US and EU industry issue response to coronavirus
According to the latest data released by the World Health Organization, a total of 80,239 are confirmed to be infected by the novel coronavirus, an outbreak of which was first reported in Wuhan, China, on December 31, 2019.
Out of the confirmed cases, 2,666 (<3.5%) of patients in China have lost their life, while the reported deaths outside of China are 34, out of 2,459 confirmed cases (1.38%).
European reaction
In a recent announcement, the European Medicines Association (EMA) informed the public that it has activated its plan for managing emerging health threats, and that it is analyzing ‘all available information’ on developers’ drug pipelines with potential to help tackle the disease.
The agency also called for developers working on medicinal products that could be used for treatment or prevention to contact the agency. The agency’s support measures include scientific advice, the PRIME scheme, accelerated assessment, and conditional marketing authorization procedures.
On the industry’s side, the European Federation of Pharmaceutical Industries and Associations (EFPIA) outlined in an announcement on Tuesday its members’ efforts to fight the virus and stated that, as the situation evolves, member companies will “prioritize the continuity of their supply chains and are working proactively to prevent and mitigate any potential shortages through close coordination with the EMA and other global stakeholders.”
“At this stage, manufacturers have not reported any shortages or delays in production,” the organization added.
US response
On the other side of the Atlantic, where the number of confirmed cases to date is 53, with no reported deaths, both regulators and industry representatives broadcast their efforts on addressing the outbreak.
In an announcement on Monday, which followed an initial release on February 14, the US Food and Drug Administration (FDA) stated its actions include focusing on facilitating diagnose; treating and preventing the disease; surveilling the medical product supply chain for potential shortages or disruptions; and stopping fraudulent activity that would take advantage of worried populations.
In order to protect the integrity of the supply chain, and monitor products incoming from China, the FDA said it will utilize its “authority to request records from firms ‘in advance or in lieu of’ drug surveillance inspections in China.”
This means that the agency can request distributors and manufacturers records from on-site drug inspections ahead of time, taking a ‘more risk-based’ approach to conducting both domestic and foreign inspections.
Moreover, the agency noted that it intends to ‘aggressively’ monitor the market for any firms marketing products with fraudulent COVID-19 prevention and treatment claims.
“The FDA can and will use every authority at our disposal to protect consumers from bad actors who would take advantage of a crisis to deceive the public, including pursuing warning letters, seizures, or injunctions against products on the market that are not in compliance with the law, or against firms or individuals who violate the law,” the agency noted.
On the industry’s side, the Pharmaceutical Research and Manufacturers of America (PhRMA), released an announcement February 11, in which it stated that its members devote their “expertise, resources and capabilities to identify science-based solutions and medical treatments to combat this threat,” citing that further details are soon to be announced.
