Coronavirus and the Pharmaceutical Supply Chain

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The novel coronavirus (also known as COVID-19) has been dominating the news media coverage these last few weeks. We don’t know what COVID-19 means for the immediate future, as the situation is very fluid and changes moment to moment. We have seen that it is capable of being transmitted in human-to-human contact and we have seen what some other countries with an outbreak have done (i.e., China and Italy with widespread quarantines). One thing not necessarily discussed much in the media is the likelihood of drug shortages, nor the is impact of such potential drug shortages, due to COVID-19, discussed much.

Congressional Letters

Rubio and Murphy

Before the COVID-19 began to spread in the United States, Senators Marco Rubio and Chris Murphy sent a letter to the Dr. Stephen Hahn, the Commissioner of the United States Food and Drug Administration (FDA). In the letter, the Senators note that the United States imported over $12 billion in food, drugs, and medical devices from China in 2018 and that China is one of the largest producers of active pharmaceutical ingredients (APIs).

The Senators write, “While the Centers for Disease Control and Prevention [CDC] stated it’s unlikely the 2019-nCoV will spread to the United States from these products, we are concerned that the pandemic could impact the FDA’s ability to monitor compliance with good manufacturing standards and the ability for Chinese manufacturers to maintain supplies to meet demand in the United States and the growing demands in China.” Despite that, they do ask whether the FDA has the resources to ensure that COVID-19 does not impact the supply of food, drugs, and devices to the United States.

Hawley

Senator Josh Hawley sent a letter to the FDA on February 24, 2020, regarding the reliance of manufacturers on China and asking for answers as to how the agency plans to “mitigate potential drug and medical device shortages.”

Pascrell and Menendez

Then, on February 25, 2020, Representative Bill Pascrell and Senator Robert Menendez also sent a letter to the FDA, opining that the outbreak is a “potentially calamitous” risk to the medical product supply chain and asking for more details on the agency’s plan to ensure the safety and security of drugs and personal protective equipment sourced from China.

FDA List of Drugs with Significant China Connections

Also, on February 25, 2020, the FDA released a list of twenty drugs that are either made in China or produced solely from APIs from China. According to the Regulatory Affairs Professionals Society, the FDA has indicated that “none of these firms has reported any shortage to date.” Further, the FDA has noted that it has been in contact with over 180 manufacturers to remind them of their responsibility to notify the FDA if they anticipate supply disruptions and to ask them to evaluate their entire supply chain for APIs and other components manufactured in China.

FDA Statement Regarding Drug Shortage

Then, on February 27, 2020, the FDA issued a statement indicating that it is aware of a drug shortage related to an API manufacturer affected by COVID-19. However, the FDA did not – and said it could not – disclose which drug is in shortage due to being confidential commercial information. Generally speaking, under the Food and Drug Administration Safety and Innovation Act, once a drug shortage has been identified, it has to go on a drug shortage list. However, the legislation also allows the FDA to use its discretion in not making certain information public if the agency finds that disclosing the shortage may adversely affect public health.

The FDA did acknowledge that it did recently add to its drug shortages list. Some recent additions include Avycaz (Allergan’s injection for complicated intra-abdominal infections) and pindolol (a high blood pressure drug offered by Sun Pharma, Mylan, Bayshore Pharmaceuticals, and ANI Pharmaceuticals).

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