WRITE TO THE THERAPEUTIC GOODS ADMINISTRATION

Copy and paste the sample letter below and email it to medicine.shortages@health.gov.au:

Hands on Deck
 
 

I am writing in relation to the addition of the EpiPen adrenaline (epinephrine) 0.3mL injector syringe auto-injector and the EpiPen JR adrenaline (epinephrine) 0.15mL injection syringe auto-injector to the Medicine Shortages Information Initiative Register on 5 March 2020.


My family is impacted by allergies and relies heavily on the availability of a reliable, unexpired auto-injector product.


We are becoming increasingly concerned regarding the Government’s inaction in addressing the ongoing shortages of this lifesaving medication.   It is unacceptable that we only have access to one product – EpiPen and EpiPen Jr, when there are additional options available internationally.


Whilst we would prefer to have access to an alternative adrenaline auto-injector product on a permanent basis we appreciate that this may be difficult to arrange in a timely way given the shortage is already upon us. Under the circumstances, it is apparent that now is the time for the TGA to utilise its powers pursuant to Section 19A of the Therapeutic Goods Act 1989.  I call on the TGA to facilitate the availability of unregistered medicines for the duration of this shortage and any future shortages which may occur.


Regardless of whether a shortage is short or long, no period of interruption to supply of this product is acceptable.  Mylan have provided assurances regarding supply of their products in the past however they continue to have difficulties in their manufacturing processes.  Under the circumstances it is essential that the TGA move to immediately have an alternative product available ready to access when needed.  


To this end I note the following contingency plans have been made in other countries: 


The United States has a generic form of the EpiPen product manufactured by Teva Pharma.  Teva Pharmaceuticals have a commercial presence in Australia and, given the product is exactly the same as the EpiPen, it would appear to be the most attractive alternative.  https://www.tevaepinephrine.com


In Canada the Government moved to gain access to Auvi-Q auto injectors in instances where the EpiPen products were not available.  https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2018/67658a-eng.php


The British Government also has contingency arrangements for instances where there are shortages.  They have three approved products including the Jext auto injector.  https://psnc.org.uk/wp-content/uploads/2019/08/SDA.2019.004-Emerade-Final-1.pdf


I urge you to do all that you can to facilitate the introduction of an alternative device.  I fear, as a person impacted by severe allergies, that someone may be caught in a situation where they did not have access to this lifesaving medication because of these shortages.  This would be unforgivable given that it is within the power of the regulators to do something about it.


I look forward to hearing from you.

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