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Safety of generics in US questioned Posted 15/11/2019

US Food and Drug Administration (FDA) regulations guarantee a safe drug supply. However, author Michael White, from the Health Outcomes, Policy, and Evidence Synthesis Group, University of Connecticut School of Pharmacy, Connecticut, USA, questions the safety of foreign generic drug imports [1].

Approximately 90% of prescribed medications in the US are generics but they only account for 26% of drug spending, saving around US$1.7 trillion over the past decade. Approximately 80% of active pharmaceutical ingredients (APIs) and 40% of finished pharmaceutical products are no longer manufactured in the US. However, Mr White says that ‘for many years, foreign manufacturers have produced substandard generic drug products and APIs and shipped them into the US’. He says that the ‘lack of quality verification of overseas generic drug manufacturing plants’ could be one of the reasons for adverse events after switching or complaints of the drug not working.

Mr White argues that ‘if the FDA had inspected them with the same rigor as they do domestic manufacturers, they would have found many of these egregious deviations from ethical manufacturing much earlier’. To do this poses a major challenge for FDA because, according to Mr White, ‘they lack the capacity to adequately oversee foreign manufacturers and struggle with international logistics’.

Examples of manufacturing issues highlighted by Mr White include that of Ranbaxy Laboratories (Ranbaxy) pleaded guilty to violations of the Food, Drug, and Cosmetic Act (FDCA) and making false statements, and agreed to pay US$500 million in civil and criminal fines to resolve the litigation [2].

In fact, Mr White points out that by 2015, 46 Indian manufacturing facilities were barred from shipping drugs to the US for one or more violations, including (1) alteration/manipulation of product and air quality data; (2) failure to review consumer complaints and hiding incident reports off site; (3) back dating quality testing; (4) altering/forging clinical trial data; (5) alteration of training records for quality assurance personnel or functions; (6) using data recording methods where data were preliminarily written down but could be overwritten, with the original data lost; (7) presence of unauthorized quality assurance stamps; and (8) performing multiple retesting of deviant samples and only recording the one that passed.

More recently, the contamination of ranitidine generics with cancer-causing agents is an issue that is affecting not just the US, but the whole world. This has led to the halt of distribution of generic versions of Zantac (ranitidine) after regulators in the US and Europe began investigating the presence of a likely human carcinogen called N-nitrosodimethylamine (NDMA) at low levels in the medications [3].

Mr White concludes that ‘generic medications are a critical component of a financially sustainable health care system’. However, he says that ‘through a history of almost non-existent quality verification of foreign drug manufacturers, the FDA allowed companies to produce poorly manufactured products and to ship them into the United States while guaranteeing physicians, pharmacists, and the US consumer that these products were interchangeable with other generic products and their brand name counterpart’. He goes on to say that ‘we run the risk of slaying the golden goose if we cannot secure our generic drug supply, and although the FDA has been making progress, their response is inadequate, and it has much left to do’.

Conflict of interest
The author of the research paper [1] did not provide any conflict of interest statement.

Related article
Ranbaxy receives another import ban from FDA

References
1. White CM. Generic drugs not as safe as FDA wants you to believe. Ann Pharmacother. 2019 Oct 15:1060028019881692. doi:10.1177/1060028019881692. [Epub ahead of print]
2. GaBI Online - Generics and Biosimilars Initiative. Ranbaxy pays US$500 million to resolve US litigation [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Nov 15]. Available from: www.gabionline.net/Generics/News/Ranbaxy-pays-US-500-million-to-resolve-US-litigation
3. GaBI Online - Generics and Biosimilars Initiative. Carcinogen contamination halts distribution of generic Zantac [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Nov 15]. Available from: www.gabionline.net/Generics/General/Carcinogen-contamination-halts-distribution-of-generic-Zantac

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