As a public service, The Inquirer is making this article and other critical public health and safety coverage of the coronavirus available to all readers.
The U.S. Food and Drug Administration is being criticized for announcing the first drug shortage caused by China’s coronavirus epidemic — without disclosing the name or maker of the drug.
The Feb. 27 news release by FDA Commissioner Stephen M. Hahn, the former head of radiation oncology at the University of Pennsylvania, stressed that there are alternatives to the scarce drug and that the agency “will do everything possible to mitigate the shortage.”
But on Tuesday, the consumer advocacy organization Public Citizen sent letters to Hahn and three industry groups urging “full transparency" in tracking drug-supply disruptions.
"Any hint that the government is hiding important information sows distrust,” says the letter to the FDA, signed by Michael Carome, director of Public Citizen’s health research group.
Asked for a response, an FDA spokesperson said the name of the drug is considered “confidential commercial information” and manufacturers would be “less willing to provide voluntary information if they cannot trust the FDA” to keep it secret.
“While manufacturers are legally required to report drug supply disruptions to FDA ... they are not required to provide the detailed information on their supply chain that we have needed to monitor the drug supply since the onset of the outbreak,” the spokesperson emailed.
Long before the coronavirus epidemic, chronic shortfalls of many drugs, particularly generic injectables, have plagued the United States for years because of the complexity and economics of manufacturing.
The FDA’s news release said it has contacted more than 180 drugmakers — among them manufacturers of 20 drugs that get ingredients solely from China — and so far only one has reported any shortages due to a facility affected by the new virus.
About 150 prescription drugs, including antibiotics and some branded drugs without alternatives, are at risk of shortfalls because of the Chinese outbreak, according to the news website Axios.
China is a huge world supplier of pharmaceutical ingredients and finished drugs; the FDA says the country has 13% of all facilities that make components for drugs sold in the United States.
China has imposed stringent quarantine and travel restrictions to try to contain the respiratory virus, which emerged in the city of Wuhan in late December. Called COVID-19, it has sickened about 80,000 in China, of whom 2,900 have died.
The Public Citizen letter asked three pharmaceutical and biotech-industry groups to “encourage your member companies to publicly disclose the names of their specific drugs or biological products that are involved in any shortage resulting” from the epidemic.
“Important public health interests must take precedence over any purported industry interest in keeping such information secret,” the letter said.