FDA reports first drug shortage due to novel coronavirus outbreak


(NEW YORK) — The U.S. Food and Drug Administration announced it’s been alerted to the first manufacturing shortage of an unnamed drug, due to a viral coronavirus outbreak that began in China and has now reached American soil.FDA Commissioner Stephen Hahn said the agency has been “closely monitoring” the medical product supply chain “with the expectation” that the outbreak of the novel coronavirus would “likely” have an impact. “A manufacturer has alerted us to a shortage of a human drug that was recently added to the drug shortages list,” Hahn said in a statement Thursday night. “The manufacturer just notified us that this shortage is related to a site affected by coronavirus. The shortage is due to an issue with manufacturing of an active pharmaceutical ingredient used in the drug.””It is important to note that there are other alternatives that can be used by patients,” he added. “We are working with the manufacturer as well as other manufacturers to mitigate the shortage. We will do everything possible to mitigate the shortage.”Hahn said the issue continues to be “an evolving and very dynamic” one.The newly identified virus, known officially as COVID-19, emerged in the Chinese city of Wuhan back in December and has since spread overseas to at least 46 other nations, with South Korea, Italy and Iran seeing recent surges in case numbers. The World Health Organization, which has declared the outbreak a global health emergency and said the virus has “pandemic potential,” recorded more than 82,000 confirmed infections globally by Thursday. More than 95% of those cases were in China.At least 2,804 people have died from confirmed cases of the virus, all but 57 in China, according to the latest data from the WHO.So far in the United States, 60 people have been diagnosed with the disease. The majority of the cases are Americans who were on board the Diamond Princess cruise ship that was placed under quarantine in Japanese waters as hundreds of passengers became infected with the new coronavirus.The newest case is being investigated by the U.S. Centers for Disease Control and Prevention as possibly the first instance of “community spread” on American soil.The patient, who is a resident of California’s Solano County, had no known exposure to the virus through travel or close contact with a known infected individual, according to the California Department of Public Health. The individual was transferred to UC Davis Medical Center in Sacramento on Wednesday, the hospital confirmed.It’s the first COVID-19 case of unknown origin in the U.S., indicating there could be “community spread,” which means the virus is circulating among the local community and infecting people, including some who are not sure how or where they became infected, according to the CDC.The CDC said it would continue to investigate the source of the infection. It’s “possible” that the individual “may have been exposed to a returned traveler who was infected,” an agency official said in a statement Wednesday.COVID-19 causes symptoms similar to pneumonia, ranging from the mild, such as a slight cough, to the more severe, including fever and difficulty breathing, according to the CDC. There is no vaccine yet for the virus.The FDA said Thursday that it is “not aware of any reports at this time of human illnesses that suggest COVID-19 can be transmitted by food or food packaging.”Meanwhile, a whistleblower within the U.S. Department of Health and Human Services has filed a complaint alleging that more than a dozen workers were sent to receive the first Americans repatriated from Wuhan, China, without proper training or protective gear for coronavirus infection control. The complaint, filed to the U.S. Office of Special Counsel, was first reported by The Washington Post on Thursday.ABC News has not reviewed the complaint, and lawyers representing the whistleblower have refused to provide it. However, Ari Wilkenfeld, one of the whistleblower’s attorneys, told ABC News that the article by The Washington Post accurately describes the allegations laid out in the complaint.

“We are hopeful that Congress and the OSC will investigate this case in a timely and comprehensive manner,” Wilkenfeld told ABC News in a statement. “This matter concerns HHS’s response to the coronavirus, and its failure to protect its employees and potentially the public. The retaliatory efforts to intimidate and silence our client must be opposed.”Moreover, a spokesperson for the U.S. Office of Special Counsel confirmed to ABC News that they have received the whistleblower’s complaint as described in The Washington Post, and that the case has been assigned.When asked for comment, U.S. Department of Health and Human Services spokesperson Caitlin Oakley told ABC News: “We take all whistleblower complaints very seriously and are providing the complainant all appropriate protections under the Whistleblower Protection Act. We are evaluating the complaint and have nothing further to add at this time.” Copyright © 2020, ABC Audio. All rights reserved.

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