150 Drugs on Virus-related Shortage Watch List: FDA
As part of its efforts to deal with impacts from the global spread of the coronavirus, FDA has identified about 150 prescription drugs (antibiotics, generics and some brand drugs) that could be in short supply if plants in China that make the active pharmaceutical ingredients are restricted from manufacturing or distributing products, according to a 2/23 report by Axios. The virus’ continued spread across the globe rattled financial markets early Monday (2/24), including a 750-point drop in the Dow in just the first 30 minutes after opening, and finally closing down 1,032 points.
Without addressing the list directly, an FDA spokesperson reiterated agency efforts that it announced 2/14 and covered by FDA Webview here. “We are keenly aware that the outbreak will likely impact the medical product supply chain, including potential disruptions to supply or shortages of critical medical products in the U.S.,” FDA commissioner Stephen Hahn said in the earlier virus update. “We are not waiting for drug and device manufacturers to report shortages to us—we are proactively reaching out to manufacturers as part of our vigilant and forward-leaning approach to identifying potential disruptions or shortages.” Additional resources have been directed to coordinate data to better identify any potential vulnerabilities to the U.S. medical product sector, he said.
FDA has had to postpone its inspections in China due to a State Department warning against travel to the country. It currently conducts about 500 inspections per year in China. FDA said it has been in contact with global regulators and hundreds of medical product manufacturers to assess and monitor for indications and early warning signs of potential manufacturing discontinuances or interruptions due to the outbreak. “It’s worth noting that there are no vaccines, gene therapies, or blood derivatives licensed by the FDA that are manufactured in China,” Hahn said. “We are tracking reports of increased ordering of some essential medical devices through distributors, such as personal protective equipment (e.g. respirators and surgical gowns, gloves and masks).”
BioCentury reported 2/21 that Hahn is not a primary member of the HHS-driven task force that the administration has assembled to handle the coronavirus. And only two of the dozen members of the task force are physician-scientists. “HHS Secretary Alex Azar has kept tight control over official communications about the COVID-19 outbreak,” BioCentury said. “He has downplayed risks, overruling government scientists who are concerned that the virus may be spreading undetected in the U.S., according to Trump administration officials.”
Politico reported 2/21 that the White House is concerned about how a coronavirus outbreak in the U.S. could impact President Trump’s re-election chances. Three weeks ago, Trump said that U.S. officials have the coronavirus outbreak “all under control,” adding that it’s a “very small problem in this country.” His comments were made during the signing of the new North American trade deal. The president became upset with senior advisers last week after 14 Americans from a cruise ship tested positive for the virus were then flown back to the U.S. after he had been told they would remain quarantined overseas, according to The Washington Post.