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‘Unnecessary delay’ sa pag-apruba ng generic drugs nakababahala – deputy speaker

‘Unnecessary delay’ sa pag-apruba ng generic drugs nakababahala – deputy speaker

NAGPAHAYAG ng pagkabahala si House Deputy Speaker Bernadette Herrera sa animo’y ‘unnecessary delay’ sa pag-apruba ng first-time generic medicines para sa chronic diseases kagaya ng diabetes at hypertension.
 
Ani Herrera, isang uri ng pagkakait sa mga taong nangangailangan ng “affordable life-saving drugs.”
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Tinawag ni Herrera ang pansin ng Food and Drug Administration (FDA) sa mabagal na aksiyon nito hingil sa nakabinbin na aplikasyon ng daang-daang certificate of product registration (CPR) na isinumite ng pharmaceutical companies.
 
“Why is the FDA taking so long to approve these generic drugs when it knows for a fact that the timely availability of these medicines would increase affordability for many Filipinos?” tanong ni Herrera.
 
Paliwanag niya, ang generic version ay ginawa kagaya ng mga branded na produkto at nagdudulot ng parehong epekto.
 
Mula Disyembre 2019 hangang Hulyo 2020, mga aplikasyon sa first-time generic drugs kagaya ng ivabradine, rivaroxavan, dapagliflozin, ticagrelor, mecobalamin+pregabalin, canagliflozin, and tenofovir alafenamide ay naisumite na sa FDA.
 
Ang Dapagliflozin at canagliflozin ay para sa diabetes, ang tenofovir alafenamide ay para sa chronic hepatitis B infection at iba pang sakit sa atay. ‘Yung ibang mga gamot ay para sa high-blood, stroke, heart attack.
 
Giit ni Herrera, babagsak ang presyo ng mga gamot ng 30-40 porsiyento kapag inaprub ng FDA.
 
“If FDA prioritizes release and evaluation of products like these, there will be more choices of medicines in the market,” aniya. “More options means lower cost.”
 
“If we strictly follow the Anti-Red Tape Act (ARTA) of 2018, these applications are already deemed automatically renewed,” ayon kay Herrera, isa sa mga awtor ng ARTA law.
 
“It is important to point out that these products are not new in the market as they were already tested for safety, efficacy and quality. The public has been using these products for some time so there’s little to no risk already,” dagdag niya.
 
Naunang sinabi ng Philippine Chamber of Pharmaceutical Industry Inc. (PCPII) at ng Philippine Pharmaceutical Manufacturers Association (PPMA) sa pagdinig sa Kamara na “1,025 applications for CPR, 18 for license to operate, and 381 for automatic renewal have been pending with the FDA as of last March 29.”
 
“Ano ba ‘yan, ang daming pending at ang bagal ng aksiyon. We hope the FDA will do something about this ASAP,” ani Herrera. (GERRY BALDO)

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