The Ministry of Food and Drug Safety has begun reassessing the efficacy of choline alfoscerate, a prescription drug for dementia, to consider re-classifying it as a functional food. However, it could take much time for the regulator to review all the data and come up with a social consensus, observers said.
After lawmakers pointed out that classifying choline alfoscerate as prescription medicine was a waste of the national health insurance cost at a parliamentary audit in October, the ministry requested pharmaceutical companies to submit materials related to the efficacy of choline alfoscerate.
Materials the regulator requested include data demonstrating the efficacy of choline alfoscerate as approved, domestic and foreign use status, comments on changes to licensing approval conditions and proposed changes to the license, and general opinions on the agent’s effectiveness and the company’s plan.
The food and drug safety ministry said Wednesday that more than 100 companies out of 130 that received the request have completed the data submission by Nov. 11.
The ministry noted that to evaluate the effectiveness of choline alfoscerate, it needed not only scientific evidence but a social consensus, including experts’ opinions.
“To evaluate the efficacy of the agent, we will conduct reviews on various materials including overseas documents and domestic data,” the ministry said. “As more than 70 percent of the companies have actively replied to our request, we will have a full range of re-assessment.”
The ministry went on to say that physicians still argue that patients need choline alfoscerate because no treatment directly cures dementia. Thus, the government needs to reflect doctors’ opinions, as well as data from the industry, the ministry emphasized.
As the ministry would need to review not only data from the industry but neurologists’ opinions for dementia treatment, overseas cases, and report to the National Assembly, it would take considerable time until the ministry announces the final result, according to industry officials.
In the parliamentary audit in October, the Ministry of Health and Welfare said it would complete the re-evaluation of choline alfoscerate’s validity for reimbursement by June next year.