Inhaled medications: Nefarious reasons for the lack of competition

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.

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″.

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