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FDA Combats Drug Shortages

Expert identifies ways to mitigate shortfalls

Approximately 70 medications are in short supply age in the U.S., according to Cynthia Schnedar, Director of the Office of Compliance for the FDA’s Center for Drug Evaluation and Research. She said the agency is urging manufacturers to increase production. Schnedar informed suppliers and group-purchasing executives about the agency’s efforts at the 2015 Healthcare Supply Chain Expo.

As reported by Modern Healthcare, approximately 37% of drug shortages are due to factory issues, Schnedar said, and the two other biggest reasons are difficulties accessing raw materials, and manufacturing delays or capacity issues. Some shortages are resolved over the calendar year. Shortages of sterile injectables—which include antibiotics, cancer medications, and anesthetics—are often related to issues with sterility, bacterial or fungal contamination, visible particulates in the medication, or crystallization. 

Schnedar said there is no simple fix for the shortages because the manufacturing processes and chemical makeup of drugs is so complex, and because the root causes of shortages often affect multiple products at once. In addition, manufacturers doesn’t necessarily have an incentive to ramp up production if they're not likely to make a profit.

There are a number of things that the FDA can do to help manufacturers avoid or resolve shortages, Schnedar said, including allowing the manufacture of medically necessary products with additional safety controls. The agency can also request other firms to increase their production of a product if it's made by multiple companies; expedite reviews for new manufacturing sites or changes to product information; or even allow temporary importation from otherwise unapproved sources (in rare cases), she said. 

Source: Modern Healthcare, October 6, 2015.

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