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WASHINGTON — President Trump on Thursday blasted pharmaceutical companies for having “rigged the system” against American consumers by charging higher prices in the U.S. than they do abroad, announcing a new proposal he says will help even out those differences.

“We’re taking aim at the global freeloading that forces American consumers to subsidize lower prices in foreign countries through higher prices in our country,” Trump said. “It’s almost unimaginable that it hasn’t been taken care of long before this.”

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  • There is not much room for Facts, with the Industry Trolls here. The reason we have the most expensive and least effective healthcare in the developed world, is that too many Industry insiders have had to much influence on policy. In their view all regulations are bad, healthcare is a free market, and it should be a “Choice.”
    Nearly every decision made in the last 2 decades, was overly influenced by pharma insiders, or other profiteers. At the same time, they influenced data collection, making it difficult to tracks the effects of these bad decisions. Mass media doe not cover any of this objectively, they are just as invested in pharma profiteering in as insiders like Alex Azar.
    It is nearly impossible to track the number of dead Americans or the true costs of these out of control industries. No one is allowed to question the marketing, misleading news releases, or even the industry funded academic research, that gets amplified by the media, if it supports industry profiteering.
    There was no real response to Insulin prices as they rose exponentially. Medicare Part D was designed to help big pharma profiteering. American have a huge blind spot when it comes to Medicare paying for these over overpriced drugs. They chose to demonize the elderly or sick people instead of look at any of this objectively. Here in Post fact America, even the brand names involved in deaths are secret.

  • Ms Ruwart,

    It is human nature to remain in denial and justify how your way of enjoying a nice lifestyle contributed to the deaths of thousands of Americans. There may be some regulations that could be updated now that we have sophisticated data and computer technology. Of course that is not what is really driving u the costs. Pharma spends more on advertising, buying public officials and marketing than they do on ‘Regulations.” Here in post fact America, anyone can write a book, and there is a lot more money in industry propaganda than fact based discussions.

    Pharma made sure that Industry insiders are now at the FDA, and the prices went up. The prices on drugs that were approved decades ago, and needed no regulations. Most of the more enforced regulations protect the pharma industry, as we have seen with the patenting, and legalizing of deceptive marketing. Pretty much every argument presented by the industry is a lie or half truth. That is why the prices continue to rise and the American public is demanding Universal Healthcare.

    • You have it exactly backwards, Marvis. The 1962 Amendments to the Food & Drug Act have shaved 5-10 years off each of our lives, including yours. Many of the complaints you have about the pharmaceutical industry are due to its reshaping by these regulations—including soaring pharmaceutical prices (https://www.statnews.com/2018/10/01/changing-1962-law-slash-drug-prices/).

      For example, before the Amendments passed, 10% of FDA officials leaving the agency from 1959 to 1963 went into the pharmaceutical industry. By 1969, that percentage had increased to an incredible 76%. As far as the “revolving door” between the FDA and the drug industry goes, it hardly existed until after the Amendments. The Amendments complicated development so much and the FDA at that time was so arbitrary in its dealings with the industry, that drug companies brought in former FDA personnel to help them deal with the regulations.

      Before Amendment passage, the company I worked for still developed drugs without patents. By the late 1970s, however, development costs had risen so much that we could no longer take unpatented products to market and hope to recover our costs.

      The regulations have often made older generic drugs unprofitable. When only one manufacturer is left making them, investment companies seek to acquire sole distribution rights and then hike the price up. Daraprim is an example of this. When the FDA drags its feet on approving competing products, companies that are the sole supplier can hike their prices too. This is what is happened with Epi-Pen.

      In all fairness to you, this information isn’t all that easy to come by, although to its credit, STAT has covered a great deal of it. I wrote “Death by Regulation” so that people could hear a side of the story that is rarely, if ever, heard. You don’t have to take my word for anything, though; the 525 references in the book document my assertions. If you want to be well-informed on how the Amendments have taken years off all of our lives, you may want to check it out.

    • Ms Ruwart,
      You are either a Pharma paid Troll, or seriously misinformed. It is really clear that your Anti Regulation hero, is incapable of comprehending the complexity of the Pharma Industry. The industry think tanks and right wing media employ very clever marketers who use all kinds of cognitive tricks to get gullible people to believe things that are not factual. Of course when that doesn’t work, they have their propaganda mouthpieces repeat it enough times so that ignorant people believe up is down, and the earth is flat.

      Repeating this nonsense does no make it so!

    • Marivs, I’m certainly not a Pharma-paid troll; it cost me a great deal of time and money to put out the book, “Death by Regulation,” with its extensive documentation. I undertook this project because much of this information is unavailable to the public and there are few people who have the background to write it. Far from being misinformed, I have knowledge that few people have. Without that information, attempts to better the system are doomed to fail. We ignore it at our peril.

  • A big part of the problem in the US is that the cost of meeting FDA regulations to take a drug to market is going up exponentially each year and those costs get passed on to consumers in higher drug prices (https://www.statnews.com/2018/10/01/changing-1962-law-slash-drug-prices/). As regulatory costs have increased, the number of drugs that fail in development has fallen; about half of these fail, not because of safety and effectiveness, but because companies know they won’t be profitable. As a result, investors demand a higher return. If these regulations gave us more safety and effectiveness, they might be justified. However, as the article cited above shows, these added regulations, their costs, and the resulting higher drug prices don’t give us improved safety or effectiveness. Unless these excess regulations are dealt with, lowering drug prices will indeed result in less innovation.

    • That is simply not true. That is what the mass media and the pharam industry has been telling gullible people, and getting their paid trolls to regurgitate on sites like this. Most of the drugs approved lately are not even new, they are just repackaged old drugs, with a slight change that does not require any testing. The pharma industry always leaves out the fact that most of these drugs, and the research that led to them, was paid for by the American people. Taxpayer funded research bought America to the forefront, globally, but our corrupt Pharma industry with the backing of profiteers that own our media have told a different story.
      Perhaps you should quaint yourself with the facts, before posting here with nonsense or propaganda directly from Pharma. This is the reason the price of Insulin has gone up 7000 percent.

    • Mavis, I spent close to two decades in the pharmaceutical industry, so I am well aware that every year the FDA’s regulatory demands increase. The time we took to meet these regulations absorbed time that would otherwise have gone into discovering new drugs and deterred us from developing them when we did. Studies show that we’ve lost at least 50% of our innovations; I suspect that actual number is closer to 80%. No one in the industry dares to speak out because the FDA can punish whistle blowers by slowing the approval process. Consequently, how these regulations have reshaped the drug companies, the medical profession, and the prevention industry and cost each of us at least 5 years of our lives is a well-kept secret. All this is documented in my book, “Death by Regulation: How We Were Robbed of a Golden Age of Health and How We Can Reclaim It.” This is a side of the story that very few people could write about, which is why I spent several years doing it. Someone has to speak out. Rather than denying the reality of what I’m saying, check out the book and it’s 525 references. The penalty for each of us for not dealing with these deadly regulations is the loss of years of our lives.

  • This has been one of the most obvious questions when it came to pharmaceutical prices, yet it is suddenly an issue. Even more telling is Azar’s reaction, typical for a pharma insider. Most Americans have been seriously misinformed and mislead about this debacle. Real lives are impacted by the For Profit model, real people die, everyday. the USA has the worst outcomes of any developed nation. Instead of fixing the system, these ghouls are using a piecemeal approach, to protect corporate interests.

    • Mary and Mavis:

      Misinformation is the key. Most news reporters have not much clue of the technologies or drugs or manufacturing or regulations. They just polish and write to make sure readers and investors have something to read about.

      Regulations and regulators are part of the problem. Regulators don’t understand manufacturing technologies as they have never (or very few), developed, designed, commercialized or managed a pharma manufacturing plant and here they are suggesting what technologies they should use. Most of the technologies they suggest cannot be financially justified. In addition they are telling that their processes should be up the snuff. Irony is that the fundamental ethics of developers and designers is to have process that will produce quality product. My guess is that close to FEW BILLIONS have been spent by the pharma companies trying to recheck and assure they have the best even when they had the best. Wheels are spinning at the companies, universities and the equipment supplier companies on things that are in use and work but are being sold under a new BUZZ word.

      FDA demands details of the manufacturing be submitted and they delay the approval process. Many at FDA do not understand the information as they have never been on a manufacturing floor or designed a process or a product. Irony is
      when a company brings the process for they have total command of the process. Yes cGMP is a must but that is companies responsibility. If the product if off-spec, FDA should shut the plant down.

      My thinking is that FDA should approve the manufacturing in THREE months. What Is Needed for a Regulatory Approval of NDA/ANDA Filings in 90 Days?
      https://pharmachemicalscoatings.blogspot.com/2018/10/what-is-needed-for-regulatory-approval.html

      Companies are developing and selling orphan drugs at exorbitant prices for less than 200000 patients and going to the bank laughing. They have not developed or commercialized many drugs that will serve FIVE plus million patients. Everything they have is marginally better but expensive. Revenue is more important and it should be but the question is should it be doing things that have no or minimal return. FDA has pharma companies wrapped around their fingers. FDA says jump and companies are jumping without thinking or asking a question “what is the value and return of the jump” .

      Mary your book does bring out questions. There is lot of smoke in front of reality.

      I don’t think much will change in our legally corrupt system when the legislators are in bed with the various lobbyists.

    • Girish,

      I appreciate your comments. Manufacturing issues created by the 1962 Amendments are costly, as you’ve pointed out, but it’s tough to determine just how costly. I appreciate your attempt to put them in perspective.

      Manufacturing costs aren’t even included in the R&D estimates of taking a new drug (NME) to market, which these days are close to $3 billion, including the cost of failures.

      One of the reasons that it takes so long for the FDA to approve a new drug is that it must review the studies that it demands from the drug companies, which include purity and chemical composition, animal studies, and clinical trials. The volume of material submitted to get an NDA is literally a truckload or its equivalent in electronic documents and takes well over a decade for drug companies to accumulate. An ANDA, for readers who might not know, is an “Abbreviated” NDA, so 90 days should be sufficient. My understanding is that they now take as long to review as an NDA.

      I certainly agree with you that misinformation is rampant, through no fault of the reporters themselves. Even if they want to get the details, it’s tough because the industry dare not share the problems with regulations, for fear of retaliation. It sounds self-serving for drug companies to criticize the FDA. However, some regulators have gone on record acknowledging that delays in approvals mean that people who could have been saved die prematurely.

      As a nation, we seem to believe that regulations make us safer, even ones that delay our access to new medicines, destroy innovation, and censor truthful, life-saving information about drugs and supplements, even as they raise costs beyond what the average person can truly afford.

      Regulations can be just as deadly as bad drugs. As you know, I estimate that we’ve each lost 5-10 years of our lives to the 1962 Kefauver-Harris Amendments to the Food & Drug Act alone. If a food, supplement, or drug resulted in that much loss of life, it would be quickly withdrawn. However, we don’t seem to be willing to even consider examining regulations that do the same.

      The Orphan Drug Act was put into place to encourage companies to engage in innovation that was made economically unfeasible by the 1962 Amendments. As is often the case, trying to correct misguided regulations with more regulation can backfire. We now have some orphan drugs that weren’t going to be developed due to excess regulation, but we pay a staggering price. Why not just reconsider the regulations that cause the problems in the first place?

  • So it is crunch time for the mid-term elections with health care (and the attack on preventing ending coverage for pre-existing conditions) the hottest issue. So enter Agent Orange with a ‘fix’ for drug prices that seems to be oddly circular. Drug prices in many countries are lower for many drugs than in the US…I’m not sure but I would expect that many of these countries allow bargaining for the price. The US does not allow Medicare to bargain for a central price…why don’t we fix the US problem by allowing Medicare to bargain…In stead we get Trump spouting a policy melange more to build a fire break against a mid-term rejection of TRUMP. C’mon, this is not serious. This is more Agent Orange’s attempt to distract and deflect. IMHO.

    • George there are many issues. I did review some of issues you have raised. My perspective is outlined in the linked article.
      Opportunities to Lower Drug Prices and Improve Affordability: From Creation (Manufacturing) to Consumption (Patient)
      https://pharmachemicalscoatings.blogspot.com/2018/03/opportunities-to-lower-drug-prices-and.html
      If you look at the tables you will see that the supply chain is hiding behind Pharma companies and taken patients for a ride in the mutually subsidized healthcare system. In addition we have two very significant lobbies in our legally corrupt political system. Our legislators are paid by these lobbies to retain their jobs so that they can make sure profitability of pharma related companies is not lowered.

      If drug prices were controlled as they are done in Europe and Canada many of the issues will disappear. Yes pharma and many others will say innovation is out the window.
      Another issue we have to recognize that many of the drugs are marginally better than extremely cheaper drugs and very few doctors would prescribe them for their high prices.
      There is a big debate and it will be fascinating how it settles. Cheers.

  • Excess US prices are not subsidizing research or lower prices in other nations. See Donald Light’s meticulous papers on this issue.

    The excess prices go to profits for CEO’s and investors. In other words, the sick are subsidizing the retirement plans of most affluent Americans, since every diversified portfolio has drug stocks. It’s just another way we redistribute income to the wealthy and generate income inequality.

  • It is an interesting proposal. Patients in the US pay the highest for the Brand drugs. We have to recognize that US makes less than 5% of the population. Developed countries make about 20% of the population. Prices are the highest in US and then the other developed countries. Big Pharma wants to sell the drug to the 80% also but they can’t afford the developed country prices. Thus to have the plants operating and pay the fixed costs BIG pharma sell to the developing countries at lower prices. Pure economics. Bis pharma does not want to accept that selling world over might give them a much larger patient base and higher revenue and profits. However, this is not the model BIG pharma understands. There is a reason for that also. Long approval time that shortens US patent life. Thus to recoup the revenue FAST they sell in the developed countries at the highest prices. Pure economics 101.

    Generics the developed countries consume come from the developing countries and they could be sold at almost 10% of the current selling prices if one did not have healthcare insurance but PBMs and allies jack the prices to make it look like US patients are getting a deal.

    Let’s see how the BIG pharma reacts and how the legislators who are in the back pocket of pharma shield their financier, BIG Pharma.

    Life will get interesting.

  • As a European I find myself often reflecting about the huge amount of money pharma companies make on medications sold in the EU.
    But than I look at the US and think that’s banana!
    Paying for drug R&D? Right …. high US prices are paying for c-suite and investors Mar-a-Lago Golf club membership

    It feels good being a freeloader!

  • Firstly, I cannot tolerate the photograph alone, as something that is associated with this evil creature; I looked at it briefly. What I saw, was the beginning of what would barely be done to become a nazi salute for Hitler. This is exactly the way that this creature wants all of us to do, for him? I have no doubt about this initial impression that I perceive.

    Segway to the second point about this topic; I have never believed an utterance from this idiot’s huge mouth. It doesn’t take a genius, or a psychotherapist to recognize the most egregious, lying and appalling negativity that this ? is responsible for the destruction of our nation, and especially for our democracy. I don’t want to know what this ? writes, reads( which I doubt he has the skills required to read and comprehend what he has just read ), not what he states about everything. Especially because the same bs, typically changes before the article is in print.

    I truly believe that if everyone in the USA ( and hopefully the rest of the world too ), totally ignores this ? for one solid week, he would probably explode with his hubris that would hopefully be the first time he has ever known the negative consequences for his own terroristic behaviors. The topic is meaningless because of who is doing the same old same old bs, never with any follow through, anyway. I rely on the professional journalists, who are amongst the most heroic individuals in this nation and throughout the world, for their respective experiences and information that they know to be accurate or just another of countless lies that are uttered by this ? Never ending bs, every time it opens it’s mouth. I appreciate the journalist who wrote this article about the topic. Thank you for your doing what I am not ever going to do again, nor do I seldom have ever done before anyway.

    • Thank you for the spelling course; I wrote about the numerous times that I write the word correctly, and it shows as a totally different word? Guess you haven’t read the majority of the comments that we are aware of this phenomenon? I hope this made you feel very happy. Plus way to deflect the topic away from the discussion; just like dt.

  • If the government has to cover every FDA approved drug as stated in the last line, how will this really work if companies don’t agree with the lower price? European countries are willing to walk away and not cover certain meds, something that may not be acceptable to US seniors.

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