Skip to content
  • About
  • Contact
  • Contribute
  • Book
  • Careers
  • Podcast
  • Recommended
  • Speaking
  • All
  • Physician
  • Practice
  • Policy
  • Finance
  • Conditions
  • .edu
  • Patient
  • Meds
  • Tech
  • Social
  • Video
    • All
    • Physician
    • Practice
    • Policy
    • Finance
    • Conditions
    • .edu
    • Patient
    • Meds
    • Tech
    • Social
    • Video
    • About
    • Contact
    • Contribute
    • Book
    • Careers
    • Podcast
    • Recommended
    • Speaking

Inhaled medications: Nefarious reasons for the lack of competition

John F. Hunt, MD
Meds
August 29, 2014
Share
Tweet
Share

Check out the prices for nebulizer solutions of albuterol and budesonide (generic Pulmicort). They are totally affordable. $4 for a month for albuterol. $14 for a month for budesonide respules. Pulmicort respules used to be very expensive. Now even the branded budesonide is  less than 10% of a monthly cable bill.

Then check out the prices of inhaled steroids delivered through meter dose inhaler (MDI) or dry powder inhaler (DPI). These run $200 or more per canister. They aren’t coming down in price. If you are prescribed any of these you might have to cut back 50% on your monthly cigarette budget to afford them.

Why are nebulizer prices now so low, while the MDIs and DPIs remain very high?

Budesonide went off patent and now generic nebulizer solution competes with Pulmicort respules and the prices fall to affordability.

But budesonide as an API (active pharmaceutical ingredient) is off patent, so why is there no DPI or MDI version of it being made by the generic manufacturers? Pulmicort flexhaler (DPI) still costs about $200. And fluticasone is an old drug now (brand: Flovent) but where is the generic? And QVAR comes out expensive too, even though that drug (beclomethasone) is essentially an antique.

The answer is that the FDA regulations for DPIs and MDIs cost huge sums of money and take huge efforts to comply with. These regulations are mostly for the purpose of assuring that the doses squirted or sucked out of these devices are within 15% of the intended dose. That’s a 15% tolerance. So many millions of dollars and thousands of man-hours are required to abide by these regulations that generics simply cannot afford to enter the market.

And big pharma loves that! They all sell their MDIs and DPIs, charging all roughly the same $200. There is no generic competition because the crony government agency for whom so many of the pharma regulatory personnel once worked is doing a great job of keeping out competition.

And the value to the patient of this crony-regulatory agency sticking its nose in? Pretty much nothing. Here’s why.

The deposition in the airways in any individual patient from the newer HFA MDI inhalers varies from 0% to as high as 50% of the drug squirted from the nozzle. It’s similar for DPIs. Even for patients using them “correctly” it is still a 10-fold range in lung-deposited drug. The 10-fold variability in drug deposition that exists even within “correct” or “tolerant” human-device interaction overwhelms any paltry contribution to consistency provided by a 15% tolerance on the drug squirting from the device.

All those regulations and controls demanding 15% tolerance suddenly seem entirely wasteful when the reality is the human physiologic tolerance is overwhelmingly greater. I think the phrase to describe FDA’s value is “pissing in the ocean.”

And on top of this, as physicians we should not be settling on our dosing of bronchodilators and steroids based on some groupthink average determined by a dosing study in a population that did not include our patient. Rather we should be using those sources to provide rough guesses, but should be dosing “to effect” as each patient’s lung deposition varies. Plus, each patient’s disease requirements are different, and change over the days and weeks and months. For bronchodilators, we get feedback in hours or days. For steroids in days to weeks. None of these requirement for frequent dosing adjustments are obviated in any way by a set of tight tolerances for the micrograms squirted out of the device.

It turns out that the precision of the amount squirted out of the device is one of the least important determiners of how many puffs a patient needs.

Sure, it is nice to have some pretty good consistency in how much is squirted. We might barely start to notice (maybe a tiny little bit) if tolerances were far beyond 50%. But I bet generics could come in fine with a pretty good product, at 20% or less of the price point of the current drugs, if they weren’t hamstrung by the FDA’s regulations that were written to protect big pharma from competition. And the patient and system benefits of this price competition would far outweigh the marginal loss of control over the amount that is squirted out of the device.

ADVERTISEMENT

Yes there are other regulations in the FDA’s controls too, for example to make sure that the drug particle size is optimally respirable. But those processes are all normal parts of responsible drug development, without the FDA mandating or approving any of it. If companies don’t have the government protecting them, the only way they can make a profit in a competitive and free environment is to optimally serve their customers needs, and that means making the best product possible. And that has nothing to do with FDA regulations.

Oh, and if you think that big pharma and FDA don’t collude? Take a guess at what organization pushed the hardest for the banning of chlorofluorocarbons from MDIs in order to save the ozone layer from the tiny fraction of CFC’s released each year that were attributable to MDIs. I won’t say the name. They were one of the biggest producers of CFC albuterol MDIs, but had invested in their new HFA MDI manufacturing set up and were jumping at the opportunity to rebrand what had essentially become generic albuterol puffers. With the help of EPA and FDA they accomplished their goal with aplomb, shooting the prices of inhalers, and their profit margins, up to the sky. All without benefiting a single patient at all, and having essentially zero impact on preserving the ozone layer.

The FDA is unconstitutional anyway. All the inhaler shenanigans of the last two decades are just more items in a long list of reasons to question the safety and efficacy of FDA.

John F. Hunt is a physician and author of ASSUME THE PHYSICIAN: Modern Medicine’s “Catch-22″.

Prev

2 ways to improve doctors: feedback and reflection

August 28, 2014 Kevin 0
…
Next

Why Liberians raided the Ebola clinic

August 29, 2014 Kevin 5
…

Tagged as: Medications, Pulmonology

Post navigation

< Previous Post
2 ways to improve doctors: feedback and reflection
Next Post >
Why Liberians raided the Ebola clinic

ADVERTISEMENT

More by John F. Hunt, MD

  • a desk with keyboard and ipad with the kevinmd logo

    The legal system has serious problems, but who are we to complain?

    John F. Hunt, MD
  • a desk with keyboard and ipad with the kevinmd logo

    A nurse masters the art of medical slang

    John F. Hunt, MD
  • a desk with keyboard and ipad with the kevinmd logo

    The cheapest form of health care is to let sick people die

    John F. Hunt, MD

More in Meds

  • The diseconomics of scale: How Indian pharma’s race to scale backfires on U.S. patients

    Adwait Chafale
  • A psychiatrist’s 20-year journey with ketamine

    Muhamad Aly Rifai, MD
  • How drug companies profit by inventing diseases

    Martha Rosenberg
  • Every medication error is a system failure, not a personal flaw

    Muhammad Abdullah Khan
  • Why kratom addiction is the next public health crisis

    Muhamad Aly Rifai, MD
  • FDA delays could end vital treatment for rare disease patients

    GJ van Londen, MD
  • Most Popular

  • Past Week

    • The human case for preserving the nipple after mastectomy

      Thomas Amburn, MD | Conditions
    • Nuclear verdicts and rising costs: How inflation is reshaping medical malpractice claims

      Robert E. White, Jr. & The Doctors Company | Policy
    • How new loan caps could destroy diversity in medical education

      Caleb Andrus-Gazyeva | Policy
    • IMGs are the future of U.S. primary care

      Adam Brandon Bondoc, MD | Physician
    • How I learned to love my unique name as a doctor

      Zoran Naumovski, MD | Physician
    • From nurse practitioner to leader in quality improvement [PODCAST]

      The Podcast by KevinMD | Podcast
  • Past 6 Months

    • Health equity in Inland Southern California requires urgent action

      Vishruth Nagam | Policy
    • How restrictive opioid policies worsen the crisis

      Kayvan Haddadan, MD | Physician
    • Why primary care needs better dermatology training

      Alex Siauw | Conditions
    • New student loan caps could shut low-income students out of medicine

      Tom Phan, MD | Physician
    • Why pain doctors face unfair scrutiny and harsh penalties in California

      Kayvan Haddadan, MD | Physician
    • Love, birds, and fries: a story of innocence and connection

      Dr. Damane Zehra | Physician
  • Recent Posts

    • How I learned to love my unique name as a doctor

      Zoran Naumovski, MD | Physician
    • My first week on night float as a medical student

      Amish Jain | Education
    • What Beauty and the Beast taught me about risk

      Jayson Greenberg, MD | Physician
    • Creating safe, authentic group experiences

      Diane W. Shannon, MD, MPH | Physician
    • The diseconomics of scale: How Indian pharma’s race to scale backfires on U.S. patients

      Adwait Chafale | Meds
    • Healing from medical training by learning to trust your body again [PODCAST]

      The Podcast by KevinMD | Podcast

Subscribe to KevinMD and never miss a story!

Get free updates delivered free to your inbox.


Find jobs at
Careers by KevinMD.com

Search thousands of physician, PA, NP, and CRNA jobs now.

Learn more

View 5 Comments >

Founded in 2004 by Kevin Pho, MD, KevinMD.com is the web’s leading platform where physicians, advanced practitioners, nurses, medical students, and patients share their insight and tell their stories.

Social

  • Like on Facebook
  • Follow on Twitter
  • Connect on Linkedin
  • Subscribe on Youtube
  • Instagram

ADVERTISEMENT

ADVERTISEMENT

  • Most Popular

  • Past Week

    • The human case for preserving the nipple after mastectomy

      Thomas Amburn, MD | Conditions
    • Nuclear verdicts and rising costs: How inflation is reshaping medical malpractice claims

      Robert E. White, Jr. & The Doctors Company | Policy
    • How new loan caps could destroy diversity in medical education

      Caleb Andrus-Gazyeva | Policy
    • IMGs are the future of U.S. primary care

      Adam Brandon Bondoc, MD | Physician
    • How I learned to love my unique name as a doctor

      Zoran Naumovski, MD | Physician
    • From nurse practitioner to leader in quality improvement [PODCAST]

      The Podcast by KevinMD | Podcast
  • Past 6 Months

    • Health equity in Inland Southern California requires urgent action

      Vishruth Nagam | Policy
    • How restrictive opioid policies worsen the crisis

      Kayvan Haddadan, MD | Physician
    • Why primary care needs better dermatology training

      Alex Siauw | Conditions
    • New student loan caps could shut low-income students out of medicine

      Tom Phan, MD | Physician
    • Why pain doctors face unfair scrutiny and harsh penalties in California

      Kayvan Haddadan, MD | Physician
    • Love, birds, and fries: a story of innocence and connection

      Dr. Damane Zehra | Physician
  • Recent Posts

    • How I learned to love my unique name as a doctor

      Zoran Naumovski, MD | Physician
    • My first week on night float as a medical student

      Amish Jain | Education
    • What Beauty and the Beast taught me about risk

      Jayson Greenberg, MD | Physician
    • Creating safe, authentic group experiences

      Diane W. Shannon, MD, MPH | Physician
    • The diseconomics of scale: How Indian pharma’s race to scale backfires on U.S. patients

      Adwait Chafale | Meds
    • Healing from medical training by learning to trust your body again [PODCAST]

      The Podcast by KevinMD | Podcast

MedPage Today Professional

An Everyday Health Property Medpage Today
  • Terms of Use | Disclaimer
  • Privacy Policy
  • DMCA Policy
All Content © KevinMD, LLC
Site by Outthink Group

Inhaled medications: Nefarious reasons for the lack of competition
5 comments

Comments are moderated before they are published. Please read the comment policy.

Loading Comments...