MFDS allows academic marketing of EUA COVID-19 treatments

Clarifies that the drugs “may be advertised like officially approved drugs”...to improve information access for HCPs

Gi-Seok Jeong, Director-General of Special Response of the Central Disaster and Safety Countermeasure Headquarters, “Pharmaceutical companies’ provision of information will help raise prescription rate”

The Ministry of Food and Drug Safety gave an interpretation that allows academic marketing activities for oral COVID-19 treatments.

 

As drugs approved under the Emergency Use Authorization are as validly approved as officially authorized drugs, such drugs that were left unattended by the Pharmaceutical Affairs Act can also be advertised within its approved indication.

 

With this favorable interpretation, the healthcare professionals’ access to information that arose as a barrier in prescribing COVID-19 treatments will also gain momentum and be improved.

 

During a phone interview with Dailypharm on the 26th, an official from the Ministry of Food and Drug Safety said, “The Korea Disease Control and Prevention Agency is in charge of the overall management of EUA drugs, from its use volume to distribution.

 

Therefore, the KDCA needs to determine the need for the drugs’ advertisement, etc.

 

Although academic marketing is not necessary for EUA drugs as they are not directly sold by individual pharmaceutical companies, the companies may jointly provide information with the KDCA for reasons such as raising the prescription rate, etc.

 

The official added, “Applying the Pharmaceutical Affairs Act mutatis mutandis for such academic marketing activities mean that the companies that received EUAs for their drugs can advertise their products within their approved indications as the EUA is also a form of ‘authorization' subject to the mutatis mutandis application of the Pharmaceutical Affairs Act.

 

It does not mean we are forbidding academic marketing activities of pharmaceutical companies.” Until now, advertising of EUA drugs had been left in the blind spot with no clear regulations.

 

The EUA system was introduced under the Special Act on the Promotion of Development and Urgent Supply of Medical Products in Response to Public Health Crisis to promptly respond to the rise of new infectious diseases.

 

The law does not have specific regulations set for the advertisement of EUA drugs.

 

As no issues relevant to such had risen until recently, the MFDS had taken a principled position, saying that “no advertisement-related regulations are available under the Special Act, therefore the issues are applied mutatis mutandis to the Pharmaceutical Affairs Act.” Pharmaceutical companies had taken this as a “No advertising” stance, as EUA drugs are not subjects for advertisement under Article 68-5 of the Pharmaceutical Affairs Act.

 

The article specifies that an imported pharmaceutical product’s name, manufacturing method, and efficacy cannot be advertised unless the drug product has been approved or reported according to Article 42-1 of the Pharmaceutical Affairs Act.

 

If taken word by word, as drugs granted Emergency Use Authorization was not approved under Article 42-1 of the Pharmaceutical Affairs Act, such drugs are not allowed to conduct advertisements.

 

Also, at the time of introductions, when pharmaceutical companies had asked the MFDS several times on what scope of information provision activities are allowed for their EUA drugs, the MFDS only responded that “It is difficult for the ministry to provide a definite answer due to lack of information in determining the necessity and validity of providing information." The pharmaceutical companies then received the response as a “Don’t.” This was why officials from pharmaceutical companies had been passive in conducting activities for their drugs, only responding when receiving inquiries from healthcare professionals.

 

Unlike formally approved drugs, companies were unable to conduct educational or promotional activities such as directly explaining their drugs or delivering drug information to healthcare professionals.

 

However, the Advisory Committee on Infectious Diseases deems the academic marketing activities of pharmaceutical companies necessary to raise the prescription rate.

 

During a phone interview with Dailypharm, Gi-Seok Jeong, Director-General of Special Response of the Central Disaster and Safety Countermeasure Headquarters, said, “Despite the state’s efforts in encouraging the prescription of oral COVID-19, there are still many cases in which prescriptions are not available to patients who need them in the medical field.

 

Adding pharmaceutical companies' information provision activities to the effort will help increase the prescription rate.” In other words, although the KDCA is in charge of training healthcare professionals and providing medication guidance to patients, etc., for the EUA drugs, it has been experiencing limitations with the expanded number of institutions that can prescribe oral COVID-19 treatments It was found that many medical staff and pharmacists have not yet received the prescription and medication guide, which is creating confusion in the medical field.

 

This is analyzed to have also impacted the slow rise in the prescription rate of COVID-19 treatments.

 

According to the 'Measures to Raise Prescriptions of Oral COVID-19 Treatments’ that had been reported by CDSCH last month, healthcare professionals were reluctant to prescribe oral COVID-19 treatments due to a large number of contraindicated drugs and lack of clinical information.

 

Accordingly, the authorities are contemplating ways to increase accessibility to information by preparing educational materials and prescription guidelines.

 

The MFDS said that there was a miscommunication in the course of interpreting the Pharmaceutical Affairs Act.

 

Still, the MFDS is presumed to have had a negative stance on advertising activities of COVID-19 treatments in the earlier stages of introduction.

 

It is believed as the KDCA is in charge of providing information, there is no reason for the company to conduct additional academic marketing.

 

However, with the emphasis put on expanding access to information among healthcare professionals, it seems that the MFDS has broadened its scope of interpretation to “Companies may advertise if KDCA deems it necessary.” Furthermore, the MFDS has formalized its position that even drugs approved under EUA may conduct academic marketing activities just like drugs that have received official approval.

 

An MFDS official said, "As KDCA is in charge of supplying and managing the EUA drugs, companies may of course cooperate with the agency when it needs support.

 

When the KDCA requested on a similar note in the middle of this year, we answered that such activities can surely be conducted if the government deems it necessary.”