Drug shortages can occur for many reasons, such as 1) manufacturers being unable to obtain raw materials, 2) drug makers having manufacturing problems which result in safety risks for patients and not able to produce more product until the issues are corrected, and 3) business decisions being made by a company to discontinue a drug.
FDA established the Drug Shortage Program to help address shortages of over-the- counter and prescription medications. The ways that FDA can address shortages are:
- Working with firms to resolve manufacturing issues to allow medications to return to the market.
- Speeding up FDA’s review process so that new manufacturers interested in making drugs in shortage can supply their products as soon as possible.
- Helping firms with getting new sources of raw material.
When firms decide to discontinue making a drug, this is often due to business reasons. It is important to know that FDA is not able to force a company to continue making a medication. If a product is medically necessary and a shortage will occur due to a company’s decision to discontinue a medication, FDA can look for alternate manufacturers and work with the alternate manufacturers to bring the product back to the market.
To inquire about a drug’s availability or to report a shortage to FDA, please use the e-mail account firstname.lastname@example.org
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