For some time now, the root cause of drug shortages around the globe has been somewhat of a mystery. In fact, back in 2013, the reason for nearly half of all reported shortages was unknown.
Fast forward to 2019 and we’ve gained some well-needed clarity. Just this past October, the FDA identified that the main reasons for drug shortages are economic forces. Specifically, their top three causes for drug shortages are:
- Manufacturers tend to focus on profitable drugs due to a lack of incentives for older ones. By limiting a manufacturer’s profitability, you effectively reduce their motivation or desire to continue down a certain path. With little financial gain in pursuing older and more generic drugs, manufacturers simply will not focus on them. Unfortunately, these drugs are often the most used and critical to patient care.
- There is no focus on systems that continuously evolve and detect supply chain issues before they get out of hand. Any system that isn’t evolving will eventually fail. While all manufacturers must meet the minimum regulatory standards set forth by the Current Good Manufacturing Practices (CGMPs), there is a lack of information on how manufacturers can go beyond that… or an incentive for why they should.
- There are plenty of logistical and regulatory roadblocks that make it difficult for the market to recover after a disruption. While most other markets would respond to a shortage by increasing production, logistical and regulatory requirements limit a manufacturer’s ability to flip the switch on production. Without increased production, the increasing demand for drugs simply cannot be met.
To help combat these issues, the FDA has multiple legislative proposals and planned initiatives at work to prevent and mitigate drug shortages. These include:
- Improved data sharing and guidance
- Required risk management plans
- Incentives for adopting regulatory guidelines
In addition to the above, there’s a legislative proposal in the works to lengthen drug expiration dates. This would allow products at risk for a shortage to have the longest possible shelf life that’s scientifically justified. Currently, there are 561 batches of medication that the FDA has proposed extended use dates for.
To see the FDA’s full report on causes of drug shortages and their proposed solutions, click here.