Persistent drug shortages in 2023

And NMN ban by the FDA.

For a good few years now, I have been covering the cascade effects of all decisions made in 2020, this Substack I have covered many of the dynamics, and while it has been a while since I published Beyond Mathematical Odds, I think it is time to go back into that type of analysis, I gave my readers mind enough time (vulgarly referred to as timeline cleanser). But today’s topic is merely a fraction of it, although an important one.

The growing drug shortage

As I wrote and subtly warned a few times in the last 2 months, some of the dynamics changed, but the end results stayed the same.

Here's why some countries are experiencing medicine shortages – and what can be done to ensure supply

Europe, for instance, is experiencing shortages of common medicines. In a survey of medicine shortages carried out between 14 November and 31 December 2022 by the Pharmaceutical Group of the European Union (EU), 100% of the 29 member countries reported experiencing shortages of medicines among community pharmacists and 76% said that shortages were worse than the previous year, 2021. About 79% of respondents reported shortages of anti-infectives for systemic use; while 76% found it difficult to get hold of drugs for respiratory problems; and a range of other conditions, including cardiovascular and gastrointestinal were also highlighted.

But medicine shortages are not unique to the EU region. The UK is experiencing an HRT shortage. US hospitals are reporting supply problems with liquid ibuprofen; while a sudden increase in ADHD diagnoses in the US has led to an unexpected shortage in the drugs used to treat it there. In Mexico, chronic medicine shortages are so dire that many prescriptions couldn’t be fulfilled in 2022, while across Asia, sudden supply drops were linked to disruptions in China and in Australia, the TGA has confirmed various shortages have been seen, and rural areas may be worst affected.

In the end, the article itself gives a short but rather good answer to why exactly these shortages persist.

Meanwhile, the war in Ukraine continues to impact supply chains and the knock-on effect of high inflation and energy prices have hit generic drug manufacturers, who are sometimes subjected to pricing regulations, particularly hard.

Furthermore, to protect their limited medicine supplies, some countries have temporarily blocked the parallel trade of medicines to other countries. And, once an over-the-counter drug shortage is announced on the news, consumers begin stockpiling.

Why Europe's drug shortages may get worse

• Most European countries reporting shortages of antibiotics

• Low generic drug prices mean razor-thin margins for firms

• Companies say they cannot boost output enough due to costs

• Some say making generics in Europe becoming unsustainable

While the explanation for the global drug shortage is many, starting with 2020’s lockdowns, the increase in energy prices and resource nationalism, Europe’s situation is worse not solely because of the war in Ukraine, or any of the aforementioned reasons. Regulatory inefficiency and the incapacity of bureaucrats to think even just months ahead, let alone second and third-order effects.

It isn’t exactly new, between pharmacists and drug manufacturers it is talked about how they take too long and are too slow to adapt then you add salt to injury with government stupidity and you get ever-growing shortages.

While many countries around the world have reported shortages of antibiotics as respiratory infections return with a vengeance after the lifting of pandemic restrictions, the problem in Europe is particularly acute.

With prices for generics regulated, many European drugmakers said they are reluctant to expand capacity at a time when the war in Ukraine has pushed up the cost of everything from energy for factories to cardboard for packaging to aluminium for bottle caps - suggesting more shortages are on the cards.

According to 13 European manufacturers and six generic drug industry associations and trade groups who spoke with Reuters, many firms are struggling to make enough money to justify making antibiotics at all - let alone increase production.

With everything that happened in the last 3 years, there is no reason for most generic manufacturers to expand production, there is little spare capacity, and literally no financial incentive to do so, regulatory measures making any producer unable to adapt to quickly increasing costs all over the board.

UK pharmacists are now sounding the alarm on the shortages, and many of the producers are warning shortages will persist at the very least for the entire year and might even get worse. Similar to the reason other countries are experiencing shortages (EMA regulatory demands), the NHS has a cap on how much it will pay for drugs, but input, energy, and total production costs all increased substantially.

This is where the second and third-order effects come in, the first thing everyone involved in the use of drugs to treat any type of medical condition does when faced with a shortage is to recommend a substitute. But as anyone who reads this substack or many others, or uses social media is aware the number of people getting sick (and sicker) is substantial, in fact increasing every quarter leading to subsequent shortages of substitute drugs thus creating a negative feedback loop. Belgium is even in a worst position, facing a shortage of over 1.000 (thousand) drugs, quite enlighting when the data comes from… reliable sources too.

Belgium is currently facing a serious drug shortage with a total of 1,239 medicines being unavailable – a far cry from numbers revealed by the country’s Federal Medicines Agency – according to the  Febelco Group, Belgium’s biggest medicines supplier, Belgian media reported.

The number of drugs in short supply is higher than what was announced by PharmaStatut, an initiative of the Federal Agency for Medicines and Health Products (FAMPH), which estimates 363 medicines were unavailable over the last 30 days,  Het Nieuwsblad, De Standaard and Het Belang van Limburg reported Tuesday.

Taking into account medicines that have been unavailable for some time, this number reaches 1,239, according to Febelco, Belgian media reported.

In an open letter to pharmacists, Febelco CEO Olivier Delaere says he is “concerned about the situation [drug shortage], but also about the way it is communicated [by the Federal authorities]”.

“In our view, PharmaStatut does not provide an accurate picture of the unavailability of medicines,” he continued.

How many other countries are experiencing the same, where government corruption and malfeasance attempt to hide their poor management of every single facet of public health, taking longer for the public itself to find out that at the core of the problem, things are actually worse ? \

Given the current dynamics at play, where basically very few things changed, the upward pressure on energy prices will persist for a while (months if nothing else goes wrong), green tech failing to fill the gap, my advice in the drug shortage piece mentioned above is still as valid or even more right now.

If you use or need or want to stock some drugs as a “break glass in case of emergency”, I highly advise you to do so if you didn’t already. Drug shortages will persist for most of the globe, and I expect that perhaps some might even get worse from both the production and demand side since there are just too many immune systems mildly depressed right now, among unforeseen…consequences and events.

And as a matter of PSA (Public Service Announcement), the proposed FDA ban on NMN (Nicotinamide Mononucleotide), a supplement I suggested quite a few number of people take in the place of Niacin (Flush type), and quite powerful in many people afflicted by Long Covid, was “approved”.

Amazon bans NMN in dietary supplements

Amazon has advised sellers of NMN they can no longer sell the anti-aging ingredient as a dietary supplement, following an FDA determination last year, Natural Products Insider learned Thursday.

In an email to an NMN brand that Natural Products Association (NPA) President and CEO Dan Fabricant forwarded, Amazon cited an FDA decision “that NMN is no longer considered a dietary supplement” but rather is deemed “a drug, or drug ingredient, that requires FDA approval.”

“Products that contain NMN as an ingredient can no longer be sold or distributed as a dietary supplement by manufacturers or retailers in the United States,” the email from Amazon Services stated. “If you want to sell NMN on Amazon, you must show that you are approved by the FDA for over-the-counter sales.”

In the email, Amazon said the seller could continue to offer NMN-containing products until March 13, 2023. After that date, the merchant would need to meet certain requirements, including uploading labeling with the National Drug Code, which is an FDA directory about finished drug products, unfinished drugs and compounded drug product.

However, Fabricant described FDA’s “behavior” as “inexcusable." He said his trade group “will use every available resource to ensure the agency is again accountable to consumers and the industry, just like we did with NAC.”

“This is just yet another instance where the FDA’s interpretation of the law is not only wrong but has caused confusion and significant economic harm,” he concluded.

As with NAC, supply will dwindle for a while, so if you want to secure some NMN now would be the time. And for the information of any layperson, you can take NR (Nicotinamide Riboside) in the place of NMN, or do it like me and other people do, taking Niacin Flush-type (with food to minimize the flush, quite a little bit of food and fiber actually).

Grateful for the people who choose to support this endeavor and anyone who shares it. This would not possible without you.