FDA Approaches in Monitoring Drug Quality, Forces Impacting the Drug Quality, and Recent Alternative Strategies to Assess Quality in the US Drug Supply

Abstract

Since the US Food and Drug Administration (FDA) began monitoring the quality of pharmaceutical manufacturing by enforcing current good manufacturing practices roughly 60 years ago, forces related to the global economy have changed, rendering the task of monitoring quality more difficult. Alternative strategies by groups like Valisure, LLC, and the University of Kentucky Drug Quality Study to monitor the quality of the currently circulated US drug supply through end-product testing and screening have resulted in several concerning findings. Given the successful approaches of identifying quality defects in pharmaceuticals by non-regulatory bodies, and considering the changing landscape and pressures on manufacturing, the FDA, large buying groups, and the US Department of Defense should consider these alternative strategies as a means to augment current regulatory activities.

Spectrometric Assessment of Generic and Brand Drug Quality for a Sentinel Screening Network

“…The constant pressure to reduce drug prices can have an adverse effect on drug quality. 1 Unfortunately, there is no measure of drug quality like that which exists for drug price. There is no easy way to look up quality like there is for price.…”

“…Six decades later, after the transitions forced by the globalization of manufacturing, unexpected economic pressures, extraordinary drug shortages, and the arrival of a pandemic, self-examination by FDA regarding the best approach to monitoring quality is justified. 1 The 1906 Pure Food and Drug Act put the FDA on the path to constantly improve pharmaceuticals for patients. 2 Beginning by attacking adulteration and misbranding, the FDA moved on to the safety of drugs for use in humans and eventually required that drugs be proven effective before marketing after the 1962 Kefauver Harris Amendment to the Federal Food, Drug, and Cosmetic Act became law.…”

“…Six decades later, after the transitions forced by the globalization of manufacturing, unexpected economic pressures, extraordinary drug shortages, and the arrival of a pandemic, self-examination by FDA regarding the best approach to monitoring quality is justified. 1…”

Human health implications of emerging diseases and the current situation in India's vaccine industry

“…India's subsectors include generic pharmaceuticals, over the counter (OTC) medications, bulk drugs, vaccines, contract research and manufacture, biosimilars, and biologics. With 500 active pharmaceutical ingredients (API) manufacturers and the most Food and Drug Administration (FDA)-approved pharmaceutical production facilities, India supplies 25% of all pharmaceuticals in the UK and 40% of the demand for generics in the United States [ 13 ]. The industry accounts for 1.72% of the country's gross domestic product and is expected to reach a value of USD130 billion by 2030.…”