FDA expedite review and approval of lifesaving Cuban antiviral for COVID-19

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                                                   March 29, 2020

Via email to Stephen.Hahn@fda.hhs.gov 


Steven Hahn, M.D.

United States Commissioner of Food and Drugs

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993                             

          Re: FDA approval of recombinant human interferon alfa-2B to treat COVID-19

Dear Commissioner Hahn:

At this time of global pandemic which threatens the lives and livelihoods of millions of people in the United States and billions worldwide, it is crucial that our public health and political leaders seek viable, science-driven solutions wherever they may be found, regardless of politics.

One of many such sources of potential aid is recombinant human interferon alfa-2B (Alfa 2-B), one of some 30 medicines now being used in China and Italy to counter the adverse health effects of the COVID-19 pandemic. Alfa-2B was developed by Cuban scientists in collaboration with a Houston-based U.S. physician, Dr. Lee Clark.  Strong scientific evidence supports the antiviral effect of Alfa 2-B, as part of the first line of antiviral defense, activating both the innate immune response against the virus and the mechanism of inhibition of viral replication.

In the current pandemic, Alfa-2B produced by the Cuban-Chinese joint venture Changheber has been used in a nebulized form and combined with other antivirals to treat COVID-19 patients. Nebulization has been used in China “because it is a fast means of getting to the lungs and acts in the early stage of the infection,” according to Dr. Eduardo Martínez Díaz, president of the Cuban Biotechnological and Pharmaceutical Industries Group.

Preliminary results indicate Alfa-2B has positive results, especially if administered as a preventive or at the earliest stages of infection. (As with other drugs, Alfa-2B may cause adverse reactions in some patients.) Prior to the current pandemic, Alfa 2-B has been used successfully to treat Dengue, hepatitis B and C viruses, oncological-hematological diseases, as well as carcinomas and cancerous and non-cancerous tumors. 

As one of the measures taken by the Obama administration to relax the embargo or blockade on Cuba and move towards normalization of relations between the two countries, in October 2016 the Office of Foreign Assets Control (OFAC) of the U.S. Treasury Department approved regulations that authorize U.S.-Cuba scientific collaboration and Food and Drug Administration (FDA) approval for marketing of Cuban pharmaceuticals in the United States.  

Specifically, Section 515.547 of Title 31 of the Code of Federal Regulations authorizes transactions incident to obtaining approval from the U.S. Food and Drug Administration (FDA) of Cuban-origin pharmaceuticals. The “general license,” which does not require specific pre-approval from OFAC, 

“includes discovery and development, pre-clinical research, clinical research, regulatory review, regulatory approval and licensing, regulatory post-market activities, and the importation into the United States of Cuban-origin pharmaceuticals. Section 515.547 also now authorizes the importation into the United States, and the marketing, sale, or other distribution in the United States, of FDA approved Cuban-origin pharmaceuticals. In addition, revised section 515.547 authorizes persons subject to U.S. jurisdiction who are engaging in such authorized activities to open, maintain, and close bank accounts at Cuban financial institutions as long as such accounts are used solely for the authorized activities.” 

Although many of the measures taken by the Obama administration in relation to Cuba have been repealed by the current Administration, this measure has survived. 

We therefore urge that the FDA immediately implement the process for expedited approval of the sale and use of Alfa-2B to treat people in the United States, as a matter of the utmost humanitarian urgency.  We demand that politics not interfere with the science needed to save lives now.

With utmost urgency,