MFDS to tighten up regulations on appetite suppressant

Government unveils drafted management plan on regulating psychoactive appetite suppressant use

Same management system for narcotic drug to be applied

Industry “Approach inadequate for the ultimate goal”

The South Korean health authority drafted regulations preventing the abuse of psychoactive appetite suppressants.

 

The draft contains high-level of regulations like adopting active substance designation system used in narcotics control, which can heavily impact the relevant industry.

 

According to pharmaceutical industry sources on July 24, Korea’s Ministry of Food and Drug Safety (MFDS) is planning to manage psychoactive appetite suppressants.

 

Some of the approaches unveiled were introducing quarterly active substance designation system like the narcotics control, notifying amfepramone and mazindol as restricted substance, and designating psychoactive appetite suppressants as subjects to submit a risk management plan (RMP).

 

Psychoactive appetite suppressant management plan drafted by MFDS

First, the quarterly substance designation system is used by the government to control narcotic drugs in Korea in accordance to the Single Convention on Narcotic Drugs of 1961.

 

The government intends to enforce the system to handle the appetite suppressant on the equivalent level to narcotic drugs.

 

The current system designates each company on which narcotic substance to supply after reviewing the projected yearly use volume of narcotic substance and quarterly plan of active psychoactive drug use submitted by each supplier company from the previous year.

 

When the result is notified to each company, the narcotic drug manufacturers are allowed to purchase the active substance strictly following the designation conditions.

 

MFDS sketched out a plan to survey each company’s inventory this year, and enforce the new regulation from 2021 after finalizing and notifying the appetite suppressant manufacturing approval plan in November.

 

When the new regulation comes in effect, the drug manufacturers can only manufacture the suppressant drugs as much as the government allows.

 

Basically, the government would be invested with the power to set down the manufacturing volume of psychoactive appetite suppressant.

 

Moreover, the government aims to newly restrict approval on amfepramone and mazindol.

 

The official notification would be issued around August.

 

In the past, the approval on phentermine and phendimetrazine has been restricted due to frequent reports of abuse.

 

The ministry now plans to expand the restricted scope of substances and include amfepramone and mazindol.

 

The designated substance drugs may be restricted when seeking for narcotic drug handling approval, manufacturing or importation approval.

 

Lastly, the ministry plans to designate psychoactive appetite suppressants as drugs required to submit a RMP.

 

The system usually targets new drug or orphan drug, but a drug the Minister of Food and Drug Safety acknowledges the need for RMP submission due to severe adverse reaction reported may also be designated.

 

MFDS is shooting for early next year to enforce the designation.

 

Pharmaceutical companies with drugs required to submit RMP have to comply with the plan and regularly submit evaluation result.

 

Until the final designation is announced, the ministry is to recommend the companies to voluntarily practice risk minimization actions as a pilot program.

 

Also the government body would soon survey demands on the pilot program from the participating companies.

 

On July 21, MFDS convened a conference with the affected industry and shared the said details.

 

The ministry would make final decisions after reviewing the industry’s opinion.

 

Regardless of the abuse prevention and safe use policies enforced on appetite suppressants so far, MFDS has decided to take the stricter action as the drugs were still excessively prescribed.

 

In 12 months time from July 2018 through June 2019, 24,000 healthcare institutes prescribed the appetite suppressants to 1.29 million patients, which adds up to 6.11 million cases of dispensing and use of the drugs.

 

According to 2018-2019 technical reports published by International Narcotics Control Board (INCB), Korea’s phentermine and phendimetrazine substance importation volume is one of the highest in the world.

 

Analyzing appetite suppressant prescription and administration data, the report confirmed frequent cases of abnormal use suspected of abuse.

 

And apparently, these drugs have been globally criticized for the wide discrepancies between the submitted projection psychoactive drug substance use volume and the actual manufactured volume.

 

However, the relevant industry points out the blueprint of the regulation do not match with the goal of preventing drug abuse.

 

An industry insider who requested anonymity noted, “The government should rather actively promote drug administration instruction or safe use, if the drug abuse is the issue.

 

Many of the industry associates say regulating and controlling the actual manufacturing and production of the drugs is inadequate.” Meanwhile, the obesity treatment market in Korea, including the psychoactive appetite suppressant market, is valued at approximately 150 billion won.