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ASHINGTON — President Trump has ambitious plans to overhaul the drug market, speeding approvals while bringing down prices. It sounds great. But soundbites can be deceiving. So we gave Trump’s rhetoric a reality check:

THE CLAIM: “They come with a new drug for a patient who’s terminal, and the FDA says, ‘We can’t have this drug used on the patient.’”

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  • The unarguable facts continue to be:
    1) Pricing in the USA is totally out of whack and unchecked by governmental forces, as compared to the UK, Switzerland, UK, Canada, New Zealand, and Australia. So, the American taxpayer subsidizes those other countries, while ensuring excessive profits of Big Pharma.
    2) Alleged cost of Big Pharma’s R&D inflated due to hefty expenditures for lobbying and advertising.
    3) Drug production inappropriately moved offshore to countries with questionable health and sanitation standards. Such offshoring actually has diminished quality controls, while exposing Big Pharma to higher risks of illegal, pirated drugs.
    4) Without the pharmacy benefit managers, who would have the capacity to sit at the negotiating table with the 900 lb. gorilla, Big Pharma? Their needs to be a forensic audit to clarify what the exact cost impact is for our drugs as alleged to the PBM.

    • “The unarguable facts continue to be” …your opinion
      1) American taxpayers are not subsidizing other countries, that’s your xenophobia – American taxpayers are simply paying over the odds
      3) “Drug production inappropriately moved offshore to countries with questionable health and sanitation standards” – your xenophobia again! German, French and UK production standards are at least as high if not higher that those of the US.
      “offshoring has diminished quality controls, exposing Big Pharma to higher risks of pirated drugs.” There is no relation between the two.
      Report: need to be more objective

  • The underlying statement of the article seems to be this: America is doomed in this regard. What Trump claims won’t work; those before him in the past decades failed with whatever efforts they exerted; solutions to the problem are nowhere to be found from anyone, any organization, any industry, any administration. This is, indeed, a bleak and worrisome picture. Does anyone have any trustworthy, believable, workable “soundbites” that can hold up to the reality?

  • My apologies for low balling the cost of the bioreactor. You don’t just build one at a time. Genzyme’s bioreactor plant in Allston housed six reactors at a total cost of $200,000,000. So when they charge $300,000 for a 28 day course of enzyme replacement for Pompe Disease I hope you will be a bit more circumspect. As a chemical engineer you can understand that certain manufacturing processes simply cannot be rationalized by their very nature.

    http://www.bizjournals.com/boston/stories/2002/10/14/story2.html

    • Somebody got taken for a wild ride. Read the report and it says two reactors cost $30 million. Facility cost $200 million. Still I am from old school and I would say overspent and underutilized facility. Something is not kosher.

  • Ideas like these may work well on an episode of “The Apprentice” but we’re all living in the real world and not on the set of a vacuous TV show.

    The most amusing of the thought bubbles was “We’re going to be ending global freeloading … [and] foreign price controls [that] reduce the resources of American drug companies to finance drug and R&D innovation.”

    Really? So, every country that has established proper pricing and reimbursement schemes for medicines has to dump their scheme to introduce the rubbish system the US has at present or some other rubbish that the White House dreams up? Yes, I can see that working!

  • I would beg to differ with the claim that manufacturing is expensive. That is completely irrational claim. All depends on the product and with economies of scale very creative and economical processes can be lower costs. Pharma’s modus operandi has been “product quality by analysis paralysis” and that has to go. Pharma can learn a lot from its older cousin fine/specialty chemical industry. Pharma is not a prima donna.

    Innovation is needed and we can deliver. We have to remember we took the man to moon and brought him back. We can and have created very economic processes.

    If some says manufacturing is expensive then that is an opportunity for the chemists and chemical engineers to create economic processes. Enough said.

    • You can’t apply economies of scale to large molecule manufacturing. You will spend $50,000,000 to set up a bioreactor, and it has to be dedicated to a single molecule. You can manufacture large quantities of proteins in a short manufacturing cycle, and the rest of the down time is sunk cost.

  • Another reality check for DT. Since drug stability testing is very expensive, once the word comes down that a particular drug ceases development the registration batches hit the trash and no new stability testing is begun. The longest dated expiry extant on the day of program discontinuation becomes the date after which no drug will be shipped, and most of the time drug supply runs out long before that. No Don, it’s not a case of “Johnny’s in the basement mixing up the medicine” for granny’s right to try.

    • Or there is a precise number of clinical kits packed and counted per good clinical practice, and everything else is in bulk and unpacked in some deep GMP storage, and now some right-to-try wants 5 10 20 of them? Possible, but needs quite a bit of logisitics.

    • I am from an old school and would really look at the investment of $50,000,000 for a bioreactor for and rationalize the process to do things differently. I would do the best to avoid such a large waste. That is me.

  • We have to many for-profit middlemen (PBM’s, insurance, etc ) between the manufacturer and the pt. When they weren’t in the distribution channel – before 1970 – the average prescription price was $4-$5 and there was virtually NO GENERICS… today the average prescription price is pushing $60 and we have 85% generic utilization and the middlemen have to take their “cut” to support their overhead infrastructure and bottom line. They were able to infiltrate the distribution channel by promising to save the overall system money. Which seems to have proven to be a “Trojan horse”

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