FDA

Scott Gottlieb: Trump's Nominee for Food and Drug Administration Commissioner

Understands how over-regulation is slowing down innovation in medicines and foods

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ScottGottliebAEI
AEI

Products regulated by the Food and Drug Administration (FDA) account for about 20 cents of every dollar of annual spending by U.S. consumers, amounting to more than $2.4 trillion in annual consumption that includes medical products, food and tobacco. The agency regulates medicines, diagnostic tests, medical devices, food safety including those made from modern biotech crops and livestock, food labeling, and tobacco and nicotine products. What the agency's bureaucrats decide has signifcant impact on U.S. economic growth and the livelihoods of Americans.

President Donald Trump has nominated physician and American Enterprise Institute scholar Scott Gottlieb to become commissioner of the agency. Gottlieb earlier served as deputy commissioner during the Bush administration. Gottlieb has long been a critic of FDA's increasingly risk-averse culture that is slowing down the approval of new medicines. Defenders of the agency often cite data suggesting that the agency approves new medicines faster than other drug approval agencies abroad. That is true if only the period of time after a drug maker has submitted its New Drug Application (NDA) for approval is taken into account. More consequentially, increasing FDA requirements for longer and more extensive clinical trials before the NDA is submitted has substantially lengthened the periods and raised the costs of getting new treatments from petri dishes to patients' bedsides.

Consider that researchers at the Tufts University Center for the Study of Drug Development have estimated that in 1991 it cost $412 million (2013 dollars) to develop and obtain approval for a new pharmaceutical. Last year, they calculated that it now takes more than $2.5 billion, a six-fold increase.

Gottlieb, who has been associated with venture capital side of medical innovation, will seek to change the agency's culture from the current highly precautionary approach to one that more readily recognizes that benefits always come with risks. Under his direction, the agency would likely exercise a lighter regulatory hand over the development of new medical apps and diagnostics while seeking to work out the best way to speed up the approval of novel therapeutics based on stem cells and gene-edting technologies like CRISPR.

Gottlieb is keen to get generic drugs approved quickly in order to bring down prices for consumers. In an August 2016 op-ed in the Wall Street Journal, he noted it now takes more than 2 years for the agency to approve a generic drug application and that the costs had risen from $1 million in 2003 to over $15 million now. He added, "This means that a drug may not face brisk generic competition until it exceeds $25 million in annual revenue. Thanks to these changes, infrequently used generics—such as clomipramine for major depression—may now have only one competitor and cost as much as branded drugs." Gottlieb also cited research that estimated the FDA's proposed generic labeling rule would expose generic drug manufacturers, who supply 84 percent of all prescriptions, to failure-to-warn product liability lawsuits, costing more than $5 billion in 2017. That rule is supposed to be finalized in April. As commissioner, Gottlieb might be able to halt it.

While not a radical reformer, Gottlieb clearly has a good understanding of how over-regulation has been slowing down innovation in medicines and foods.

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  1. I can’t wait to smoke some candy flavored thalidomide cigarettes!

      1. The FBI has a special unit just to monitor your internet activity. Within the agency, it’s considered a punishment detail that is actually worse than getting fired.

        1. DOES THIS DRESS MAKE ME LOOK FAT?!?!?
          It has come to my attention that the FDA (a branch of Government Almighty; Praises Be!) wants to force you and your smart-phone apps developers to spent “about $31 million”, see http://www.post-gazette.com/pg…..d=news.xml , for each “medical” smart-phone application that is developed. At http://www.lexology.com/librar…..ab4965868e we can see that anything that? “Allows the user to input patient-specific information and, with the assistance of formulae or processing algorithms, produces a patient-specific result, diagnosis, or treatment recommendation.” ? WILL be regulated!!! So, knowing the history of the FDA, I can confidently predict, that, say, you or one of your apps developers that helps you sell smart phones, will, say, want to develop an app for those women who can’t or won’t trust their husbands and/or boyfriends, or even ANY of their multitudes of husbands and boyfriends, to honestly answer that perennially recurring, ancient old question, “DOES THIS DRESS MAKE ME LOOK FAT!?!?”

          1. So y’all devise a clever rational, mathematical, scientific analysis algorithm? Take that smart phone picture, run the program, and, wallah, like magic, THE Ancient Old Question is honestly answered! Woo-Hoo! ? But, the FDA (Praises Be!) will delay the sale or distribution of that app, by a decade or two, and inflate the price a hundred-fold? Because it is a MEDICAL APPLICATION that diagnoses obesity! Not that I am complaining; we Scienfoologists know VERY well, that Government Almighty LOVES the children, and we are ALL children, in the eyes of Government Almighty! Praises Be!

          2. Very nice. Unfortunately in the age of the sophisticated selfi it is increasing difficult to know what is really going on in the pictures people choose to share. Even well adjusted algorithms may err on the side of caution and do serious damage to already fragile egos. One also must consider the implications of such algorithms falling into the clutches of the evil AI we keep hearing about. Nevermind robopocolis, if everyone heard the truth 0 of the time civilization would come screeching to a halt.

            1. I thought I edited mot carefully 🙁
              *truth 100 percent of the time*

      1. Among many, many other things.

        1. It’s not the leprosy, it’s the syphilis that’s the worse problem. Both cause body parts to rot off but at least leprosy doesn’t cause the madness.

          1. SIV has a number of other chimeric diseases not yet described by science due to his… uh, behavioral tendencies.

            1. Are you trying to say that scientists don’t expect people to be fucking chickens?

              1. Chicks, chickens, they’re all the same to me! No turkeys, though… Gotta have SOME standards! And I have heard that turkeys can “gobble” uncontrollably, with their sharp beaks, at times… Could be painful, I’m a-tellin’ ya…

  2. The Republicans want us to drink unsafe water and food and want comoa ies to poison our cats.

    The Statists who want to make our food more expensive and who add lead to our water and then blame us told me so.

    1. Yeah but what do you know, you’ve been drinking lead contaminated water.

  3. When he kills the overreaching regulations on eCigarettes I’ll be on-board. Until then, color me unimpressed.

  4. Christ, what a not-completely-an-asshole.

  5. RE: Scott Gottlieb: Trump’s Nominee for Food and Drug Administration Commissioner
    Understands how over-regulation is slowing down innovation in medicines and foods

    “Products regulated by the Food and Drug Administration (FDA) account for about 20 cents of every dollar of annual spending by U.S. consumers, amounting to more than $2.4 trillion in annual consumption that includes medical products, food and tobacco.”

    Well, let’s face it.
    We all have too much money as it is.
    We should all be more than grateful to give money to the FDA and other needless and worthless bureaucracies and their over-paid and under worked employees.
    We should all be over-joyed our surplus capital goes to really stupid ideas and politicians.
    Otherwise, we’d would be spending money on needless things like rent, food and retirement plans.
    No in their right mind would want that.

  6. What’s the big deal? So everything costs 20% more than it “should”, it’s not like people aren’t shopping.

  7. This Gottlieb guy is on the wrong track as well. The Germans had the right idea for how to treat chemical/process patents in the 19th century.

    1. You can only patent the synthesizing/manufacturing PROCESS. THAT is the purely human innovation that does not result in a land monopoly. Patenting the chemical (or gene in the case of biologics) itself is an act of trying to have govt license a monopoly over nature.

    2. Patenting the process encourages the patentee to expand production, achieve scale quickly, synthesize as many different chemicals as they can through that process, and thus create a big chemical library that can be used to research different uses/efficacies of that chemical/biologic.

    3. Yes – there needs to be some form of coercive meta-regulation of how to direct that research so that issues unimportant to the producer (eg safety, efficacy) don’t create an externality. But honestly the scope of this can also be agreed on by both consumers and producers in the same way that we can agree on standardized units of weights and measures.

    4. Generics and patent cliffs are damn near irrelevant in this system. The process patentee is already self-motivated to achieve scale before their patent ends. If someone else can research a different synthesizing process for that chemical, then that should be rewarded not have one of their outputs taken away from them.

    1. “1. You can only patent the synthesizing/manufacturing PROCESS. ”

      And *poof!* goes pharma R&D forever.

      1. You mean things like Oxycontin? (invented 100 years ago – by a German chemical company). Or do you mean things like expensive as all hell pharmas that are only expensive because our patent rules destroy the value of scale manufacturing? Or do you mean ‘research’ that is solely directed at extending patent protection for an identical chemical/biologic for a different use?

        Like it or not, the biggest drug companies now are mostly European or Japanese. The research itself is mostly done in Europe – as is the manufacturing/process innovation. We’ve already lost innovation that we may have once had – and I’d argue that we were never that innovative anyway (our chemical industry was always based on cheap oil inputs not innovation – and our pharma got a massive leap from the 20th cent German decision (unrelated to patent rules) to self-destruct). It was NOT because of FDA ‘overregulation’ – but because our patent system itself destroys actual innovation in favor of land monopoly rent-seeking. And even if we want to enhance the cronyism – WTF are we gonna enhance the cronyism for mostly foreign companies??

        1. I mean things like the drug that literally saved my life 3 years ago and that would not have been worth billions of dollars to develop without a patent over the chemical.

          So fuck off.

          1. Honestly this comment is nothing but highly generalized fearmongering that can’t be discussed or falsified or questioned. Only emoted. Maybe the only FDA reform we need is a commissioner who knows how to ululate.

            I’m happy for you but what’s your point?

            1. What’s yours? You spouted some nonsense about how our patent system discourages scale up while offering zero evidence or rationale. It doesn’t. And somehow you believe that only processes are worthy of protection and not the article itself which is just further nonsense. The configuration of a new device/compound is usually just as important than how it was made, if bot more so.

            2. Just one counterexample – penicillin is one of the most significant life-saving drugs of all time. Its history tells you that you don’t need a patent on the product itself. A patent on the product itself can stifle production of it. It is only really ‘worth billions’ and can save lives only when it CAN be synthesized/produced.

              Alexander Fleming (and Drs Florey and Heatley at Oxford later in early years of WW2) CHOSE not to patent it. In Britain – like the US then – he could have. Had it been patented then, no one else would have bothered. Exploitation of that would have solely been up to him. Since it wasn’t patented, labs did experiment with how to produce it. Within a year and a half, they succeeded in ramping up large-scale production via two different processes (both of which got patents but only for the process).

              Fleming himself has his famous quote about why he chose not to – I did not invent penicillin. Nature did that. I only discovered it by accident. The best drug discovery – entirely within the British/US model – and the researcher cites the German model and it works because the German model was used even though we were at war with them.

              1. BTW – Drs Florey and Heatley are mentioned because they ran the first clinical trials of penicillin on humans – but their production process was purely artisanal. They knew they couldn’t scale their process up and WW2 had just started. They too could have patented – and chose to save lives instead.

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