Why FDA Can’t Disclose the First Coronavirus-related Drug Shortage

Regulatory NewsRegulatory News | 28 February 2020 |  By 

Around 10 pm ET last night, the US Food and Drug Administration (FDA) said that it is aware of a drug shortage related to an active pharmaceutical ingredient (API) manufacturer affected by the coronavirus, but the agency stopped short of revealing what drug it is.
“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. We are working with the manufacturer as well as other manufacturers to mitigate the shortage. We will do everything possible to mitigate the shortage,” FDA Commissioner Stephen Hahn said in a statement.

An FDA spokesperson also confirmed to Focus that the agency cannot disclose the drug in shortage “as it is confidential commercial information.”
But she also explained why FDA is in a difficult position with respect to such shortages and keeping the public informed.
“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 said. “We need the cooperation of the drug companies in order to obtain accurate information as we proactively take steps to mitigate drug shortages, and companies will be less willing to provide this voluntary information if they cannot trust FDA not to disclose commercial confidential information such as drug names, company names or exact location of facilities.”

And the same law that requires FDA to post the drug shortage on its list also says the agency can withhold information in some cases.

Michael Ganio, director of pharmacy practice and quality at the American Society of Health-System Pharmacists, told Focus via email: "Our understanding of the Food and Drug Administration Safety and Innovation Act is that once a shortage of a drug has been determined, it must go on the list (21 USC 356e). However, a section of that legislation also allows the FDA to use discretion in not making information public if they determine that disclosing the shortage could adversely affect public health."
In this case, FDA did say it was recently added to its drug shortages list, and recent additions include Allergan’s treatment for complicated intra-abdominal infections, Avycaz (ceftazidime and avibactam), Mylan’s blood pressure drug pindolol 10mg (and Sun Pharmaceutical offers the same drug), and Pfizer’s chemotherapy fludarabine phosphate for injection.

Allergan told Focus in a statement: “We are experiencing an out of stock situation for AVYCAZ (ceftazidime and avibactam) for injection (2.5g) as we await regulatory approval on a new third-party manufacturer, which will ultimately allow us to continue our supply in the U.S. This situation is not related to any product or safety issue. All currently available AVYCAZ supply is unaffected and not at risk for recall…To be clear our recent drug shortage of AVYCAZ is not related to the coronavirus.” 

The reasoning behind Mylan and Sun’s shortages is listed as “shortage of active ingredient." Mylan told Focus that this shortage is not linked to the coronavirus.

"In an abundance of caution, Mylan communicated a potential, temporary gap in supply for its Pindolol 10 mg, which represents less than 30% of what Mylan supplies to the market as compared to the 5 mg strength, which represents the majority of prescriptions dispensed. The company has since secured the API stock for the 10 mg version of this product and will be returning to full supply in the coming days. Mylan is one of 4 companies supplying this product, and many therapeutically equivalent alternatives are on the market. The company does not anticipate any financial impact due to this situation," the company said.

And for fludarabine, the FDA listing says the discontinuation of the manufacture of the drug is due to an API supplier market exit. The current supply is expected to be exhausted next August.

A Pfizer spokesperson told Focus the shortage "is completely unrelated and pre-dates the outbreak...The majority of our finished product and active pharmaceutical ingredient are sourced from countries other than China. To date, we have not seen a disruption to our supply as a result of the virus."

FDA Statement

Editor's note: Article updated on 3/2/20 with comment from Mylan.


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