FDA reports first drug shortage due to coronavirus outbreak
In an announcement made on Friday, the US Food and Drug Administration (FDA) said that it was alerted by a manufacturer regarding the shortage of an undisclosed drug product. However, the agency noted that alternative products are available.
According to the agency, the shortage is related to ‘issues’ with the manufacture of an active pharmaceutical ingredient (API) at a site affected by the coronavirus, and the product was added to its drug shortages list.
FDA commissioner, Stephen Hahn, said the FDA expects the outbreak to impact the medical product supply chain, including potential disruptions to supply or shortages of critical medical products in the US.
According to the World Health Organization, China accounts for the largest share of the global active pharmaceutical ingredients (APIs) market by volume.
Industry analysis already claimed that the supply of APIs will face disruption due to manufacturers suspending operations at their facilities located in affected areas.
Further to the first drug shortage, the agency also confirmed that it has been in touch with more than 180 manufacturers, calling on them to evaluate their supply chains, including APIs, that have links with China.
In addition, the agency has identified 20 drug products which solely source their APIs or finished products from China and contacted their manufacturers, which reported no shortages to date.
Requests for additional authority
The FDA also announced that it has submitted four proposals to US congress, which are expected to ‘better equip’ the regulatory body to prevent or mitigate medical product shortages.
These proposals include lengthening of drug’s ‘unnecessarily short’ expiration dates, with the agency stating that by expanding its authority to “require ... that an applicant evaluate, submit studies to the FDA, and label a product with the longest possible expiration date that the FDA agrees is scientifically justified, there could be more supply available to alleviate the drug shortage or the severity of a shortage.”
The second request regards the ability of the agency to require application holders of certain drugs to conduct periodic risk assessments to identify the vulnerabilities in their supply chain, since currently many manufacturers ‘lack plans’ to assess and address these vulnerabilities, according to the FDA.
Another proposal to Congress could see the FDA strengthen its data requirements, by asking additional and more detailed information during its assessments of manufacturers’ infrastructure.
Finally, the agency asked Congress to provide it with extended authority to also examine the supply chain of medical devices, manufacturers of which are not currently obliged to notify of any shortages.
