FDA monitoring 20 drugs at risk of shortage due to coronavirus
As part of its efforts to ensure the supply of medical products from China during the ongoing coronavirus (Covid-19) outbreak, the FDA has identified 20 drugs that are made in or produced solely from active pharmaceutical ingredients (APIs) sourced from China.
In a statement to Focus, FDA spokesperson Stephanie Caccomo said the agency has been in contact with the companies that make the 20 products and that “none of these firms has reported any shortage to date.”
Caccomo also said that the FDA has been in contact with more than 180 manufacturers to remind them of their responsibility to notify the agency of anticipated supply disruptions and ask that they review their supply chains for API and other components sourced from China.
“At this time, no firm has reported a shortage is anticipated for any drug due to COVID-19,” Caccomo said.
The statement came after a report from Axios on Sunday alleged that FDA had compiled a list of about 150 drugs that are at risk of shortage, which prompted Sen. Josh Hawley (R-MO) to send a letter to the FDA.
While the number of products FDA is monitoring seems to be low, concerns are still being raised about the US’ reliance on China for pharmaceuticals and other medical products.
In a letter sent to FDA on Tuesday, Rep. Bill Pascrell (D-NJ) and Sen. Robert Menendez (D-NJ) said the outbreak poses a “potentially calamitous” risk to the US medical product supply chain. The lawmakers asked the FDA for more details on how it plans to ensure the safety and security of drugs and personal protective equipment sourced from China.
Meanwhile, on Tuesday, the World Health Organization brought its tally of confirmed cases of the virus to more than 80,000 globally, including 2,700 deaths. While the number of new cases reported in China seems to have plateaued, the situation remains volatile as more countries report cases.
The US Centers for Disease Control and Prevention (CDC) also warned that it expects the coronavirus to eventually become more widespread in the US. So far, the CDC has confirmed 57 cases of Covid-19 in the US, 40 of which were evacuated from the Diamond Princess cruise ship that was quarantined in Japan.
During a telebriefing on Tuesday, Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Diseases, said, “Ultimately, we expect to see community spread in this country. It’s not so much a question of if this will happen anymore but rather a question of when this will happen and how many people in this country will have severe illness.”
RAPS: First published in Regulatory Focus™ by the Regulatory Affairs Professionals Society, the largest global organization of and for those involved with the regulation of healthcare products. Click here for more information.