Unhappiness about persistent drug shortages is becoming more acute, both in Europe and the US. Hospitals in The Netherlands are routinely short of around 40 products, whereas in the US 180 medications have now made it onto FDA’s list of scarce products. Hospital pharmacists spend an increasingly large amount of time trying to source scarce items and, despite their best efforts, doctors and patients are increasingly noticing the scarcities.
Calls to action are being made. Last year the American Society of Health-System Pharmacists arranged a meeting with FDA and other bodies, but the shortages have got worse since then. After all, article 81 of Directive 2011/83/EC of the European Parliament states that it is illegal for holders of a marketing authorisation not to supply licensed products and that they have a responsibility to cover the needs of patients. Tightening up the legislation is also being considered in the US.
There, a group of leading oncologists has even started a non-profit drug company that it hopes will soon be able to import supplies of some of the missing medicines. The company will eventually manufacture the drugs itself, according to Dr George Tidmarsh, a paediatric oncologist and biotechnology entrepreneur who was interviewed by The New York Times [1].
Many factors contribute to the problems. However, a common perception is that the Big Pharma cannot be bothered to maintain investment in low-profit older drugs. Another part of the problem is today’s worldwide supply chain. The standards expected in Europe and the US are gradually expanding to companies in poorer countries but many will try to find short cuts in a slow process, also for financial reasons.
Editor’s Comment
Does the main problem lie with Big Pharma? Or are we trying to push the standards for medicines manufacturing to unrealistically high levels? In the end, are today’s standards justified in a world in financial turmoil? As yet, the question is unthinkable.
Please feel free to share your thoughts via email to editorial@gabionline.net or in the comments section below. What do you think are the reasons for drug shortages? Who is really to blame? How can the generics/biosimilars industry help to alleviate these shortages?
Related articles
US drug shortages – FDA may hinder, but APP may help
Record high drug shortages in the US
US drug shortages – frustration and safety concerns
Reference
1. GaBI Online - Generics and Biosimilars Initiative. US drug shortages prompt oncologists to go into drug manufacture [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2011 October 28]. Available from: www.gabionline.net/Generics/News/US-drug-shortages-prompt-oncologists-to-go-into-drug-manufacture
Source: FDA, HealthDay, New York Times
0
Post your comment