Faulty Abbott Glucose Monitors Linked to Fatalities

Abbott Laboratories is a global healthcare company founded in 1888 by Dr. Wallace Abbott, a practicing physician and drugstore owner in Chicago. Initially named Abbott Alkaloidal Company, it pioneered the formulation of "dosimetric granules," standardized doses of active medicinal alkaloids, improving drug consistency and effectiveness. Over more than 130 years, Abbott has evolved into a diversified leader in medical devices, diagnostics, nutrition, and branded generic pharmaceuticals, employing around 113,000 people across over 160 countries with headquarters still in Chicago[1][2][3]. Abbott’s historical milestones include early international expansion in 1907 with an office in London and significant product innovations such as the first synthetic medicine Chlorazene in 1916, the introduction of Pentothal in 1935, and the development of blood chemistry analyzers in the 1970s. Abbott played a critical role during World War I and II by producing essential drugs like penicillin. The company has continuously expanded through acquisitions, notably purchasing St. Jude Medical and Alere Inc. in 2017 for over $28 billion, significantly boosting its cardiovascular and diagnostics portfolios[1][2][3][9]. Key achievements include FDA approvals of breakthrough products such as Humira (2002), glucose monitoring systems like FreeStyle Libre (2014), and recent innovations in cardiac devices like the Aveir DR approved in 2023. Abbott also responded rapidly to the COVID-19 pandemic by launching multiple diagnostic tests. It has maintained leadership in diabetes care, cardiovascular health, and laboratory diagnostics while expanding nutritional products like Similac and Ensure under its brand umbrella[1][2][5][6][8]. Currently led by CEO Robert B. Ford, Abbott continues to leverage science and innovation to improve global health outcomes. It is recognized for adapting swiftly to technological advances and shifting healthcare needs, holding a strong position in the competitive healthcare market with a commitment to accessible, high-quality medical solutions worldwide[2]

The **U.S. Food and Drug Administration (FDA)** is a federal agency responsible for protecting public health by regulating food, drugs, medical devices, cosmetics, tobacco, and veterinary products in the United States. Its core mission is to ensure the safety, efficacy, and security of these products through rigorous oversight, scientific evaluation, and enforcement of federal laws, notably the Federal Food, Drug, and Cosmetic Act (FD&C Act) signed into law in 1938[2][5][9]. The FDA's history dates back to the early 20th century with the 1906 Pure Food and Drugs Act, but its modern regulatory authority was significantly shaped by the 1938 FD&C Act, which required pre-market safety review of drugs and banned false therapeutic claims[2][5]. Key legislative milestones include the 1951 Durham-Humphrey Amendment, which defined prescription drugs, and the landmark 1962 Kefauver-Harris Amendments that mandated proof of both safety and efficacy before drugs could be marketed, marking the start of the FDA's modern drug approval process[2][6]. The agency's role expanded over time to include regulation of cosmetics, medical devices, biological products, and tobacco[5]. The 1997 FDA Modernization Act further refined regulations, improving patient access to experimental treatments and speeding review processes[3]. Notable achievements include preventing the approval of thalidomide in the U.S., which averted widespread birth defects seen elsewhere, and establishing stringent drug approval standards that make the U.S. regulatory system one of the toughest globally[2][6]. The FDA also enforces labeling laws for consumer products and has pioneered initiatives such as the Office of Prescription Drug Promotion to ensure truthful drug advertising[3]. Today, the FDA remains a critical player at the intersection of business, science, and technology, balancing innovation with public safety. It faces ongoing challenges from emerging technologies, complex product innovations, and global supply chains but continues to adapt its regulatory framework t