[Reporter’s View] Can companies get EUAs as they promised?

The Emergency Use Authorization (EUA) system was first introduced to Korea in March last year.

 

AstraZeneca’s COVID-19 vaccine manufactured in Italy, Moderna’s COVID-19 vaccine manufactured by Samsung Biologics, Pfizer’s oral COVID-19 treatment Paxlovid, and the COVID-19 injection Remdesivir for use in patients under 15 were approved using Korea's EUA system.

 

All of the drugs above were introduced to Korea through EUA before receiving marketing authorization through an official process.

 

Among these, AstraZeneca’s vaccine that was manufactured overseas and Samsung Biologics’ Moderna vaccine are now officially approved in Korea.

 

As such, the EUA system had gained attention as the new way to introduce COVID-19 drugs before applying for marketing authorization.

 

Using this as momentum, companies have even set out goals to introduce their drugs to Korea using the EUA system.

 

Rather than applying for marketing authorization that requires a long time for review, the companies made the plan to quickly introduce their drugs using the EUA track after completing domestic clinical trials.

 

However, some have criticized that the companies are setting impractical goals and making hollow promises to raise their stock price.

 

The idea that the companies that completed clinical trials may voluntarily apply for EUA is in itself a false logic.

 

The EUA is granted only after a request from a head of a relevant agency such as the KDCA, and when the MFDS deems the drug is necessary for responding to a public health crisis.

 

Therefore, the pharmaceutical company cannot first ask authorities to grant EUA to its drugs.

 

The only way this is possible is when the MFDS issues a public notice on the scope of medical products in need.

 

Of course, there is a possibility that the companies may actively appeal the need for their drugs to the MFDS to receive EUA.

 

However, this is also quite impractical.

 

The government is in charge of introducing and purchasing COVID-19 drugs.

 

Therefore, it would be very unlikely for the MFDS to grant EUA to drugs that are not included in the purchasing agreement.

 

Therefore, the only realistic way for a drug to receive EUA is if the drug was already approved in other countries and has made a purchasing agreement with our government.

 

The 4 products that were previously granted EUA had also been first approved overseas and signed advance agreements with the Korean government.

 

Therefore, the claim of pharmaceutical companies that it will promptly introduce its drug through EUA can be considered an overstatement, deceiving investors who invested in the companies after reading promotional materials that contain such contents.

 

Pharmaceutical companies must provide accurate information about their respective companies to fulfill their ethical responsibilities.

 

They should state the feasibility and risks involved in addition to their goals.

 

If not so, their intent pursuit to raise their stock price in this COVID-19 crisis will adversely result in the loss of what should matter the most - the consumer’s trust.