Alberto Mingardi  

Dan Klein on Scott Gottlieb

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Dan Klein comments on Donald Trump's FDA nominee for the Heartland Institute. Klein, with Alex Tabarrok, edits the FDA Review project of the Independent Institute.

On Gottlieb, Klein is very positive:

Scott Gottlieb is not a William Lloyd Garrison, but he motions consistently in the liberalization direction, toward reforms that would move the ball to the 45-yard line. Regarding the permission process, he has favored extending accelerated review to wider categories of drugs, simplifying permitting of generics, and depending more on surrogate-measure evidence, existing data, approval in other nations, and post-market follow-up. For patients, he has favored expanding "the right to try" or compassionate use. He has favored liberalizing manufacturer speech regarding off-label uses. He would, therefore, make the FDA less stingy with the permissions it issues. Also, he has favored making the FDA explain its decision when declining to permit a drug.

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CATEGORIES: Regulation




COMMENTS (14 to date)
Thaomas writes:

These all sound like what one would get if FDA followed cost benefit principles in in its operation. THAT is what we ought to seek, not "motion[ing] consistently in the liberalization direction."

Don Boudreaux writes:

Thaomas:

I agree with you that cost-benefit analyses are desirable.

In this light, the benefit of moving consistently in the libertarian direction is that, to the extent that this movement is successful, one result is that both the number and the reliability of cost-benefit analyses increases. In the absence of the FDA and its prohibitions, each individual - with or without the consultation of his or her physician (as he or she chooses) - would make a series of personal cost-benefit analysis, throughout time, regarding various medical options.

This decentralized process of cost-benefit analyses would be on-going. Every hour of every day, each of many individuals would be doing his or her own cost-benefit analysis. And because each of these cost-benefit analysts would, unlike those who conduct cost-benefit analysis on government programs, (1) have more of his or her own money on the line, and, more significantly, (2) have his or her own health at stake, the results of these countless cost-benefit analyses would be much more reliable than are the results of unavoidably only occasional and information-thin cost-benefit analyses conducted on the overall effects of FDA policies and other government actions.

So, yes, by all means let's have more - and more trustworthy - cost-benefit analysis. One of best means of achieving this happy result in matters of Americans' health care is to abolish the FDA. To support the retention of the FDA - to support the retention of this agency's current ability to prevent Americans from using whichever medical products they individually choose - is to oppose maximum possible cost-benefit analyses.

AlanG writes:

I spent almost my entire working career in the biopharma industry (and still do a little consulting). While FDA is not perfect (no agency, corporation, person, etc. are), they generally do a good job reviewing new drugs. The times where drug approvals seem to take forever are usually because the sponsor has less than robust data to support efficacy or there are thorny safety issues that have to be managed. FDA has to evaluate new drugs based on their risk/benefit profile. Large clinical trials of new vaccines destined to be administered to healthy children are required to really understand what risks might be present. Would you want this any other way?

I laugh when other national approval is mentioned as most important new drugs are approved in the US first (this comes from FDA's own data). FDA is constantly in discussion with the European Medicines Authority on important issues. IMO, this is just a false issue.

FDA already uses extensive post marketing follow up both for safety and efficacy and maintains a data base of the agreements with sponsors. Surrogate markers have consistently been used when the science supports it. How do you think all the HIV drugs were approved? They certainly did not have a mortality end point.

The whole compassionate use thing is complicated. I worked on the policy statement that PHS promulgated back in 1991 on expanded use of experimental HIV drug and that policy worked well as a stop gap until we had the newer class of protease inhibitors approved several years later. There are already sufficient mechanisms in place to allow companies to provide experimental drugs to patients. Companies can also recoup clinical development costs through the Treatment IND regulations (though I am unaware of any company that has done so). In most case, compassionate use is limited by the amount of clinical trial drug available as the company's priority is to complete the trials and file for regulatory approval. Then Novartis CEO, Daniel Vassella, instructed his manufacturing team to scale up production of Gleevec and provide it on a compassionate basis to all the leukemia patients who needed it once the confirmatory trial showed its life saving potential.

I could go on but will conclude by saying the fault often does not lie within the walls of FDA when drug development doesn't go as fast as one would like.

AlanG writes:

Don Boudreaux writes, " One of best means of achieving this happy result in matters of Americans' health care is to abolish the FDA. To support the retention of the FDA - to support the retention of this agency's current ability to prevent Americans from using whichever medical products they individually choose - is to oppose maximum possible cost-benefit analyses."

I fully understand that this blog has an intense libertarian bent. However, I conceptually don't understand statements such as this one. The FDA's role is to assure the safety, efficacy, and quality of the product it regulates. In the absence of such an agency who would be responsible for regulating the product's quality (contamination occurs and recalls are frequent). Who will do the facility inspections?

One of the key outcomes of the FDA review process is the drug label that provides the pertinent prescribing information relating to both safety and efficacy. this information is constantly updated post-approval as new uses are found for the drug or new safety issues arise.

For almost all drugs the full safety profile is not known until some years after the initial approval as safety issues constantly arise (many of the new issues relate to drug-drug interactions that cannot be studied during clinical trials). In the absence of an FDA who will study these issues and update labeling. You cannot make an informed decision in the absence of such information. In the absence of an FDA, will tort liability increase? Currently, pharma companies can use the 'FDA defense' in court and in most case prevail (look at how much money Merck has had to pay out because of all the rofecoxib lawsuits).

Would it surprise you to know that most practicing physicians have never read a drug label and that the pharmacology course they take in medical school is woefully lacking? Individual choice is great if you are expert enough in the field to make such a choice.

Don Boudreaux writes:

AlanG:

It is illegitimate to infer how physicians (or health-care markets generally) would operate in the absence of the FDA from the current actions of physicians (and health-care markets) with the FDA. People respond to incentives. Much of today's observed behavior and outcomes are artifacts, for better or worse, of FDA policies. These behaviors and outcomes will change if FDA policies change or are eliminated altogether.

As for who will regulate drug and medical-product quality absent the FDA the answer is market competition. You might believe that market competition is a poor substitute for the oversight and restrictions currently exercised by government bureaucrats (who spend other peoples money and are not directly responsible to the millions of strangers whose lives these bureaucrats affect with their policy decisions). That belief is understandable, although, I think, mistaken. But holding such a belief should not prevent you from being able to understand statements such as the one that I made in my previous post.

AlanG writes:

Don Boudreaux:

Market competition is the rote answer to everything, yet it can fail with devastating results. Let's take the example of a new vaccine that is given to health people. How does the market judge its safety, purity and potency (the FDA standard) in the absence of a regulatory authority. At the beginning of development there is ZERO data on all three. When should people be allowed access to this vaccine? Who and how should any testing be done prior to first in person administration? Should there be unlimited tort liability in the case of something going badly wrong (and the potential for that is great; liability is capped for childhood vaccines right now)? Who is going to monitor and record any adverse reaction to the vaccine? Is there a point in time that the vaccine should be totally withdrawn for the market? I have never seen good answers to these questions.

I have used the case of vaccines since they are perhaps the greatest public health advancement that we have seen (antibiotics being a close second). Risk is not tolerated with vaccines in the same manner as it is with pharmaceuticals. Even within pharmaceuticals risk is an independent variable depending on the condition being treated.

robc writes:

The answer on vaccines is I would allow them to be used on my child after Underwriters Laboratory* approved them.

How do jewish people know that their food supplier is following proper Kosher procedures? Independent (or actually, many independent) certification orgs do it in the absense of regulatory authority.

*or the drug equivalent, whatever that would be.

I also support ending occupational licensing, including medical licenses. But I bet my insurance company would still require in-network doctors to be AMA certified (or maybe not).

Jon Murphy writes:

AlanG:

How does the market judge its safety, purity and potency (the FDA standard) in the absence of a regulatory authority...

Oh, there are many many ways. Medical researchers can research the vaccine (incidentally there are these amazing things called "medical journals" where researchers can report and debate findings). The bigger way is simply by allowing people to choose their level of acceptable risk with consultation with their doctor (that is what they're there for, after all). For example, let's say there is a new vaccine for Alzhimer's. Various tests conclude that it has a 50% effectiveness, and a 0.01% chance of horrifying side effects. As someone who watched their grandfather die from Alzhimer's, I may prefer such a vaccine. Others (such as the FDA) may not. Why should their preferences take priority over mine?

Of course, these are just two ways the market could do the same function. There are surely many more than no one has thought of yet.

Remember what "the market" is: all a market is is an institution, just like the FDA. It can handle the same functions. It may even do them better. But what's fantastic about a market is the sheer number of brains it can bring to bear on a problem. Currently, in our globalized world, we have some 4 billion people in the wealthier parts of the world working together to bring the remaining 3 billion out of poverty (and doing a good job of it, too) through markets. Why not bring this same institution to medical research? Surely, as a consultant, you must know that the greater your "n", the closer you are to the true mean? So, then, why limit your "n"? Why limit your research only to the handful of people at the FDA when you could have literally billions of people working on the same problem?

On a more philosophical note, the FDA's restrictions have very strong harmful effects (as documented by Henderson, Tabarrok, and others). The FDA, by its very existence, may be working against its very mission; it may be endangering more lives that it saves. That alone could be reason enough to disband it.

The tl;dr version: there's no reason to assume the FDA's functions wouldn't exist absent the FDA.

AlanG writes:

Jon Murphy - you totally missed the point of the post. I was not discussing therapeutic vaccines but those that are given to healthy individuals. Such trials require enough patients to detect very rare adverse events. If you have a 1 in 10,000 adverse event (not unusual) the vaccine trial needs 30,000 patients. If you think this is going to be easy to do and the market will take care of things good luck.

there is a reason that we have the vaccine compensation law in the case of a rare AE. Absent this there would be no vaccines.

Mark Bahner writes:
Let's take the example of a new vaccine that is given to healthy people. How does the market judge its safety, purity and potency (the FDA standard) in the absence of a regulatory authority.

Why is regulatory authority needed to judge safety, purity and potency? Consumer Reports, Good Housekeeping, and Underwriters Laboratories have been judging products for years without regulatory authority.

Mark Bahner writes:
There is a reason that we have the vaccine compensation law in the case of a rare AE. Absent this there would be no vaccines.

How does that relate to whether or not the FDA should have a regulatory role, or merely an advisory role?

Ron W. writes:

Markets are good at rectifying problems once they occur. Is there evidence that they are good (enough) at preventing problems?

Jon Murphy writes:

@AlanG-

If you think this is going to be easy to do and the market will take care of things good luck.

I don't think it would be easy to do. That's why (among other reasons) I advocate a market-based approach

Martin writes:

Judging from this post under a free market system more people would die from unsafe drugs and fewer people would die from lack of access access to drugs. Despite people's revealed preferences as consumers I think they'd still be upset about the situation as voters, for much the same reasons the FDA currently overregulates. This might not make the free market approach impossible if people see really dramatic benefits, but I think there's a good chance that if we ever abolish the FDA we'll have it back before long.

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