FDA Must Be Fully Transparent During the Novel Coronavirus Pandemic

Because approximately 80% of the active ingredients used to manufacture finished prescription medications come from facilities in China — where the coronavirus pandemic originated — experts on the drug-supply chain in January began sounding the alarm about the likelihood that the outbreak would cause new drug shortages in the U.S.[1]

By late January, large-scale quarantines imposed by the Chinese government to control the spread of coronavirus had led to shutdowns of factories and transportation hubs across the country, potentially disrupting supply chains for many industries, including the pharmaceutical sector.

Thus, it came as no surprise when the Food and Drug Administration (FDA) on Feb. 27 announced the first known medication shortage linked to the coronavirus outbreak in China.[2] But disturbingly, the FDA refused to disclose the name of the medication, asserting, without justification, that such information was “confidential commercial information.”

But just two days before the FDA’s announcement, Secretary of Health and Human Services Alex Azar held a press conference at which he assured the public that his department will maintain a policy of “radical transparency” with respect to the coronavirus pandemic.[3]

Full transparency by all government agencies involved in the response to the pandemic is essential for maintaining the public’s trust. Any hint that the government is hiding important information sows distrust. The FDA’s refusal to identify the specific medication that is in shortage because of the pandemic fell far short of the level of transparency promised by Secretary Azar.

In a March 3 letter to the FDA, Public Citizen demanded that the agency immediately disclose the specific drug involved in the shortage and include such disclosures in all future announcements of shortages of drugs (or other medical products) that are linked to the coronavirus pandemic.[4] In the letter, we argued that the name of the drug involved in the coronavirus-linked shortage should not be considered confidential commercial information because disclosure of such information would not reasonably be expected to cause substantial competitive harm and because publicly traded pharmaceutical companies already have an obligation to disclose such information to their shareholders.

Moreover, important public health interests must always take precedence over any purported industry interest in keeping such information secret. For example, knowing which drug shortages are due to the coronavirus pandemic will help the medical community better understand the evolving adverse impacts of the pandemic and take actions to mitigate those impacts.

Corporate profits should not be protected at the expense of human lives. Thus, moving forward, the FDA must promptly identify the drugs involved in shortages due to the coronavirus pandemic.
 

References

[1] Silverman E. ‘The time to worry is now’: The coronavirus in China could threaten pharma’s ingredient sourcing. STAT. January 27, 2020. https://www.statnews.com/pharmalot/2020/01/27/china-coronavirus-pharmaceutical-ingredients/. Accessed March 10, 2020.

[2] Food and Drug Administration. FDA statement: Coronavirus (COVID-19) supply chain update. February 27, 2020. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-supply-chain-update. Accessed March 10, 2020.

[3] Morse M. COVID-19 is spreading rapidly abroad while immediate threat to Americans remains low, says Alex Azar. February 25, 2020. https://www.healthcarefinancenews.com/news/covid-19-cases-abroad-are-spreading-rapidly-while-immediate-threat-american-public-remains-low. Accessed March 10, 2020.

[4] Public Citizen. Letter to Stephen M. Hahn, Commissioner, Food and Drug Administration, regarding drug shortage related to the COVID-19 epidemic. March 3, 2020. https://www.citizen.org/wp-content/uploads/2508.pdf. Accessed March 10, 2020.