Eye Drop Quality Issues: Can the FDA See This One Through?

Author:

White Lyla R.1,White C. Michael1ORCID

Affiliation:

1. School of Pharmacy, University of Connecticut, Storrs, CT, USA

Abstract

The Food and Drug Administration (FDA) has long suffered from a lack of resources limiting their inspection capacity. They have fallen behind on proactive surveillance inspections of foreign manufacturing sites, relying instead on for-cause inspections after a problem has been discovered. Over-the-counter (OTC) products are especially vulnerable because the FDA considers them lower priority. This issue recently made big news after improperly manufactured OTC eye drops harmed users across the country, in some cases causing blindness. To prevent future harm to Americans, it is imperative that the FDA receives enough resources to keep up with their routine inspections.

Publisher

SAGE Publications

Reference24 articles.

1. Office of Inspector General. The Food and Drug Administration’s foreign for-cause drug inspection program can be improved to protect the nation’s drug supply. Accessed December 18, 2023. https://oig.hhs.gov/oas/reports/region1/11901500.asp

2. United States Government Accountability Office. FDA should take additional steps to improve its foreign inspection program. Accessed December 18, 2023. https://www.gao.gov/assets/gao-22-103611.pdf

3. Oestreich L, Giaquinto M, Auchincloss K. Trends in FDA FY2022 inspection-based warning letters. Accessed December 18, 2023. https://www.outsourcedpharma.com/doc/trends-in-fda-fy-inspection-based-warning-letters-0001

4. OMUFA II Ratifiers Steering Committee Meeting. OMUFA reauthorization: introductory public meeting. Accessed December 18, 2023. https://www.fda.gov/media/172798/download

5. U.S. Food and Drug Administration. OTC warning letters. Accessed December 18, 2023. https://www.fda.gov/drugs/enforcement-activities-fda/otc-warning-letters#ophthalmics

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