[Reporter’s View] MFDS provides support for drug shortages

A thyroid cancer treatment ‘Theracap’ was once listed on a “Drug Shortages Database,” where suspension of the supply or shortages are listed as current, of the Ministry of Food and Drug Safety (MFDS)’s Drug Safety website and then removed.

 

Saehan Industry expected the drug shortage and notified the MFDS of its suspension in accordance with the ‘Regulation on Safety of Pharmaceuticals (Ordinance of the Prime Minister), which states that when a marketing authorization holder of medicinal product discontinues production, importation, or supply of drug products, they must report to the MFDS the reasons no later than 60 days before the suspension day.

 

Shortly after the notification, Theracap was removed from the Drug Shortages Database.

 

Saehan Industry said reduced demand and an increase in raw materials produced in a manufacturing plant in Braunschweig, Germany, are the causes of drug shortages.

 

After the MFDS let the company know that it would review possible administrative supports, the company likely withdrew reports of suspension of the drugs.

 

Saehan Industry said, “We are internally reviewing alternative measures to produce the products instead of approval cancellation.” The MFDS anticipated that because 'Sodium Iodide(131I),' the active ingredient of Theracap, has been designated as an essential medicine, approval cancellation of the product due to a raw material issue would, in turn, affect patients.

 

The MFDS already has various administrative support measures to resolve drug shortages after experiencing acetaminophen shortages during COVID-19.

 

However, many small pharmaceutical companies are not aware of the administrative support provided by the MFDS.

 

This year, the MFDS established a pharmaceutical management and support team and enhanced the management of items of drug shortages.

 

Suppose other companies have difficulties manufacturing pharmaceuticals, such as National Essential Drugs, similar to the case of Saehan Industry.

 

They may knock on the MFDS’ pharmaceutical management and support team.

 

For instance, Bukwang Pharm’s ‘Synthyroid’ was a similar case.

 

Synthyroid is designated as a National Essential Drug, containing ‘levothyroxine’ as the active ingredient used to treat hypothyroidism.

 

Due to a recent increase in demand, it was sold out in pharmacies.

 

After multiple press coverages of drug shortages, the MFDS sent an official request to Bukwang Pharm to contact the MFDS for the administrative support they needed.

 

Bukwang Pharm needed support in relaxing the 52-hour working week for workers at the plant.

 

Consequently, the MFDS is close to negotiating with the Ministry of Employment and Labor.

 

Although the government is preparing various support measures to address drug shortages, this approach may not completely solve the shortages in clinical settings.

 

However, we hope the government’s various support measures, such as the national essential drugs, will help stabilize the supply of medicinal products.