Washington, DC—With so many drugs and components of pharmaceuticals manufactured in China, the FDA says it has been closely monitoring the supply chain with the expectation that the COVID-19 outbreak would likely create disruptions to supply or shortages of critical medical products in the United States.
In a statement from Stephen M. Hahn, MD, the FDA’s commissioner of food and drugs, the agency points out that a manufacturer alerted it to a shortage of a human drug that was recently added to the drug-shortages list, citing the effects of coronavirus.
“Since January 24, the FDA has been in touch with more than 180 manufacturers of human drugs, not only to remind them of applicable legal requirements for notifying the FDA of any anticipated supply disruptions, but also asking them to evaluate their entire supply chain, including active pharmaceutical ingredients (the main ingredient in the drug and part that produces the intended effects, e.g., acetaminophen) and other components manufactured in China,” according to the statement.
Also, as part of its efforts, the FDA says it has identified about 20 other drugs that solely source their active pharmaceutical ingredients or finished drug products from China, adding, “We have been in contact with those firms to assess whether they face any drug shortage risks due to the outbreak. None of these firms have reported any shortage to date. Also, these drugs are considered non-critical drugs.”
Shortages related to the coronavirus in China are unlikely to affect biologics, however. The FDA notes that, as far as it is aware, no cellular or gene therapies are made in China for the U.S. market.
Hahn points out that four specific proposals in President Trump’s budget proposal would better equip the FDA to prevent or mitigate medical-product shortages. Those include:
• Lengthening expiration dates to mitigate critical human-drug shortages
• Improving critical infrastructure by requiring risk-management plans from some drug manufacturers
• Improving data sharing and requiring more accurate supply chain information
• Requiring reporting by device manufacturers.
“Shortages of certain critical drugs can be exacerbated when drugs must be discarded because they exceed a labeled shelf-life due to unnecessarily short expiration dates,” Dr. Hahn said. “By expanding the FDA’s authority to require, when likely to help prevent or mitigate a shortage, that an applicant evaluate, submit studies to the FDA, and label a product with the longest possible expiration date that the FDA agrees is scientifically justified, there could be more supply available to alleviate the drug shortage or the severity of a shortage.”
He also emphasizes that, at present, “many medical product manufacturers lack plans to assess and address vulnerabilities in their manufacturing supply chain, putting them, and American patients, at risk for drug supply disruptions following disasters (e.g., hurricanes) or in other circumstances.”
At the same time, the agency says it is aggressively monitoring the market for any fraudulent COVID-19 diagnosis, prevention, or treatment claims. Dr. Hahn warned, “The FDA can and will use every authority at our disposal to protect consumers from bad actors who 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.”
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In a statement from Stephen M. Hahn, MD, the FDA’s commissioner of food and drugs, the agency points out that a manufacturer alerted it to a shortage of a human drug that was recently added to the drug-shortages list, citing the effects of coronavirus.
“Since January 24, the FDA has been in touch with more than 180 manufacturers of human drugs, not only to remind them of applicable legal requirements for notifying the FDA of any anticipated supply disruptions, but also asking them to evaluate their entire supply chain, including active pharmaceutical ingredients (the main ingredient in the drug and part that produces the intended effects, e.g., acetaminophen) and other components manufactured in China,” according to the statement.
Also, as part of its efforts, the FDA says it has identified about 20 other drugs that solely source their active pharmaceutical ingredients or finished drug products from China, adding, “We have been in contact with those firms to assess whether they face any drug shortage risks due to the outbreak. None of these firms have reported any shortage to date. Also, these drugs are considered non-critical drugs.”
Shortages related to the coronavirus in China are unlikely to affect biologics, however. The FDA notes that, as far as it is aware, no cellular or gene therapies are made in China for the U.S. market.
Hahn points out that four specific proposals in President Trump’s budget proposal would better equip the FDA to prevent or mitigate medical-product shortages. Those include:
• Lengthening expiration dates to mitigate critical human-drug shortages
• Improving critical infrastructure by requiring risk-management plans from some drug manufacturers
• Improving data sharing and requiring more accurate supply chain information
• Requiring reporting by device manufacturers.
“Shortages of certain critical drugs can be exacerbated when drugs must be discarded because they exceed a labeled shelf-life due to unnecessarily short expiration dates,” Dr. Hahn said. “By expanding the FDA’s authority to require, when likely to help prevent or mitigate a shortage, that an applicant evaluate, submit studies to the FDA, and label a product with the longest possible expiration date that the FDA agrees is scientifically justified, there could be more supply available to alleviate the drug shortage or the severity of a shortage.”
He also emphasizes that, at present, “many medical product manufacturers lack plans to assess and address vulnerabilities in their manufacturing supply chain, putting them, and American patients, at risk for drug supply disruptions following disasters (e.g., hurricanes) or in other circumstances.”
At the same time, the agency says it is aggressively monitoring the market for any fraudulent COVID-19 diagnosis, prevention, or treatment claims. Dr. Hahn warned, “The FDA can and will use every authority at our disposal to protect consumers from bad actors who 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.”
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