Drug Shortages: We know it can be frustrating when you can’t get a medicine you need. That’s why FDA works closely with the pharmaceutical industry and stakeholders to prevent drug shortages and to lessen the impact on patients anytime there is a delay in the availability of the medicines you need. Ensuring there are as few disruptions to patient care as possible is one of our top priorities.
- Several factors, that are outside of our control, can cause or contribute to drug shortages. Sometimes manufacturers have an unforeseen breakdown in manufacturing lines affecting their production. Other times, shortages are caused by product quality problems, a manufacturer discontinuing a product, or unexpected surges in demand brought on by things like seasonal illnesses.
- In many instances, companies can eventually meet the demand allowing consumers to get the medicines they need.
How FDA helps prevent and resolve shortages
- Expedite reviews of new production lines or material sources to increase production quickly,
- Extend product expiration dates, if it is safe to do that,
- Import medicines to the U.S., if they meet our safety and effectiveness criteria.
FDA cannot require a pharmaceutical company to:
- Make a drug, even if it is a medically necessary drug,
- Make more of a drug,
- Change how much and to whom the drug is distributed.
How the pharmaceutical industry can help prevent drug shortages
Drug companies must notify FDA about manufacturing interruptions or product discontinuances and create a risk management plan for their product supply chain. Early notification from drug companies of any issue that could lead to a potential disruption in supply is critical to preventing or lessening the impact of drug shortages.
For more information visit FDA Drug Shortages.