Do We Need the FDA?
Our very own Richard Epstein has a must-read column in the new Hoover Institution journal Defining Ideas. His article tells the remarkable story of how insulin was discovered and came to market in the 1920s. And guess what? The FDA does not take center stage in that tale, as it would today if a drug were to come to market. As a result, insulin was able to be synthesized and sold in about a year's time--unthinkable with the current regulatory regime.
Richard tells the story of insulin, writing:
Prior to the heroic work by Banting and Best [the scientists who discovered and synthesized insulin], the standard treatment for diabetes was a relentless form of slow starvation...Why make this grim choice?...Diabetic children who might live just a few years longer could find themselves the recipient of a far better cure.
One child who won that bet was Elizabeth Hughes...
Diagnosed with a serious case of diabetes in 1918 when she was eleven years old, Elizabeth endured 40 months of strict and unflagging adherence to the Allen diet until she was raised from the near dead in 1922, when she began to receive regular insulin shots that allowed her to live a normal life. She died, with her diabetes kept secret from the world, in 1981 at 73 years old.
If today’s regulatory rules were in place, Elizabeth would have died a horrific death before her sixteenth birthday. There are two truly impressive features about the discovery and commercialization of insulin: the speed of its discovery and the rapidity of its successful commercialization by Eli Lilly and Company.
Today, Richard notes,
The thought that the next insulin could move from successful synthesis to initial marketing in about a year’s time is a pipe dream. Today, before a drug is released for general use, there is an endless cycle of FDA reviews that can take years to complete.
Most doctors and scientists agree that the FDA slows down medical progress by 3-5 years. Meanwhile, people are dying:
It was, of course, just that frustration that led to the formation of the Abigail Alliance for Better Access to Developmental Drugs. In 2001, Frank Burroughs, who would later found the Abigail Alliance, could not secure the experimental use of Erbitux or Iressa in time for his cancer-stricken daughter Abigail, as advised by her team of oncologists at Johns Hopkins. The drugs did not come until she had already died.
The Abigail Alliance’s website notes that every drug for which it has sought approval in the past eight years is now on the market, which shows that the FDA’s risk aversion can kill thousands of people in the name of protecting them against "quack" treatment.
Richard's column begs the question of whether we need the FDA at all. Do we need some regulatory body of the government to oversee drugs that will come to market? Or can we leave that in the hands of the private sector? If we did, would companies actually emerge that test the various drugs that pharmaceuticals synthesize? Would pharmaceuticals hire them as consultants of sorts, on a drug-by-drug basis? If so, can those companies, whose task it is to test new drugs, be trusted to deliver good and honest results? Their payments, presumably, will be coming from the very pharmaceuticals to which they may have to deliver bad news--is there a conflict of interests there that, therefore, necessitates government intervention?
What do you think? What is the solution to the problem that the FDA slows down medical progress by years, leaving people to die as a result?
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Comments :
May '10
Re: Do We Need the FDA?
God bless Richard's purity of conviction, but doesn't the government here perform a valuable function in making it safe for the drug companies to actually bring drugs to market? I would argue that the example of insulin is of another era, both more fatalistic regarding lethal risks and less litigious. Today the risks associated with liability would be so great as to prevent the capital markets from ever funding the development of drugs in the first place. One need only consider the list of withdrawn drugs to appreciate that drug testing, for however long it takes, is still far from foolproof.
Jul '10
Re: Do We Need the FDA?
If Friedman says nix it, We nix it.
May '10
Re: Do We Need the FDA?
In an ideal world, the FDA would be one of a competing number of testing and certification authorities - some private, some public - and patients would be able to research drug safety and efficacy themselves.
But in the real world, where the citizens are treated like children to be protected by the father figure of the Federal government, and no risk to the children is ever acceptable, it's doubtful we'll ever be able to get rid of the FDA and the dozens of other regulatory agencies.
Re: Do We Need the FDA?
Trace, I see your point--but in theory, if there was no FDA, would private actors step in to fill the need to test drugs and ensure they are safe? Surely there would be a market need for this because without it, if pharmaceuticals brought bad drugs to the market, they would incur major costs in the form of lawsuits, bad publicity, etc.
Aug '10
Re: Do We Need the FDA?
Question: What was the impetus for the creation of the FDA? Was there some sort of "horrible drug run amok" incident that led congress to mandate that the government approve every drug?
If memory serves correctly, Upton Sinclair's "The Jungle" was a big part of the motivation behind the creation of the FDA, but that only really explains the "food" part of the acronym.
Any historians know how congress was convinced to add "drug" to the acronym?
I'm tempted to guess it was thalidomide, but that scandal didn't happen until many decades after the FDA already existed.
Aug '10
Re: Do We Need the FDA?
Emily Esfahani Smith, Ed.
Trace, I see your point--but in theory, if there was no FDA, would private actors step in to fill the need to test drugs and ensure they are safe? Surely there would be a market need for this because without it, if pharmaceuticals brought bad drugs to the market, they would incur major costs in the form of lawsuits, bad publicity, etc. · Jan 5 at 9:10am
Indeed, when it comes to product safety, Underwriters Laboratories has performed the same function quite nicely for over 116 years. One could argue that the FDA unfairly prevents UL from also taking advantage of the lucrative drug safety market.
Nov '10
Re: Do We Need the FDA?
Here's the Wikipedia history, fwiw.
Jun '10
Re: Do We Need the FDA?
Underwriters Labs immediately springs to mind when the question of privitizing the role of the FDA is discussed. The deaths caused by FDA over regulation aren't just in the drug category. Don't forget the wide range of medical devices and innovative therapies regulated into stagnation mode by the FDA. Often the regulation violations involve punctuation or such trivial nonsense that you are astounded by the FDA mindset.
May '10
Re: Do We Need the FDA?
Misthiocracy
Indeed, when it comes to product safety, Underwriters Laboratories has performed the same function quite nicely for over 116 years. One could argue that the FDA unfairly prevents UL from also taking advantage of the lucrative drug safety market. · Jan 5 at 9:34am
I think though the stakes are far higher here rendering private firms unequal to the task of quelling the nerves of investors. A material one injects or injests is less intuitively obvious than a consumer product. A private firm will not be able to hold a drug company harmless, nor will it offer any protection from lawsuits -- it will simply become another defendant. The government's role is unique and I fear the cost of capital in an all-private world would have the same chilling effect on bringing drugs to market as the lengthy FDA approval process.
Jun '10
Re: Do We Need the FDA?
Trace, how would an all-private world raise the cost of capital? I also don't see where the FDA imprimatur has offered any protection from lawsuits. If that were the case, lawyers like John Edwards would have had humdrum careers handling local real estate closings.
Aug '10
Re: Do We Need the FDA?
Without the FDA, the marketplace would find it's own regulatory metrics. You can't protect everybody from everything all the time. You can try and legislate safety but the costs will be rebuffed as too high. We are finding that out now.
Lawyers and the internet would probably provide all the warning and punitive measures.
If you knew how much psychics still make in this country, you'd realize that patent medicines and quackery will always be with us. The FDA has serious mission creep and it's stomping around the farm now, threatening a whole way of life. Compliance will be overly expensive and family farms will suffer.
It's a good time to measure the contribution versus the cost of most of these agencies.
Nov '10
Re: Do We Need the FDA?
John Stossel has spoken compellingly about this. There's ample reason to think that we'd be much better off without the FDA.
But we find ourselves in the unfortunate position of having to pick our battles. I think we need to spend our time on the lowest-hanging fruit - repealing Obamacare, blocking a wholesale takeover of American industry by the EPA, entitlement reform... we have a huge list of can't-wait priorities. I agree wholeheartedly that we should address the necessity of the FDA, but there's just so much to do first.
I know this is tangential to this discussion, but I think it's something that bears keeping in mind when we talk about our wish list of federal busybodies we'd like to put out of business.
Jun '10
Re: Do We Need the FDA?
Well, there are many tie-ins with Obama care & FDA regulatory excesses. Both give outrageous government power over medical, scientific, and agricultural experts. Both remove free choice from consumers. It might not be a bad idea to tackle them together.
May '10
Re: Do We Need the FDA?
Well the market is a wondrous and flexible thing so you may well be right, but my point is that the FDA is not only about increased cost and delays. The FDA is unique as a licensing body in being unsuable. So even if they mess up, provided there was no fraud involved on the part of the drug company, it means (I think) that there is a hard limit to the liability associated with an approved drug gone wrong. Aside from that, there are many people who (still) place great faith in the government as an arbiter is this situation and that reduces risk and costs in the market as well.
Jan '11
Re: Do We Need the FDA?
Perhaps somewhat off-topic; most Canadian kids could name Banting and Best as co-discoverers of insulin, but few would know that the Nobel was awarded to Banting and Macleod. Also, James Collip (from my alma mater) did the detailed lab work allowing a more pure form to be used quickly. The four of them shared the Nobel money. Perhaps also interestingly, Banting became a painter in his own right before his untimely death in 1941 just shy of 50 years of age.
Jun '10
Re: Do We Need the FDA?
"The FDA is unique as a licensing body in being unsuable."
So there is even less incentive for FDA regulators to practice common sense and realize their mission should be to assist manufacturers and food processing outfits to bring healthy drugs, devices, and food to consumers. As it stands now, they delight in setting up roadblocks simply because they can. They are like the IRS without the guns. Drunk on power.
Sep '10
Re: Do We Need the FDA?
Didn't the supreme court just rule that FDA-approved labeling does not shield drug companies from liability in certain cases? In these cases the FDA provides no commercial benefit to anyone over a private solution in the current tort environment.
Here's info on the case, Wyeth v. Levine:
http://en.wikipedia.org/wiki/Wyeth_v._Levine
Sage Milton was right, nix the FDA.