University of Philippines Manila

UPCP, FDA hold seminar promoting the use of generic drugs

The Food and Drug Administration (FDA), in cooperation with the UP College of Pharmacy, organized an onsite advocacy event entitled, “GENERIC DRUGS: Abot Kaya at Mabisa,” as part of the celebration of the Generics Awareness Month on Sept. 21, at the Emilio T. Yap Auditorium.

Pharmacy students from different schools Adamson University, Emilio Aguinaldo College, Centro Escolar University, University of Sto. Tomas, University of Makati, Manila Central University, and Our Lady of Fatima University, and UP Manila and healthcare practitioners from Bicol Medical Center and Fabella Hospital participated in this event.

In his welcome remarks, UP College of Pharmacy Dean Francis R. Capule emphasized the role of the pharmacist in ensuring access to health, a secure supply chain, and responsible use of medicines.
“Pharmacists promote awareness about generics and ensure the availability of safe, effective, quality, and affordable generic medicines. It is crucial for pharmacists to dispel misconceptions about generic drugs,” he stated. He acknowledged the support of the participants for the collective advocacy in promoting generic drugs by attending the seminar.

Mr. Rochel M. Floron IV, FDA Policy Planning Service Information Officer II under the Advocacy Section, gave an overview of the FDA, including its vision and mission, which is to be an “excellent center in health product regulation” by “guaranteeing the safety, quality, purity, and efficacy of health products in order to protect and promote the right to health of the general public,” functions, and tasks.

After introducing the theme of this year’s Generics Awareness Month which was: “Kalusugan ay Palakasin, Generics, Ating Tangkilikin;” Dr. Irene V. Florentino-Fariñas, Officer in Charge and Director III at the FDA Policy Planning Service, stated that generics are technically “duplicates of the innovator” as they are similar in terms of safety, quality, and efficacy but different in that generics are cheaper.

She discussed the Republic Act No. 6675, more commonly known as the Generics Act of 1988, which is the statute that ensures the availability of generic prescribing. She provided the mandates and penalties provided for by the law, other administrative orders relevant to the implementation of RA 6675, and the role of FDA in ensuring that such provisions are adequately enforced.

Dr. Florentino-Fariñas emphasized that all these issuances are based on ASEAN standards, therefore allowing the Philippines to be at par with what is done abroad. She followed this up with assurance that “we [FDA] are actually doing our job.”

Responding to a query on what student pharmacists can do to advocate for the Generics Act in terms of educating and engaging the community, she stated that students can become resource persons and teach those close to them what the Generics Act is about. Dr. Floron also said that young student pharmacists can be good sources of information. They can address misconceptions through the responsible use of social media.

On abolishing substandard and counterfeit medicines, they stated that the FDA works in collaboration with the PNP and PDEA adding that while they have police power, they do not have police personnel. Not all operations are reported in the media because of the need for discretion in conducting seizure operations. They also emphasized that the public may utilize their e-report system and verification portal to ensure that products are duly registered with the FDA.

On perceived barriers to increasing the generics manufacturing capacity, Dr. Florentino-Fariñas claimed that it is the lack of capital, rather than regulatory barriers, that mainly causes this hindrance as it takes billions to invest and construct a manufacturing facility.

The FDA is currently working on establishing green lanes to prioritize those who wish to get a license to operate a local manufacturing company. However, the FDA also assures that they adhere to the resilience pathway wherein drug preparations that have passed standards are accepted and those readily available from other countries will only need to submit a dossier. Hence, the lack of urgency for the country to manufacture these drugs.

The speakers encouraged businessmen to invest and establish generic medicines manufacturing in the Philippines and expressed the need for them to sustain compliance with the provisions of the law to continue their operations.

(Summarized from the FB post of Danielle Marie Labradores)

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