“Riavax problem even noticeable for incompetent officer"

Former Committee member Kang Yoon-hee “Requested for immediate revocation of approval when found serious issue”

Professor Park In-geun “Eotaxin testing cannot be an evidence to approve Riavax”

Lawmaker Nam In-soon, “Former MFDS director meddled with the approval review, needs self-audit”

Former Clinical Trial Deliberation Committee Member of MFDS Kang Yoon-hee (left) and Professor Park In-geun of Gachon University Gil Medical Center

Witnesses at National Assembly annual audit reproached Riavax, the immunotherapeutic peptide for pancreatic cancer treatment revoked from marketing approval, has apparently submitted review materials that every researcher at Ministry of Food and Drug Safety (MFDS) would notice how they were poorly prepared.

 

Regardless of the failure in global Phase 3 clinical trial and clinical data with highly suspicious reliability, they claimed MFDS did not reject the item approval application but decided to approve the product and even ignored the request for post-review approval revocation.

 

At the National Assembly Health and Welfare Committee’ audit session on MFDS conducted on Oct.

 

13, former Clinical Trial Deliberation Committee Member of MFDS Kang Yoon-hee (M.D.) and Professor Park In-geun of Gachon University Gil Medical Center answered Democratic Party Lawmaker Nam In-soon as witnesses.

 

Lawmaker Nam summoned former Committee Member Kang, who reviewed Riavax approval materials, to point out the faults in Riavax approval review procedure MFDS sloppily handled.

 

Former Committee Member Kang answered, “The submitted evidences were reviewed in August last year, and I sent an email to high-level executives in MFDS in charge of drug approval review to request revocation of the item approval as we found serious issues in the reviewed materials,” because “the eotaxin testing used in the approval review was not approved as itself, and its credibility is so low that it cannot properly prove anything.” She stressed, “The issues found during the review were noticeable even for an incompetent researcher at MFDS.

 

The company submitted an approval application with retrospective analysis based on eotaxin and not a proper clinical trial,” and “it was approved for marketing without credible review standards.” Another witness Professor Park also addressed issues in the Riavax approval review.

 

Professor Park urged, “I suspected there could have been some sort of special treatment for the company, when I read the news the ministry approved of Riavax by retrospectively analyzing eotaxin as a biomarker,” because “eotaxin is irrelevant to Riavax, and using the retrospective analysis on 80 patients out of over 1,000 clinical trial participants as an evidence for the approval was clearly problematic.” “An item approval should be based on evidence to confirm the item whether it would benefit patients in treatment or cause harm to them,” and “Riavax’ effect was weak, and approving these kinds of drugs could eventually take away patients’ treatment opportunity,” Professor Park added.

 

Lawmaker Nam also raised suspicion that the Riavax received special treatment during the approval review as a former director of Review Coordination Division at MFDS was involved.

 

Lawmaker Nam stated, “It is difficult to comprehend how it was possible to accept the result of retrospective analysis as Phase 2 clinical trial to grant an approval with evidence in development,” and “also, it was exceptional for the ministry to approve a treatment supplementary Leukine injection by individually purchasing it when it was not even approved in South Korea.

 

The public criticized how the former director of Review Coordination Division was appointed as a vice-president of GemVax & KAEL and meddled with the review.” The lawmaker demanded, “It is problematic that a MFDS officer takes an executive position at a pharmaceutical company and leads the approval review procedure,” and that “the ministry should hand in results of its self-audit assessing the adequacy of the Riavax approval before the general audit.” A MFDS representative answered the ministry would follow Lawmaker Nam’s order.

 

Minister Lee Eui-kyung said, “Although there was misunderstanding, the transfer of the former director of Review Coordination Division to GemVax & KAEL did not seem to have violated the employment review related regulation,”