Nardil shortage overview

It is likely that much of the comment here applies not just to Nardil, but also to many other less-used out of patent drugs of all kinds, not just psychotropics.  Thus, this is an illustration of the old quotation from John Donne ‘No man is an island…’.  Everyone is in this together.

This problem is likely to affect everybody everywhere, sooner or later, just like the Covid virus.

I have received information from all sorts of people all over the world and will try to condense here my deductions and thoughts about what is going on.

First, the background of changes in many aspects of laws and regulations relating to commercial activity internationally, and the production of drugs especially, have been influenced by lobbyists for the pharmaceutical industry and have influenced international treaties concerning trade.  In some instances that may make it more difficult other countries to source cheaper drugs.

Next, we have the factor of the changes in various standards and regulations relating to the production of pharmaceutical raw materials.  Some producers may not wish to make the investment necessary to accommodate to these changes — it is possible that some gamesmanship going on between the regulators and producers.

Chemicals may be formulated into medications by different companies and it can sometimes be difficult to know who is manufacturing the raw material, as opposed to who is packaging it, or distributing it.

Present information indicates that there may be just two producers of the phenelzine sulphate chemical, Lupin in India, and Kyowa Kirin in Japan.  Many sources say that the producer is X or Y, but what that really means is they are buying the raw chemical of somebody else and then making it into whatever form they sell it in — so they are really formulators and packagers, i.e. processors not ‘producers’.

Also, different Countries have different regulations about who the licensed importer is for a drug, also, which source they are licensed to imported it from.  Bureaucracy is notoriously inflexible in relation to such things.

Next, there is the difficulty of ascertaining whether companies are still producing a product, or whether they have been taken over by a different company: e.g.  Greenstone are a subsidiary of Pfizer.  It looks like such issues are relevant, particularly regarding Nardil, where (I think) Novel pharmaceuticals in New Jersey used to ‘produce’ it for North America, but were taken over by Lupin, an Indian company.  They, like Kyowa Kirin, appear to be unable to satisfy the FDA inspectors because some aspects of the production or procedures do not meet their approval standards.  Whether or not this means they have temporarily ceased producing phenelzine, or precisely why, or for how long, is difficult to ascertain.

It is probable the total world market for phenelzine is not more than $1 million.  Most new drugs measure their sales in billions, so $1m is a trivial amount.

At the end of the day what appears clear is that Nardil has been produced successfully for 50 years; furthermore, no agency has issued warnings about it, or withdrawn it, because of chemical stability or impurity issues.  But just recently the FDA appear to have decided it is somehow ‘not good enough’ and have been unable to effect the transition to a better product without causing this worldwide chaos.  To an outsider armed with the present information this would seem to be a rather unfortunate course of action that does not take adequate account of ethics and patient welfare.

It seems that none of the commercial enterprises concerned have a sufficiently keen perception of the public good to continue production when the profit is so insignificant.  It may also be that those making decisions in the major agencies like the FDA and the European EMA also have an insufficient perception of how these decisions impact patients and cause real and immediate harm, or even deaths.  Patients are caught in the middle.

I suspect the fact that it does not appear to be in short supply in the USA at the moment may be explained by the fact that USA wholesalers are much larger and probably hold more stock than other suppliers and have thus got a bigger buffer before they run out.  However, unless Lupin can restart production soon there is almost certain to be a gap where no supplies available even in the USA.  That will mean there is truly a total worldwide unavailability, possibly except for certain laboratories in China supplying it via the dark web.

I therefore conclude that the only likely remedy is that members of the American Senate and European Parliament, instruct and allow the FDA and EMA come to an accommodation with which ever manufacturers are relevant.

We at PsychoTropical continue to do what little we can and are making our best effort to provide whatever information is available, but it is important for everyone to understand that unless there is a grassroots protest it is probable that nothing will be done.  Support any petitions, and make as much noise as you can, in whatever way you can.

For some reason the relevant players, i.e. regulatory bodies, and professional organisations, do not appear to be on top of the situation.  The interests of vulnerable patients have not been safeguarded.

Donate if you can, if it was not for one substantial donation by an individual who wishes to remain anonymous, we would not be able to do what we are now doing.

Addendum re Lupin from Economic times, India times (Dated 14/6/2020)

NEW DELHI: Drug major Lupin plans to approach the US health regulator for re-inspection of its manufacturing plants in Goa, Pithampur (Madhya Pradesh) and Somerset (US) in the next few months.  The company’s Unit 2 manufacturing plant in Pithampur, along with its Goa site, is under the US Food and Drug Administration’s (USFDA) warning letter since November 2017 for violation of current goods manufacturing practices.

Read more at:
https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/plan-to-approach-usfda-for-re-inspection-of-key-plants-in-next-few-months-lupin/articleshow/76367915.cms?utm_source=contentofinterest&utm_medium=text&utm_campaign=cppst

International Supply news

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