[Reporter’s view] MFDS’ eyebrow-raising review dependency

Obviously not true, but a series of recent incidents have gotten the public skeptical about Korea’s Ministry of Food and Drug Safety’s (MFDS) independent pharmaceutical review capacity.

 

Many of recent safety issues have surfaced from overseas, and none of them were first found in Korea.

 

Merely in a day, the ministry decided to copy the U.S.

 

Food and Drug Administration’s (FDA) official action to ban sales of an appetite suppressant, Belviq (lorcaserin), due to its cancerous risk.

 

While FDA has reported Belviq’s risk of causing cancer last month and issued a recommendation to pullback the item from market on Feb.

 

13, MFDS not only did not have a chance to review clinical data that raised the issue but also was unable to acquire it.

 

And apparently, European Medicines Agency (EMA) had known about the cancerous risk before and refused to approve the item.

 

So the public naturally started questioning MFDS’ ability to review pharmaceuticals properly by itself.

 

In another instance, Korean-made cell and gene therapy ‘Invossa’ made a ruckus last year, leaving MFDS’s review ability seem even more questionable.

 

Besides the developer Kolon Life Science’s ethics issues, one could wonder if MFDS could have filtered it out during the approval review procedure from the first place.

 

When reviewing thousands of pages of pharmaceutical data, lack of review reviewing capacity or company’s deceptive data could be considered their inevitable limitation.

 

But maybe it is time to rethink if it isn’t merely an excuse.

 

How could MFDS be clueless until some problem arises?

 

If it was not for the U.S.

 

regulator pinpointing the clinical procedure, Invossa could have been used on patients without knowing that the key active pharmaceutical ingredient was switched.

 

MFDS has retroactively banned sales of anti-hypertension substance valsartan and stomach ulcer treatment ranitidine, when a report of cancerous impurity found was issued from overseas.

 

As the ministry took a strict action on the matter, the public’s criticism on the ministry’s timing of recognizing the issue was relatively mild.

 

But we are left with no answers as to why the Koreans are late in the game to realize such problems.

 

Former MFDS Clinical Trial Review Committee member Kang Yoon-hee, who received disciplinary action with an issue reported by a whistle-blower and had her contract terminated, claimed MFDS lacks ability to review independently.

 

She argued MFDS basically imitates decisions by other overseas health regulators.

 

Specifically for first-in-class drugs, the ministry has never proactively approved any without FDA or EMA’s decision.

 

She reproached MFDS is not ‘reviewing,’ but is ‘learning’ from other’s decisions.

 

Kang’s criticism may have neglected the reality, but her comment should not be overlooked.

 

It is time for MFDS to assess itself on what is the cause of such dependency on foreign institutes, on lack of qualified human resources, and on problems in reporting procedure or review system.