[Reporter’s View] The transparency in COVID-19 drug review

The public is keeping a close eye on the South Korean Ministry of Food and Drug Safety (MFDS) approving the COVID-19 vaccine and treatment.

 

Especially because the pharmaceuticals and their efficacy have been controversial overseas, the public’s interest is heightened on the result of the health authority’s evaluation.

 

To guarantee an objective assessment, MFDS is consulting with experts for three times.

 

After the first verification, the Central Pharmaceutical Affairs Deliberation Committee and the Final Review Committee would conduct the second and third review on the drugs, respectively, for the final decisions Celltrion’s COVID-19 monoclonal antibody treatment candidate Rekirona has been passed by the Verification Council and the Central Pharmaceutical Affairs Deliberation Committee, and now it is waiting for the final decision by the Final Review Committee.

 

AstraZeneca’s COVID-19 vaccine also has been under the Verification Council’s review for 30 days.

 

Regardless of the thorough consultation with three groups of the experts, the public is still skeptic about the objectivity of the review.

 

The public suspects the final decision has been made already, as the health authority addressed the projected approval date on those COVID-19 vaccine and treatment during a briefing session, and politicians are also commenting about the specific date.

 

Now the people are concerned the groups of experts would not be able to make an objective decision as the government and politicians have built an environment strongly pushing for a positive result.

 

In fact, Celltrion’s COVID-19 monoclonal antibody is apparently lacking sufficient data, and the efficacy of AstraZeneca’s COVID-19 vaccine on elderly population came under close scrutiny.

 

But at this point any kind of decision could be made as the experts are disputing over split views.

 

Apparently, some members of the Central Pharmaceutical Affairs Deliberation Committee are opposing against granting an official approval on Celltrion’s COVID-19 so much so that they suggested giving a special case authorization for manufacturing, instead of the approval.

 

For the people’s rights to know and transparency, MFDS is weekly updating the evaluation news on the COVID-19 vaccine and treatment candidates.

 

The ministry does realize the public’s demand for objectivity, independency and transparency on the COVID-19 vaccine and treatment are higher than ever.

 

However, a fiery controversy would be unavoidable every time the expert bodies provide the review result.

 

Even the experts struggle to make an unbiased decision on the drugs, torn between the treatment urgency and safety, as they were hastily developed for the urgent cause.

 

To eliminate the public’s suspicion and ensure transparency, the ministry should fully disclose the Central Pharmaceutical Affairs Deliberation Committee’s meeting minutes.

 

Although the ministry is supposed to disclose the meeting minutes by principle, they sometimes decide to keep the minutes confidential, causing the public to accuse the ministry of making decisions in their favor.

 

Only giving a briefing of the Central Pharmaceutical Affairs Deliberation Committee’s meeting cannot possibly resolve the public’s curiosity.

 

The public is highly suspicious of the expert groups reviewing the drugs with already-decided outcomes as the news articles are making accusations.

 

The ministry would be able to shake off the accusations only if they unveil the Central Committee’s meeting minutes without concealing a word.

 

Hopefully, MFDS would take a bold action on the matter.