EMA wants manufacturers to offer up drug shortage 'risk analysis'
The European Medicines Agency (EMA) is offering to be the go-to authority to coordinate action in the case of some drug or device shortages in Europe caused by manufacturing problems or disruptions.
In a "reflection paper" posted on its site today, the EMA points to the hardships patients endure when they have to be switched to different drugs or medical devices when shortages arise because manufacturing plants have shut down to fix manufacturing shortcomings. It says that while it is a national problem, with a global supply chain, it can be hard for one country to address a shortage on its own. It then lays out some short- and medium-term actions it intends to take, starting with getting shortages "cataloged" to get a handle on the problem and possible fixes.
It suggests much more discussion among manufacturers, regulators and providers. It notes the need for an early notification plan for potential problems, much like the FDA now requires of drugmakers when they see that even a temporary disruption might create a drug shortage. "The industry's risk management tends to be very reactive rather than proactive. Sustained pressure is needed to bring about a change in a manufacturer's approach to quality risk management and supply chain security."
It then suggests over the medium term that it be the coordinator when problems arise to help countries decide between shutting down a plant and creating a shortage or finding an alternative to keep product flowing. Of particular interest to manufacturers may be its suggestion that they be required to submit "risk analysis" for their plants that lay out potential weak points that might fail and cause a shortage and explain how they will shore them up. The paper also says there is a need to think about having "pre-planned inclusion of failsafe manufacturing site capacity in marketing authorisations."
Under an executive order from the president, the FDA last year began requiring drugmakers to give it a heads up when they even suspected a shortage might arise. The agency then has worked more closely with manufacturers, looking for companies that can increase capacity to help fill the void. It has even permitted some similar but nonapproved drugs into the market so doctors at least have an alternative where none otherwise might exist. The FDA recently pointed out that there have been about 100 drug shortages reported so far in 2012, compared with 221 when it peaked last year, and said it's prevented 150 others. Still, one drug-tracking source says it is following 282 difficult-to-come-by drugs, showing the shortage conundrum remains serious.
- read the paper
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