BPOM Issues Rule on Expanded Access Program for Ivermectin

TEMPO.CO, Jakarta - The Food and Drug Monitoring Agency (BPOM) issued a regulation on the use of investigational drugs or Expanded Access Programs (EAP) during emergencies.

“The approval for the use of drugs through EAP is not a distribution permit or EUA which is for the pharmaceutical industry, but it is the approval for ministries or institutions administering government affairs in the health sector or health facilities,” said the BPOM Head Penny K Lukito in a written statement on Wednesday, July 21.

In an emergency situation to deal with a life-threatening disease, Penny explained, a breakthrough for the special use of medicines that are still in the clinical trials is necessary.

According to her, the EAP has been enforced by drug regulators in several countries, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). However, the drug use must be carried out in health service facilities such as hospitals or health centers appointed by the Health Ministry, and that the dosages and rules of use must be the same as those implemented in clinical trials.

“One of the medicines that are suspected to have potential in handling Covid-19 and still requires proof through clinical trials is Ivermectin,” she remarked.

“If a wider use of Ivermectin is needed by health facilities, the Health Ministry can apply for the use under the EAP scheme, considering Ivermectin is a prescription drug,” Penny added.

The BPOM Head emphasized that the pharmaceutical industry must not promote Ivermectin, either to health workers or the public.

Read: BPOM Approves Ivermectin as Covid-19 Therapeutic Drug

ANTARA