FDA identified 20 drugs with shortage risks due to coronavirus outbreak
27 Février, 2020, 10:21 | Auteur: Yves Courtet
The outbreak highlights "severe, longstanding, and unresolved vulnerabilities in our capacity to produce life-saving pharmaceutical drugs and medical devices for our own citizens", Missouri Senator Josh Hawley wrote in a letter to the U.S. Food and Drug Administration. The FDA says it continues to monitor the global drug supply chain by prioritizing risk-based inspections in other parts of the world.
The US Food and Drug Administration (FDA) has put inspections in China on hold and warned Americans there could soon be shortages of "critical" medical products due the coronavirus outbreak.
'FDA is keenly aware that the outbreak will likely affect the medical product supply chain, including potential disruptions to suppliers [and] shortages of critical medical products in the U.S.'.
He added that these inspections have either been postponed or the FDA used 'other information to inform decisions allowing the products to enter our United States market'.
Around 88% of active pharmaceutical ingredients used in drugs for the U.S. market are manufactured overseas in 2018, with around 14% in that year produced in China, reported Reuters.
The FDA announced yesterday that it will increase its efforts to ensure the quality of "foreign products", after concerns were raised that the security of the USA drug supply chain could be compromised due to the significant amount of ingredients which are now manufactured in China.
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In response to the COVID-19 outbreak, the FDA will utilize, where appropriate, our authority to request records from firms "in advance or in lieu of" drug surveillance inspections in China. That includes certain antibiotics, generics and some branded drugs which have no alternatives, according to two sources familiar with a list complied by the US Food and Drug Administration (FDA).
According to FDA data, no inspections have been conducted of Chinese factories since December 20, 2019. By applying the use of paper records in our risk-based inspection framework, we can prioritize our early inspections on those deemed most needed, based on the records.
But the FDA reportedly said in a statement that it is "keenly aware that the outbreak could impact the medical product supply chain".
The agency says it is also now monitoring the market for anyone making fraudulent claims about preventing or curing the new virus.
We know the public may have questions or concerns for the FDA as a result of this outbreak, including you and your family's risk of exposure, or whether your critical medical products are safe and will continue to be available in the future.
The FDA has provided an update on FDA-wide activities related to the novel coronavirus outbreak: COVID-19.
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