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Emergency actions to protect patients and the drug supply may have long-term implications.
The rapid spread of the novel coronavirus, COVID-19, in China and beyond prompted the World Health Organization to declare a Public Health Emergency of International Concern on Jan. 30, 2020, and pushed regulatory organizations to evaluate needed response, researchers to accelerate studies of potential treatments and vaccines, and pharma companies to examine supply chain and business disruptions. For an industry accustomed to long development and approval times, stringent regulatory oversight, and a not-so-transparent supply chain, the coming months may test bio/pharma’s ability to react, adapt, and change.
In a February 2020 report, FDA’s Office of Pharmaceutical Quality (1), noted that, “Quite simply, the quality of our drug supply is better than ever before.” That same report, however, noted that nearly half of the physicians responding to a 2019 survey said drugs manufactured abroad were of lower quality than those manufactured in the United States. In light of the volume of APIs manufactured offshore, consumer confidence in drug quality may further erode with FDA’s suspension of facility inspections in China, in accordance with a US State Department warning against travel in the region.
The agency said its regular risk-based surveillance testing of imported products will continue, however. In lieu of inspections, the agency will use alternate measures, include import screening, import alerts, a firm’s previous compliance history, and information from foreign governments as part of mutual recognition agreements. The agency said it also will request records from firms “in advance or in lieu of” drug surveillance inspections in China to assess possible quality threats (2).
A number of pharma companies and organizations are accelerating the investigation of treatments and vaccines. For example, in late February, the National Institute of Allergy and Infectious Diseases initiated the first US clinical trial to evaluate the safety and efficacy of remdesivir (Gilead Sciences), on a volunteer patient diagnosed with COVID-19 who was quarantined on a cruise ship in Japan and repatriated to the United States. The investigational broad-spectrum antiviral treatment was previously tested in humans with Ebola virus disease and has shown promise in animal models for treating other coronaviruses (3).
FDA stated that the agency is providing regulatory advice, guidance, and technical assistance to sponsors developing medical countermeasures to emerging threats. These efforts include the review of development proposals including the design and set-up of clinical trials. The agency also noted that under Emergency Use Authorization authority, the agency may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency when clinical circumstances warrant (2).
As US manufacturers rely on manufacturers in China for a significant portion of APIs and other raw materials, the potential for supply disruptions and drug shortages is likely. FDA noted that the agency is “proactively reaching out to manufacturers as part of our vigilant and forward-leaning approach to identifying potential disruptions or shortages” and is adding resources to monitor potential vulnerabilities. In the event of a potential shortage or disruption, FDA says it will work with manufacturers to expedite review of alternate supplies to prevent shortages (2).
Whether a disruption in the raw materials supply chain is incentive for US-based manufacturers to seek alternate suppliers in the West will be just one factor to watch.
1. FDA, “Office of Pharmaceutical Quality, 2019 Annual Report, One Quality Voice,” www.fda.gov, February 2020.
2. FDA, Novel Coronavirus (COVID-19), www.fda.gov, accessed Feb. 26, 2020.
3. NIH, “NIH Clinical Trial of Remdesivir to Treat COVID-19 Begins,” Press Release, Feb. 25, 2020.
Vol. 33, No. 3
When referring to this article, please cite it as: R. Peters, “Coronavirus Response: Reaction or New Reality?,” BioPharm International, 33 (3) 2020.