of medical device implants for decades and never had a biocompatibility problem. but, it is a metal so FDA now requires a whole separate series of biocompatibility tests to show that it’s biocompatible before they’ll approve the device. ok, so what does that mean? of course it means that the company has to spend money doing the testing. and time? it’s a drag on economic growth and it delays getting life saving technology to patients. if this were a new, untested metal, i wouldn’t bitch. but, there is zero debate anywhere that nitinol is safe for implantation. interestingly, the other thing this means is the company has to sacrifice about 2 dozen rabbits (rabbits, it turns out, have an immune system pretty similar to ours so if a material is biocompatible in rabbits, it usually is also in humans). so, all your liberal friends at peta who decry animal testing and picket in front of medical device companies should go picket in front of FDA’s office in Silver Spring, MD. it is they that mandated the killing of 24 more rabbits to no useful end whatsoever. so, as they say, there are always two sides to the story. and, i think you’ll find that most guys like me are not in favor or completely abolishing the entire regulatory framework. i would even begrudgingly acknowledge that EPA has played a valuable and important role in making our water and air safe to drink and breathe. but, it has now run completely amok and is enacting through regulatory fiat things that could never and will never pass congress b/c the elected officials would get thrown out by the voters for legislating such nonsense. it is a reasonable balance we want, not abolition. that said, i would be completely comfortable with you talking my next USAir shuttle flight into Laguardia (oh wait, you don’t live in NY anymore).

  2. dangrabois says:

    The following would be REALLY stupid: a famous chef is working on developing a new restaurant that serves soup. Of course, all his soups begin with water, and the FDA gets involved, forcing the chef to perform tests to make sure that water is a safe food to eat as part of soup.

    The following would be REALLY smart: a famous chef is working on a new soup restaurant. He decides that deuterium (otherwise known as “heavy water”) would be a much better base than regular H20 for his soups. The FDA shuts him down immediately.

    The question then becomes: is the case of nitinol more like the first or more like the second? I’m guessing it is somewhere in the middle. Are there different forms of nitinol? Is the government forcing companies to repeat the same exact tests over and over? I don’t know where the truth lies. If the the FDA bigwigs are forcing needless and repetitive studies, they should be removed from their positions. When I have my heart attack, however, I want to make damn sure the material in my stent has been thoroughly tested (on as many rabbits as it takes). If the new product has an extra carbon atom in the chain, or extra molybdenum, or a different cesium isotope, I don’t want to be the guinea pig.

    I don’t believe in my heart of hearts that the FDA is trying to shut down development of new products. I do believe in my heart of hearts that the FDA is full of morons, since just about every company, agency, orchestra, foundation, or university has plenty of morons. However, it is wise, even from the libertarian point of view, for the FDA to err on the side of caution, because, if a material they approve turns out to be unsafe, the cost, both in dollars and in human life, can be tremendous.

    Bruce, you have posted on your blog (or maybe it was in a comment in mine, I can’t remember) that no administration has been as hostile to innovation as the Obama crowd. I think this is disingenuous. I am prepared to admit that Obama has been a disaster (though you and I will disagree on the reasons), but you can’t really think he wants to discourage innovation. You are in the business of funding start-ups, and of course any regulation is going to cost you money, but it would be naive of you to think that companies are just going to produce happy, safe, perfectly working new products just because we want them to (see Shield, Dalcon). And if someone’s going to stick a metal part in me, I hope it is tested til the cows home before my operation. In fact, test it on the cows before they come home.

    As for legislating by regulatory fiat, you’ve got to be kidding! Congress can’t pass a single law, especially if it is proposed by Obama. How else are we going to regulate anything at all???

    Perhaps we should test Michelle Bachmann on rabbits, see how they react…

    • Dan – the nitinol case is about as close to your first chef case as you can get. It is NOT the case that someone suddenly changed the composition of nitinol. This is a totally random act of stupidity across the entire agency. I have spoken to numerous companies about this and nobody has a rational explanation. For Margaret Hamburg (head of FDA) to make a public statement that FDA is encouraging innovation is the most preposterous statement I have ever heard (read the letters to the ed of the NYT by several prominent VCs if you don’t believe me).

      As to your point that companies won’t do the right thing if just left to their own – you are wrong. Believe it or not, the people who run companies (I sit on the board of numerous medical device and drug companies) really want to do the right things for patients. My companies have had numerous opportunities to cut corners and we never do. OK, that may in part be due to the regulatory ramifications of doing the wrong thing, but I’ve already acknowledged this some logical regulation makes sense. But, mostly, we do the right thing b/c we are honest and ethical people who would not sleep well at night if we did the wrong things for patients. There are bad actors in every industry or walk of life, but you don’t set up the entire regulatory schema to address the 1% bad actors. THat’s dopey.

      BTW, you commented that you would want to make sure that a new metal (or something else) had been thoroughly tested before it’s used in you. If it’s a new stent, that makes sense b/c there are already a bunch of approved stents that work just fine. But, what if you had pancreatic cancer (nearly always lethal and quickly) and there was a drug that had been tested in a few smaller trials and shown some promise (but far from fully vetted). Might you feel differently about getting that drug sooner? I bet you would.

      Finally – on Obama and innovation. I stand firmly by my commentary. I think this president is living out the 60s socialist dream in the post-Soviet era. He’s smart enough to know that the 60s era vision of communism turned into nothing more than fascism by another name, but has a new vision where government runs our lives and private enterprise goes away. Nearly every major policy move he has made (Obamacare, Dodd-Frank, tax policy) has been very anti-innovation. Show me a culture where entrepreneurship and innovation thrives when the government is picking winners and losers and industries to support and I’ll buy you an andouille sausage dinner.

      • Sorry – forgot to reply to your final point about regulatory fiat being the only way to get stuff done b/c congress can’t pass a law. I suppose I could simply cite the constitution of the United States as an important document and the 3-branch system as one worthy of preserving over time, independent of which party controls, and stop there. But, you know me, I can never “stop there.”

        C’mon, Dan!! When Obama took office in 2008, he held big majorities in both houses of congress (257-178 in the HR and 59-41 in the S). Even after the drubbing in 2010, he holds a majority in the S (53-46) while having a 242-193 minority in the HR. So with full control over the legislature and presidency for 2 years, he couldn’t “get anything passed” and you’re blaming that on who? Could it possibly be that he just has really bad ideas and the country has an immune system against bad ideas. The only way to pass that nightmare of a healthcare bill was to ram it through using an obscure procedural trick vs. having it fully vetted as the constitution envisioned.

        Now, contrast this situation to 1980. Reagan was swept into office after 4 years of Obama’s mentor, but found himself in exactly the situation Obama is in now. He did not enjoy 2 years with control of both houses of congress. The dems still held the house (243-192, almost identical to today’s rep majority) and the reps had a majority in the Senate (53-46, also identical to today). And, yet, Reagan was able to get major legislative victories to right a sinking ship because he had good ideas that worked. Obama has put forth a series of horrible ideas that have rightly died and the ones he got through did more damage to our sick economy. So, the moral of the story is that a president with good ideas will get them done legislatively, regardless of where the majorities lie and bad ideas will always struggle to get done. Sounds like a system that is working pretty well. Circumventing it with unelected bureaucrats legislating through the Federal Register seems like a very risky precedent to me!

  3. dangrabois says:

    So much to answer! I’ll go in order.

    You make a claim with which I strongly take issue: “There are bad actors in every industry or walk of life, but you don’t set up the entire regulatory schema to address the 1% bad actors. That’s dopey.” I totally disagree. On the most basic level, we have regulatory agencies exactly because of that 1%. If we had 10% bad actors in industry, there would be no industry. If we had 0%, we wouldn’t need regulation. Somewhere in the middle, we need regulation, and that’s where we are. Also, not everything is known about a product when it is released. I know there are times when I have composed a letter and thought it great, only to have an outsider proof-read it and find a glaring mistake. Regulation protects consumers. It costs us (and you!) money, and is worth it.

    If someone is an idiot and insists on repetitive testing of a product that has been proven safe over and over, then that person is not qualified to do her job. I have not heard back from the current head of the FDA, so I can’t properly adjudicate this debate (and I know nothing about nitinol), but I’m siding with you in saying that an incompetent administrator should be removed. On the other hand, I’ve been to doctors whom I deemed less than ideal, but that does not make me condemn all of modern medicine.

    I believe there ARE provisions for experimental drugs to be administered to terminal patients, so we can’t pretend that never happens. I would like to see more of this.

    As for Obama, I’ll go back to a medical analogy. You break your arm. You go to the hospital. The insurance company will only ok a band-aid, rather than a cast. Your arm does not heal, and you blame the doctor. In the case I am thinking of, Obama did the smart thing to try to pump money into the economy, but he was stymied at every turn and was able to push through only a lack-luster stimulus package that probably fended off disaster, but not much better. Now he is being blamed for a poor economy. There is much that is wrong here, and likely not enough time to pick it apart (we can try!), but let’s look at a few things:

    1. Obama is proving to be a highly unpersuasive president and a class-C politician. In the case of the stimulus, and of Obama-care, he had majorities of Americans supporting his position, but did not bother taking his case to them. Instead, he (tepidly) tried to persuade Congress to go his way. Bear in mind that the Senate does not work as a mirror of public opinion. You rightly point out that the Dems have 53 senators, but the Reps have used the Senate rules to ensure that only a 60 vote majority can pass legislation. Each Senator has tremendous power. I’m not arguing in favor of another system, just pointing out that government is run in certain ways. I’m not arguing that the Reps did anything illegal. I would parse it this way: Obama is highly unpersuasive. The Republican party has mastered the art of persuasion. They have convinced a majority of Americans that health care for all is a bad idea (I remember Reagan doing the same) and that shoveling money into the hands of the rich is a good idea. We Dems all thought that Obama would be eloquent and true enough to make the opposite case, and he has proved to be a grave disappointment. Reagan, by contrast, was an incredibly acute and talented politician, and was able to overcome an opposing Congress to get what he wanted.

    Your Tea Party friends have essentially said that they will oppose ANY legislation Obama proposes in order to defeat him in 2012. This I find evil. To be willing to do ill to the country (“don’t raise the debt limit!”) for political gain is morally wrong.

  4. I ain’t buying what you’re selling, cuz. First, I wish we could blame each and every dysfunctional action at FDA on one rogue bureaucrat, but if that’s the case then the place is filled with rogue bureaucrats and we need to fire all of them (if, in fact, it were possible to fire a gov’t employee for incompetence; more likely, they get promoted so the next boss can deal with it). The entire place is dysfunctional and the fish stinks at the head.

    You are correct that FDA has what are called “compassionate use exemptions.” But, they can only be used sparingly and most companies don’t use them b/c the risk of FDA coming back at you later are too high.

    As to your contention that Obama’s failures are a failure to communicate, I just have to laugh. For 2.5 years, he’s hailed as the great orator. We all hang on our seats for the next great speech. But, now that he’s failed miserably in the policy environment, the tune changes to “he can’t communicate his message.” I really think you need to step back and ask the tough question, “are his policies just totally out of step with the country?” I know you agree with them and I respect that (while disagreeing). But, the reality is that America is a very center/right country. Obama has governed from the ultra-far left. That’s about 15% of the country (you’re in the 15% – all good). Your statement that the country supported his healthcare bill is categorically incorrect. It was supported by well under 50%, rammed through anyway. It’s even less popular today than it was when passed. Many republicans won in 2010 mid-terms by pledging to unravel it. It’s bad policy and the American public knows that.

    The claim that the stimulus was the right solution, but not enough has become the last gasp of this administration. It’s not bad politics b/c, of course, it’s impossible to prove a negative. However, all these silly stimulus things (cash for clunkers, temporary mortgage breaks, etc.) have failed to do anything. I think all serious economists agree that the only way out of our current economic mess is GDP growth. If you can point to a time in the history of any country where Keynsianism has worked, I’ll sign up. Doesn’t exist. You can’t spend your way to prosperity. You have to grow your way there. Interestingly, in modern times, it was a democrat (JFK) who led the way on that policy approach. Even Obama now admits that there’s no such thing as “shovel ready.” We have to go back to the pro-growth policies started by Reagan (continued by Clinton) that have made our economy strong. I guarantee you the tagline on Obama’s 1-term presidency will be “he made it worse.”

  5. dangrabois says:

    We’ll take the FDA first. If the FDA is filled with corrupt bureaucrats, as you say, then I guess you would propose one of three options: either taking my sarcastic suggestion that we each just deal with our own food and drug safety; hire a private company to do our food and drug testing; or fire everyone in the FDA and start again. As far as I can see, keeping the FDA in place but attempting reform is the very worst solution – except for all the others.

    For “compassionate use exceptions,” you already know how I feel. Perhaps Obama should propose expanding them, but I would bet pretty soon the right would come back saying he’s trying to kill innocent Americans with untested drugs. But at least you and I can agree that it would be a good thing to try to pass.

    I’m not sure if Obama is failing to communicate his message, or if he has no message. He was a wonderful speaker during the campaign, but he seems to have lost his mojo. When he decided not to raise taxes on billionaires, I lost all respect for him. He appears to have only one goal, which is to appeal to the 17 voters who remain undecided until the bitter end. I disagree strongly that he has governed from the far left. He left Bush’s tax cuts in place. He practically gave up on healthcare, making huge concessions to the right. You guys should be quite pleased to have him as president, since he grants your every wish.

    The healthcare bill had tremendous support until the right started talking about death panels. Indeed, I am guessing that healthcare was the issue that got Obama elected in the first place – people actually liked what he was saying. You state that the US is a center/right country, but you can’t possibly disagree with me on one fact: Obama was elected. There must have been something in his campaign that made him attractive to Americans. What did he talk about? Healthcare for all. Fairness for the middle class. Sharing the burden equally. My criticism is that he gave up on all his issues. People can’t afford health insurance now, especially since they are losing their jobs.

    You know that I am no economist. I do read Paul Krugman every week, and I’m sure you hate him. He thinks the stimulus was way too small. Yesterday I was listening to the radio, and Joseph Stiglitz was saying the same thing. Others disagree. You can’t make the point that no serious economist agrees with the left on this point unless you define a serious economist as one who agrees with you. Let’s admit that there are different points of view out there. The point of stimulus, as I understand it, IS to stimulate GDP growth. Businesses now have piles of money, and they aren’t spending it. Giving them more money won’t help. Give my my $.60 allowance (going back to the ’70’s here) and I might buy a candy bar. Money needs to flow freely. It can’t flow freely from me to you if I don’t have any.

    By the way, tax rates were higher under your man Reagan than they are now. My question for conservatives is this (and perhaps you’ll answer it): if taxes are too high now on the wealthy, where should they be? Is it fair that Bill Gates and I should pay the same dollar amount in taxes, since we are both US citizens? Is there a such thing as taxes that are too low? Should there be no taxes? Negative taxes? Should we reverse the tax brackets so that the less you make, the higher your percentage? That would seem the inevitable conclusion of the notion that you have to put money in the hands of those that can create more wealth.

    • I stand by my comment that we are a center/right country. If you look at who traditionally gets elected and what they sell to get elected, that’s hard to argue. But, I agree with you that the 2008 election was an odd anomaly. Obama definitely ran as a 60s era anti-American socialist. It was clear to anyone who was listening to what he said or spent anytime scrutinizing his relationships with people like Jeremiah Wright or Bill Ayers. But, the country was so desperate to (a) get someone other than George W. Bush (or anyone associated with his party) and (b) believe that we could have our first black president without having a socialist, they buried their heads in the sand and voted for him on some vague promise of hope and change. I have tons of centrist friends (I think we’d have to concede that neither of us are centrists) who voted for Obama and are now shocked at the way he’s governed with hyper regulation, government takeover of industries, incessant anti-business rhetoric, apologetic anti-American foreign policy, etc. In other words, they are shocked and disappointed that he’s a 60s era anti-American socialist. I point them to the stuff he said on the campaign trail and say, “OK, why are you surprised?” They typically just hang their head and say, “yeah, I guess I should have seen it.” In their defense, there was the constant drum of the liberal media supporting Obama in the campaign.

      I think you are taking a major rewrite on history to say the healthcare bill was popular until people started talking about death panels. Government takeover of healthcare has never been and will never be popular in America. There was and is wide support for fixing some of the problems with our system, but Obama’s throw the baby out with the bath water approach has always been very unpopular.

  6. Dan Grabois says:

    This is a fascinating discussion (hopefully our hordes of readers agree). I’ll go in order, as usual:

    I’m not sure what you mean by “a 60s era anti-American socialist,” which is how you say Obama ran. I’m getting nervous that you mean that anyone who opposes American policies is anti-American. That is a dangerous piece of rhetoric, in my opinion. As you know, the country was founded on the right to oppose the government, and we have had several uncomfortable periods where this was forgotten, to our detriment. In the late 60s and early 70s, many people opposed the Vietnam War, and viewing them as anti-American socialists because of their opposition would have all kinds of implications for how we treat speech in this country that I don’t even want to think about, so I’m going to assume that’s not what you mean and instead try to figure out what you do mean.

    My guess is that you are talking about the belief that government programs, rather than “free market solutions,” will dig us out of any problems we encounter. I think you have a strong belief that government always, or almost always (you concede the need for the FDA in principle), makes things worse and that business will flourish in the absence of government. It seems that you have the idea that Obama would like to do away with business, such that the government grows and sells our food, operates our stores, cuts our hair, removes our gall-bladders when necessary, plays our music, paints our murals, and provides veterinary care for our animals. OK, I’m exaggerating, but you get the idea, and Obama has never even dipped his little toe into this territory, nor do I wish he had. Indeed, a big part of his campaign was funding development of new sources of energy … through business.

    Now, if what you mean by “socialism” is that the government helps people in need, that’s a different story – then you are giving a tainted name to something that many Americans believe in. A good example here would be social security. Before the bill was passed by Johnson, Republicans tried to derail it, saying it would be the end of us. I think most Republicans now would not approve of dismantling it.

    A good example of how easy it is to draw different inferences about American beliefs comes out of this. Here’s a thought experiment. Poll an imaginary 1100 random Americans, and ask them the following: “How do you feel about a government program which compels middle class workers to contribute money to a government-run retirement plan, much of which is then redistributed to the poor?” I think there are, indeed, many in our random sample who, reacting especially to that key word “redistributing,” would say “No thanks.” Ask the same people, instead, “How do you feel about Social Security?” and you’ll get the same answer you got from the Tea Party earlier this year: “Keep the government’s hands off my Social Security.”

    This is my criticism of Obama’s administration, and I am sorry if you are irritated that people who once touted his communication skills are now lambasting his failure to communicate. He ran an incredible campaign, and was a brilliant speaker on the trail. If Obama is reelected, it will be because of that same campaigning ability (I know: over your dead body). But as soon as he got into office, he seemed to whither on the vine. One example, and one you have disputed, is health insurance for all. You say this: “There was and is wide support for fixing some of the problems with our system, but Obama’s throw the baby out with the bath water approach has always been very unpopular.” Again, many polls DID show a majority of Americans (at least in the early days of the Obama presidency) wanting a national health plan. These were definitely not the polls that asked, “Do you favor a government takeover of healthcare, in which faceless bureaucrats decide your fate based merely on a data set piped into their computer?” Instead, they were most likely polls that said, “Do you favor a system in which all Americans receive health insurance, in which 40,000,000 uninsured Americans no longer crowd our emergency rooms, in which even a middle class working person is entitled to the same care that Warren Buffett, Bill Gates, and American senators receive?” Then, you get a big fat YES. Why Obama never took this to the people who elected him BAFFLES me.

    Before you take me to task on this post, one of my questions from before has gone unanswered: How low should taxes be, especially for the wealthy?

    And, to answer your earlier question, an example I would offer for how economic stimulation lifted a sagging economy would be WW2, putting an end to the disastrous economy of the Depression.

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