FDA responds to potential drug shortages by taking actions to address their underlying causes and to enhance product availability. FDA determines how best to address each shortage situation based on its cause and the public health risk associated with the shortage.
For manufacturing/quality problems, FDA works with the firm to address the issues. Problems may involve very low risk (e.g. wrong expiration date on package) to high risk (particulate in product or sterility issues). Regulatory discretion may be employed to address shortages to mitigate any significant risk to patients.
FDA also works with other firms making the drugs that are in shortage to help them ramp up production if they are willing to do so. Often they need new production lines approved or need new raw material sources approved to help increase supplies. FDA can and does expedite review of these to help resolve shortages of medically necessary drugs. FDA can’t require the other firms to increase production.
When a shortage occurs and a firm has inventory that is close to expiry or already expired, if the company has data to support extension of the expiration dating for that inventory, FDA is able to review this and approve the extended dating to help increase supplies until new production is available.
When the US manufacturers are not able to resolve a shortage immediately and the shortage involves a critical drug needed for US patients, FDA may look for a firm that is willing and able to redirect product into the U.S. market to address a shortage. FDA considers a list of criteria to evaluate the product to ensure efficacy and safety. These criteria include the formulation and other attributes of the drug as well as the quality of the manufacturing site where the drug is made.
FDA works to find ways to mitigate drugs shortages; however, there are a number of factors that can cause or contribute to drugs shortages that are outside of the control of FDA.
Also, FDA issued a long-term strategic plan to outline the agency’s priority actions, as well as actions drug manufacturers and others can take, to prevent drug shortages by promoting and sustaining quality manufacturing.
