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Drug regulator under fire for going too far, too late
  • By Lee Han-soo
  • Published 2019.09.27 17:48
  • Updated 2019.09.27 17:48
  • comments 0

The Ministry of Food and Drug Safety (MFDS)'s ability and credibility are in doubt, as hospitals and doctors are criticizing it for responding excessively and belatedly to the current controversy about ranitidine heartburn drug

The ministry has suspended the manufacturing and selling of 269 ranitidine-using medicines after detecting a carcinogen, N-Nitrosodimethylamine (NDMA), prohibiting hospitals from prescribing ranitidine-based medications from 1:00 a.m. Thursday.

Hospitals had voluntarily deleted codes for ranitidine-based gastrointestinal drugs and began prescribing alternatives such as famotidine, cimetidine and proton-pump inhibitors. They are criticizing the ministry, saying it is overreacting to the controversy because of the “valsartan incident” last year caused by cancer-causing elements in high blood-pressure drugs.

The medical community said that instead of making the sudden announcement, the ministry should have instructed each drug company to inspect raw material samples for manufactured drugs as well as conducted a thorough monitoring program.

Industry officials note that the fact that the ministry, which exists for public health, is still taking the same approach as the valsartan incident and has no other precautionary measures, raising questions about its expertise.

"The MFDS is trying to pass the buck to hospitals and the Ministry of Health and Welfare, something a responsible government agency should not do," a hospital official said. "If the ministry was to discontinue the use of a drug or retrieve it, it must take appropriate procedures to follow up on its action."

If MFDS fails to take such a procedure, that only shows the ministry is incompetent, he said.

The official went on to say that the MFDS appears to be an agency that stops at providing safety information without taking responsibility when things go wrong.

The Korean Medical Association (KMA) agreed with hospitals.

"The agency's response is similar to the one taken during the valsartan incident last year," the KMA said in a statement. "The ministry claims that it is strictly managing the raw materials of pharmaceuticals, but there has been no change over the past year."

It is natural to wonder what the ministry can do independently and actively, besides confirming the announcements made by foreign regulators, it pointed out, criticizing the ministry's sudden change in its stance toward ranitidine-based heartburn drugs.

"The ministry announced that it did not detect NDMA after testing Zantac, GSK's Ranitidine-based gastric antiacids, and raw material factories used for Zantac," the group said. "Barely 10 days later, however, MDFS suspended the manufacturing, importing and selling 269 Ranitidine-based heartburn drugs, saying it had completely investigated all ranitidine-based drugs manufactured in Korea."

It is impossible to trust the ministry's conclusions as it has taken no preemptive inspection or shown active monitoring ability while blindly following the moves of its foreign counterparts, the group added.

The doctors’ group suggested that to resolve the lack of expertise, the ministry should take more active control through covert collection and inspection of medicines while securing sufficient professional personnel to enhance expertise.

"If the agency goes on like this, patients and doctors will become the biggest victims," the KMA said. "It is up to the MFDS and pharmaceutical companies to resolve patient misunderstandings, complaints, and anxieties regarding drugs."

On the other hand, some in the medical community sided with the ministry, arguing that MFDS's response was appropriate.

"It would have been difficult for the regulatory agency to conduct an NDMA detection as the drug was FDA-approved," said Nam Goong-in, a doctor at Ewha Womans University Mokdong Hospital. "Besides, the ministry's decision to halt the distribution of drugs used for 30 years would have needed sufficient and concrete evidence."

However, the ministry should still learn a lesson as its first and second announcement contradicted each other and that it lagged behind foreign agencies in taking the countermeasures, Nam said.


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