Anti-red tape body asks FDA to explain inaction on 600 applications


Posted at May 14 2021 03:26 PM

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The Anti-Red Tape Authority (ARTA) said on Friday it has asked a unit of the Food and Drug Administration to explain its inaction over some 600 applications from pharmaceutical firms. 

Some of the applications that the Center for Drug Regulation and Research (CDRR) has yet to process were filed "as far back as 2013 or 2014," said ARTA Director General Jeremiah Belgica. 

The applications from 22 or 23 firms concern products that are already in the market. The companies are just required to submit an affidavit that there was no change in the products' formulation, he said in a televised public briefing.

The anti-corruption body last Tuesday send the CDRR a show cause order to explain why it should not face administrative or criminal cases over the pending applications, Belgica said. 

The delays were observed despite reforms that FDA Director General Eric Domingo enforced within the agency, including automation and streamlining of processes, said Belgica. 
“Ang aming hiling po sa kanila is i-release po nila lahat ng pending nila doon na lagpas-lagpas na ng panahon,” he said. 

(Our appeal to them is that they release all pending applications that have taken too much time.)

He said ARTA would ask help from the Presidential Anti-Corruption Commission to do a lifestyle check on CDRR members. 

“‘Pag meron pong red tape na ganyan, hindi ho nalalayo ang korapsyon,” said the ARTA chief, whose brother Greco Belgica chairs PACC. 

(When there is red tape, corruption is not far off.)

Domingo has yet to reply to ABS-CBN News' request for comment as of this posting.