Posted on 01/31/2017 10:29:16 AM PST by ColdOne
President Trump told pharmaceutical executives Tuesday he wants lower drug prices, and he pledged that the government will speed up approval times for new medicines.
“You folks have done a terrific job over the years, but we have to get prices down for a lot of reasons,” Mr. Trump said at the White House. “We have no choice. For Medicare, for Medicaid, we have to get the prices way down.”
The president urged the executives around a conference table to bring back their manufacturing operations to the United States, promising to cut regulations and speed up the Food and Drug Administration’s consideration of new drugs. He said it’s “disgraceful” that companies spend on average $2 billion to develop a drug and can wait as much as 15 years for a final decision by the FDA.
(Excerpt) Read more at washingtontimes.com ...
Everyone needs a flu shot now. Those FREE flu shots are not free....they're government subsidized..
I'm glad that he recognizes that there are significant costs that go into developing medicines, and pharma companies should have the opportunity to make up those costs--as well as fuel further research and development.
With all due respect, if that's as far as you see, you have a lot to learn about drug development and the costs to bear it.
Yes, governments "buy" a lot of pharmaceutical products, and they get their own special pricing. The reason they buy a lot is that they've taken the position of being involved in healthcare. I am not going to argue whether that's ideal.
As far as research grants, yes, the government also throws a few pennies around to target specific diseases. There are many doctors in academia that write protocols for clinical trials, and they too, may receive grants for their work. But for the most part, the study drug is underwritten by pharma companies.
And while governments may throw a little "seed money" around for initial research--pharmaceutical companies bear the costs of large, late-phase clinical trials. The kind of trials that take place globally, in dozens of countries. These trials are supremely costly because they involve payments to primary investigators and their staffs (customary and usual payments, not payoffs), the cost of lab tests and kits, costs associated with manufacturing and packaging and distributing clinical supplies, the costs of comparator drugs and supplies, and the costs of "keeping the lights on" year after year, while they're testing the study drug's safety and efficacy.
Oh, and even after years of testing, a drug may prove that it's not quite as safe, or maybe it's not quite as efficacious as another product. The FDA may not approve it, or they might approve it, and the product is a commercial failure. There's a lot of risk involved in drug development, and it's fair that pharma be able to make a little money off their ventures.
I’m glad that Trump is asking for this. If the drug companies comply, it’ll be on very few drugs, and to only a minimal extent - but I’m hoping for a catagorical refusal.
Why? Because these drugs are all price-fixed, that’s why. I’d LOVE to see AG Jeff Sessions instigate an investigation into the monopolistic practices of ALL drug companies - and end up breaking them up and making whomever survives subject to the law, just like everyone else. Followed up by a similar investigation into hospitals, health insurance companies and at least a few medical practices in each and every state.
What is making us go broke on medical care is the complete and utter failure of the federal government to enforce anti-trust LAWS against the various actors in the medical industry. If that isn’t fixed (i.e. eliminated, on threat of prison time), then we will NEVER solve our fiscal woes, not even with a repeal of Obamacare. There will simply be NO FREE MARKET until and unless price-fixing in the medical/drug industry is actually prohibited (as opposed to theoretically prohibited).
"...starting with the research grants."
Simply put, the states have never expressly constitutionally delegated to the feds the specific power to tax and spend for the purpose of funding pharmaceutical research.
“Congress is not empowered to tax for those purposes which are within the exclusive province of the States.” —Justice John Marshall, Gibbons v. Ogden, 1824.
”From the accepted doctrine that the United States is a government of delegated powers, it follows that those not expressly granted, or reasonably to be implied from such as are conferred, are reserved to the states, or to the people. To forestall any suggestion to the contrary, the Tenth Amendment was adopted. The same proposition, otherwise stated, is that powers not granted are prohibited [emphasis added].” —United States v. Butler, 1936.
So patriots need to support President Trump to either peacefully "force" the corrupt feds to stop appropriating taxes in the name of pharmaceutical research, or work with the states and Congress to see if the states would be willing to ratify an appropriate amendment to the Constitution so that Congress can legally appropriate taxes for such funding.
"The States should be left to do whatever acts they can do as well as the General Government." --Thomas Jefferson to John Harvie, 1790.
"In every event, I would rather construe so narrowly as to oblige the nation to amend, and thus declare what powers they would agree to yield, than too broadly, and indeed, so broadly as to enable the executive and the Senate to do things which the Constitution forbids." --Thomas Jefferson: The Anas, 1793.
I was in “Big” Pharma for 38 years, just retired in December.
I can’t count the numbers of new products that I have worked on over the years. As a QA supervisor, production manager, Technical Lead and SME I have developed and implemented container closure systems to assure safe and pure pharmaceuticals are available to the patient.
As a program manager, I was responsible for design and installation of new production lines to make these new produts. The EQUIPMENT alone cost $165 MILLION dollars!!
Add in the cost of clinical trials and all the people it takes to run a New Product Team and $2Billion is small change...
I estimate that over my 38 years in the biz, I was responsible for the strength, quality and purity of over 9.11BILLION doses of various injectable drugs...and I didn’t kill anyone by making a mistake.
That’s what we in the Pharmaceutical business really care about...making the product to highest quality and making sure it’s safe and ready for the patient every time they need it.
Our families are often the next inspector of our products!!
Bookmark
I think you've misread what Trump is saying. He's offered congratulations to the industry, acknowledging that pharma has produced good results. He also offered that we would look for ways to streamline the FDA processes around drug approval. While I applaud him for trying, I think he'll find that developing drugs is not like making candy. Still, I'm willing to try.
Trump also acknowledged that other countries are benefiting from our drug development, as well as what Americans pay in costs for pharmaceuticals. Foreign governments place many price controls on drugs, but the industry's hands are tied in many ways. We could walk away, but sometimes, getting some business is preferable to getting none at all. And for some products, it's too easy to counterfeit, too easy to import drugs in from somewhere else.
And if somehow, AG Sessions did as you suggested and "broke up" the industry and its "monopolistic practices," it would be revolutionary--he would kill the pharmaceutical industry in the process, but you seem too short-sighted to understand that.
No, the president has it more right than you do: we need to cut the cost of bringing drugs to market, while simultaneously removing the protections that allow pharma to force Americans to pay for the development while the rest of the world pays lower prices for the drugs.
He’s addressing both the cost and price sides of the equations at once, in essence as a deal.
Please...another person showing their ignorance on this subject. I'm a Trump supporter, but I know a little bit about the pharmaceutical business too.
First of all, the article said nothing about removing protections that allow us to force anything on the consumer. I don't know what protections you think we have.
For those with insurance, it's generally up to pharmacy benefits' managers (PBMs) and formularies that decide how much they'll pay for a particular drug. We can't just set a price and "force" someone to pay for it.
Sure, there have been a few isolated cases in the past year or so where some small company has jacked up the price of a single drug. Even in these cases, free market forces brought the prices down. The most recent story about Epi-pens became a non-story in a few weeks when generics offered significantly lower prices.
As for the rest of Trumps proposals, I welcome them. I think it will be a tall task though, getting other countries to "pay their fair share" when it comes to drugs. There may be other trade-offs that could could provide incentive for pharma companies to lower their costs and move operations to the US, but there are many valid reasons to maintain a global presence with our operations. The pharmaceutical business is complex and costly when it comes to drug development. It's not like making candy.
The issue is not being allowed to import drugs from countries where they sell their product at a cut rate. Lighten up there and they will have to offer us competitive prices too.
If a law/regulation required pharma companies to sell at the lowest price in the U.S. that the same drug is sold internationally, would that force other nations to help pay R&D costs.
As it is we pay and others prosper.
However, can you explain to me in layman's terms why the same brand name drug costs are much lower in other countries? I'm not talking generic...I'm talking Lilly, Pfizer, et al. As I'm sure you're aware, you can go to Canada or Mexico to get brand names, as well as on-line pharmacies in India, England, Philippines, etc. Yes, I know some are rip-offs; others are genuine. Thank you for any input.
No, that’s the tail wagging the dog...what we’d be doing is allowing the importation of price controls into the US. That could also lead to shortages as companies restrict what they sell overseas. If you don’t understand economics OR the drug industry, maybe you should ask someone for an explanation?
Simplest answer that I know to be true is the government subsidies and import rules are different in all countries.
For example, let’s pick Brazil an an example of an importing country. They buy from m USA at US pricing. People in Brazil then get a little markup but pay essentially the same as US.
Now, Colombia, let’s say, doesn’t have an import license for some drugs so they ask Brazil to sell to them in THEIR trade agreement. So Brazil sells it to Colombia at 5X the price!
It works so differently between so many countries, it’s really difficult to know. Finally, with insurance the sky used to be the limit.
Spare me, pal. We should let people buy their drugs across the border. Pharma is bloated and can choose to sell reduced cost drugs in other countries or not. But we should also reduce the burden of drug approval.
Hi, Navy Vet...thank you for your service. I too, am a Navy vet. Six years there, and now over twenty in the pharmaceutical business.
To add to GRRRR's explanation, most pharmaceuticals OUS are purchased by governments, and those governments have a big hand in the approval of the drug, as well as setting the price of the drug within those countries.
These countries use various formulas to determine the price--some of it has to do with the disease, how breakthrough the medication is, whether or not there are similar drugs available, and what the cost is to treat the patient without such a drug. These are all health outcome factors.
There's also something called "reference pricing," in which the price of a drug in country C might be determined by the average price of that drug in countries A, B, D and E. There are various flavors of reference pricing; e.g., 10% less than highest price, median pricing, etc.
You should also know that a drug doesn't necessarily become approved in every country all at once, and pharmaceutical companies may choose to restrict sales in some countries that won't pay a minimum price.
In many countries however, we'd rather sell at a lower price than not at all. Some of this is for business reasons, and some of it for ethical reasons. If you have a one-of-a-kind, life-saving oncology drug for example, it's very difficult to keep that from patients.
To your last point, there are other countries that appear to sell brand-named drugs at significantly lower costs. Some of it may be genuine, some of it may not. In many places, I would be highly suspect to put a questionable substance into my body as some sort of medicinal treatment.
In other countries, governments don't always recognize intellectual property that should be protected by patents. Unscrupulous companies are able to re-construct the chemistry behind many oral medications and manufacture counterfeit products. The active ingredients in these medicines may be effective and tested, or it may not. They may use cheaper excipients (the inactive ingredients within a tablet or capsule), and those may cause allergic reactions.
There are legitimate support infrastructures in place when you purchased licensed medications. Companies like mine field round-the-clock questions from pharmacists, doctors and patients. If you take a questionable medicine from a counterfeit on-line market, you'll likely not get the same kind of service.
The pharmaceutical industry is complex. We'd welcome a chance to streamline the costs to manufacture and support medicines, and we'd like to ensure that EVERYONE can afford them. But it's not cheap to discover, manufacture, test and commercialize medicines. It takes years, and there are costs involved. We ought to be able to make a profit as well.
What a joke—you’re the one trying to defend protectionism for your own business instead of allowing Americans to buy drugs from whomever they choose.
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