Despite FDA having made progress in recent years to combat drug shortages, the issue is still a major problem for the agency. This very fact led to the agency requesting public comment on the subject in February 2013. Senior Vice President of Quality at Amgen, Mr Martin Van Trieste, makes some suggestions to ensure that patients continue to gain access to essential medicines.
Most drug shortages involve generic, sterile injectables; in 2011, these accounted for 73% of all reported drug shortages. In 2012, the number of shortages was less than half of what it was in 2011. There were 117 in 2012, down from 251 in 2011. Many more shortages are now also being averted. In 2011, FDA reported that it prevented 195 possible drug shortages. In 2012, 282 were prevented.
Many of these drug shortages have been blamed on the lack of reward for manufacturing quality, which is forcing manufacturers of sterile injectable generics to reduce investment into quality systems, according to FDA officials.
Some ideas from Amgen on what the pharmaceutical industry might be able to do in order to combat this trend include:
1. Learn from other industries
Leading companies in the semi-conductor, consumer electronics and automotive industries have effectively implemented simple, robust and sustainable quality systems. Getting it right the first time, with quality processes being built in from the start, will enable this to be done in a cost-effective way.
2. Introduce avoidance strategies
Using the four key elements of prevention, technology, inventory management and diversification, drug shortages can be avoided.
3. Work with regulatory authorities
Sharing ideas with FDA’s Drug Shortages Task Force is a great example of how pooling ideas can encourage high quality and facilitate the expansion of manufacturing capacity.
4. Industry collaboration
It is important to collaborate within the pharmaceutical industry when problems occur in order to enable problems to be resolved quicker and also to avoid similar problems occurring again in another company.
Unilateral FDA actions have not been able to prevent drug shortages and it is now imperative for drugmakers to contribute to solving the drug shortage problem. Companies need to make the necessary investments in quality manufacturing and work together to ensure that patients can gain access to life-saving medicines when they are needed.
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