REGULATORY AFFAIRS PROFESSIONALS SOCIETYBy Zachary Brennan31 January 2017In a sign of what’s to come for the US Food and Drug Administration [FDA], President Donald Trump told pharmaceutical company CEOs Tuesday that his administration will be “cutting regulations at a level no one has ever seen before.” The comments, which came before the meeting with CEOs from industry group PhRMA, Merck, Novartis, Johnson & Johnson, Celgene and others, Trump said in terms of the drug approval process: “We’re also going to be streamlining the process, so that from your standpoint, when you have a drug you can actually get it approved, instead of waiting for many, many years."
He also called for significantly lower drug prices and again for better negotiations on drug prices between Medicare and companies. “We’re going to get the approval process much faster,” he repeated, noting that “one thing that’s always disturbed me is that you come up with a new drug for a patient that’s terminal and FDA says you can’t have this drug used on this patient and patient will be dead… we don’t know if drug works or doesn’t work, but the patient’s not going to live for more than 4 weeks.”
The comments on terminal patients seemed to be a reference to what FDA calls compassionate use or expanded access, and as FDA has sped up that process, experts have noted that the difficulty for many of these terminal patients, who have either run out of treatment options or didn’t have any to begin with, is not getting FDA to sign-off on the use of an investigational drug [FDA approves more than 99% of all expanded access requests it receives] but in getting the companies running the clinical trials to allow new patients to enter trials.
FDA Cuts
“Instead of it being 9,000 pages, it’ll be 100 pages,” Trump said, perhaps in reference to FDA’s rulemakings, guidance and other regulations. He also offered a one-liner about companies not getting their products or their manufacturing plants approved in the US that drew laughter from the group. Between 75% and 80% of all FDA regulations will be eliminated, he added, before commenting on a lack of foreign regulations without any specifics. “It’s very unfair what other countries are doing to us, a lot of that has to do with regulation,” Trump said. “Other countries have no regulation and you go there for that reason.”
But as others have noted, no matter where a drug is manufactured, companies have to follow US laws and regulations in order for that drug to enter the US market, which is still the biggest market for pharmaceuticals in the world. As far as his choice for FDA commissioner, Trump said an announcement is coming soon. PhRMA CEO Stephen Ubl called the meeting positive and productive and said Trump’s agenda on taxes, trade and regulation could create 350,000 US jobs over 10 years for the biopharmaceutical industry.
Excellent. Dereg is how we were able to develop AIDS drugs so quickly. It’s ridiculous that CMS has to put up with monopoly pricing by pharma.
And how many regulations are created in order to protect people from unsafe medicines? Remove the regulations, and how much of the checks and balances that ensure safety will be removed as well? And if the new medications kill people (think of Vioxx) how will consumers of these pills be able to sue? The manufacturers will not be violating regulations, because most of them will be ripped up.
Second, how much trust can we put in an industry that has paid over 20 billion dollars in fines to the US Department of Justice for lying to doctors, committing fraud, and bribing people? No other industry has such a record of wide-spread fraud in the US. How will they act in a severely deregulated environment?
How many people are killed by regulations? Answers are always easy if you only look at one side of the equation. Regulation itself is very much like a drug in its own right…one or two intended effects, fifty side effects. American medicine is the most overregulated sector of the economy. And I might add that it’s not very effective as you pointed out in that Vioxx example. Milton Friedman calls this problem that of invisible harm.
http://www.downsizedcfoundation.org/fda.html
The left (not liberals, the statist left) has this fantasy of government as a caring, intelligent mother, when the actual behavior of government is an incompetent or abusive stepfather. FDAs banning of 23andme was the act of an ignorant power-mad doofus, not a concerned overseer.
As Dr. Carroll pointed out the Soviet Union’s history of drug development is pathetic.
Sclerotic mold fig bureaucracies do not protect you and do not lead to innovation. Drug companies are greedy. So what? They’ve also made amazing products that make our lives better and longer. Arguing specific examples of industry abuse does not take away from the big picture of net benefit to society.
A corporation is a person, in legal terms. It can buy and sell property, be sued, launch lawsuits, just like a legal person.
But what sort of person is a corporation? What are the personality characteristics, the patterns of behavior, the values, that make up a person? Dr. Joel Bakan at UBC asked this question, and wrote a book and made a film “The Corporation”. His conclusion was that corporations are driven by short-term gain, have no inherent moral code, and are driven only by self-interest. In short, they are psychopaths. Read the book / watch the film to see if you agree.
A major theme of this website is how the drug companies conceal critically important information about their products, leading either to harm to consumers by concealing side-effects, or useless interventions in the name of profit. What does that say about the nature of drug corporations? Are they going to behave more ethically in an environment of far less oversight? Isn’t past behavior the best predictor of future behavior?
And in terms of the drug companies and amazing products, many of the innovations occur in the universities or hospitals (insulin, penicillin). The drug companies are very good at commercializing and distributing an innovation.
Corporations are amoral, not immoral, as least as their duties are defined in their prospectuses. That is they are indifferent to the issue of morality and seek a profit. This may not sound attractive to a lot of people, but I care about results, not intentions, and the controlled economies have a miserable record.
Government agencies claim to be moral, but in practice often act amorally or immorally. The idea that we are going to appoint wise sages in white robes to protect the public free from the influence of K street corruption is fantasy.
So here in this board Martin Shkreli is demonized but not the bureaucrats who gave him power to exploit a monopoly pricing situation. Along comes Trump who says he wants to control monopoly drug pricing and regulation that freed Martin Shkreli from competition, and somehow he is a demon too.
I don’t get it. If the Shrkelis of the world bother you as they should, Trump should be praised for these approaches unless he doesn’t follow through, regardless of what one thinks of the rest of his agenda.
I wish we could escape from the cultural artifice surrounding the process of rule making and rule changing. It’s really just high-level monkey-work that few people have the patience for; I have no idea how it acquired all this bizarre moral and philosophical baggage.
Or maybe I do, and I just don’t like it.
It seems to me that the economics, in general, and the Chicago School of Economics in particular, is simply a religion that believes it’s a science. At its core is the fantasy that markets will eventually imitate natural evolution, that they will follow some kind of logic or order, but that’s never actually happened. Business deserves no more insulation from the rule of law than any other human endeavor.
What I particularly do not understand is the fetish for making a distinction between the public and private sector– as if regulations imposed by businesses are somehow inherently worse than regulations imposed by government. Obama’s EMR mandate was obviously a disaster, but we can’t let Epic and AllScripts off the hook. They are the ones who should bear final responsibility for their products– and the EMR really represents just a byzantine and capricious system of rules that must be followed. (The storage and retrieval capabilities are mostly irrelevant, which is why most of us in private practice prefer to use locked file cabinets or secure spreadsheets or whatever makeshift tools we build ourselves.) These software developers should not be insulated from liability just because there was a powerful incentive for them to behave badly.
I feel that the best way of thinking about regulations is to discard the lens of public and private organizations entirely; corporations frequently do the work of government and vice-versa.
Drafting regulations– or eliminating them– is dull, thankless work that usually requires a very specific skill set and a moderate to high level of intelligence. Think of it like RIAT, except in government, you don’t have to be as gifted as Mickey and the rest of the team were– very smart, but not crazy smart. What’s essential is the right attitude, the willingness to engage with detail. It’s one of those jobs where it’s critical for the right old people have to hire exactly the right young people and watch them closely, because errors will not be immediately evident. They can only be spotted by someone very skilled and experienced, and must be corrected with a sure hand and extraordinary reserves of patience.
The problem is that those who would do it best generally would much prefer to do something else. We’d rather be rock stars or crime fighters or spacemen.
This was pretty much my own attitude, by the way, until about five years before I stopped drinking and smoking weed.
“Obama’s EMR mandate was obviously a disaster, but we can’t let Epic and AllScripts off the hook.”
If you hate corrupt businesses, you ought to hate big government.
Doctors didn’t choose Epic, it was forced upon them. I would have never chosen it, mid eighties DOS programs were better.
http://www.motherjones.com/politics/2015/10/epic-systems-judith-faulkner-hitech-ehr-interoperability
That’s Mother Jones, a left leaning publication.
Great, any patient who takes a new drug on the market is at great risk. Of course, with so many people losing their health insurance, it might not be an issue due to the drugs being unaffordable.
Yeah, I know drug prices are going to be reduced under T. That has about as much of happening as my becoming a millionaire.
If the rulebook is 9000 pages, no one understands it and it’s written by lobbyists. The definition of regulatory capture.
If it’s 100 pages, it’s possibly understandable and manageable.
Bigger isn’t necessarily more effective. Complexity in nature is beautiful and functional (because of natural selection, maladaptive goes extinct), when designed by man it’s a mess.
This principle applies to EHR and MOC and any medical bureaucracy by the way.
“Complexity in nature is beautiful and functional (because of natural selection, maladaptive goes extinct), when designed by man it’s a mess.”
Agreed– with caveats. Even natural evolution has multiple failure modes– simple errors in cell division, or maladaptive traits can sometimes be passed down to the next generation, though usually only as an epigenetic potential.
Humanity’s attempts at complexity certainly have a far higher failure rate, but we don’t always get it wrong. Some systems are, of necessity, fiendishly complicated.
Sure, we all think of the DMV when we think of government systems and regulations– or the BOP or BBS, etc. (Some of you remember the state that I got into during the licensing process!)
OTOH, there’s the Deepwater Horizon Emergency Response Manual– that document came from the private sector (though it’s the kind of bloated, overwrought document you might expect a public agency to produce), and played a huge role in the disaster. Talk about a 9000 page rule book! I’ve only skimmed it, but it’s fascinating to see how a deficient, overly complex system evolved and negatively impacted the work environment on the rig, rendered the command structure opaque, and made reporting safety issues far more difficult.
Two other examples that come to mind are space travel and nuclear power; I’d much rather live near just about any reactor designed and maintained by the Navy than a GE Mark I or even Mark III. And I’d feel a lot safer flying NASA than Space X, though neither of them is showing up on my Expedia searches just yet.
See? I wasn’t kidding. I guess I still do want to be a spaceman. *sigh*