One of the misteries that occationally happens in MHLW sites
The site I could find easily yesterday suddenly disappeared! It was a product information of MEFEEGO Pack with the sign of "Deleterious product." I searched the site of the Ministry of Health, Labour and Welfare and found a new URL for the product information with the "deleterious" sign:
https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/841049_249910AX1028_1_02
Along the process, I also found a new "Report of Deliberations" issued on April 26, 2023 by the Drug Evaluation and Administration Division of the Pharmaceuticals and Consumer Health Bureau of MHLW. The two-page report was added on top of the "Report of Examination" provided at the time of gathering pubic comments during last February.
https://www.pmda.go.jp/drugs/2023/P20230501001/841049000_30500AMX00126_A100_1.pdf
The translated content of this added document includes as follows:(original in Japanese)
Report of Deliberations
April 26, 2023
Drug Evaluation and Control Division, Pharmaceuticals and Consumer Health Bureau
［Marketing Name］ Mefeego Pack
［Generic Name] Mifepristone, Misoprostol
[Applicant's Name] Linepharma K.K.
［Date of Application] December 22, 2021
［Results of deliberation］
The First Subcommittee of the Pharmaceutical Affairs and Food Sanitation Council held on January 27, 2023 approved this item and decided to submit it to the Pharmaceutical Affairs Subcommittee of the Pharmaceutical Affairs and Food Sanitation Council.
At the Pharmaceutical Affairs Subcommittee meeting held on April 21, 2023, it was decided that approval is acceptable on the assumption that the following handling will take place.
- For the time being, the patients should be admitted to a facility with beds that can accommodate them or be treated on an outpatient basis (in-hospital standby is mandatory) until an appropriate system for emergency use has been established. Regarding the "period of time until the appropriate system for use is established," a notice will be issued stating that sufficient post-marketing surveillance and research will be conducted to evaluate the appropriate medical coordination system, and the results will be used as the basis for consideration and decision making.
- Regarding distribution and use management, a procedure manual should be established to require the manufacturer/distributor and each medical institution to report monthly to prefectural medical associations the volume of sales and the volume of use (number of abortions), respectively, and the manufacturer/distributor should be required to stipulate this as a "necessary measure" in the conditions of approval. Prefectural medical associations will be required to supervise the reporting by checking the consistency of the content of both reports.
- In order to enhance the provision of correct information, the applicant should prepare materials for designated doctors under the Maternal Body Protection Law (proper use guide), and the MHLW should provide appropriate information for the public(e.g., by creating a website).
This item is not classified as either a biological product or a specified biological product, the reexamination period is eight years, and both the active ingredient and formulation of Mifepristone and the formulation of Misoprostol are classified as deleterious drugs.
［Conditions for approval]
1. A drug risk management plan should be established and properly implemented.
2. Take necessary measures to ensure that the drug is used only by designated doctors under the Maternal Body Protection Law, including the implementation of distribution and other controls in cooperation with related organizations.
The phrase "classified as a deleterious drug" was suddenly added without any explanation, which was not included in the "Review Report" issued by the Pharmaceuticals and Medical Devices Agency on November 9, 2022.
It is quite absurd that the word "deleterious drug" disappeared while public comments were being gathered, yet after two rounds of secret deliberations, when it was finally approved, it turned out to be a "deleterious drug" again.
