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FDA backlog catches attention of anti-red tape body

/ 05:06 AM September 03, 2019

The Anti-Red Tape Authority (Arta) is considering to order the automatic approval of over 2,000 drug applications pending for renewal before the Food and Drug Administration (FDA).

Top officials of the Arta and the FDA met on Monday to discuss how the latter would address the mounting backlog, which covers various products such as food, drugs and cosmetics.

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It was revealed during the meeting, which was opened to the media, that 2,083 renewal cases for existing drugs have been with the FDA beyond the accepted number of days under Republic Act 11032.

The law prescribes that government agencies have to process permits within three to 20 days, depending on how complex or technical the papers are. The processing could be extended once for another 20 days.

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No formal order has been issued yet, but according to Arta Director General Jeremiah Belgica, this is “the direction we’re seeing right now.”

“We would really push that [these] should be automatically approved,” he told reporters on the sidelines of the meeting. He said the applications would just then be subjected to post-evaluations.

“One of their problems is that sometimes, when a [company] applies, the [information] about their product is not true, so that’s what they want to guard against. But that’s also why you have an affidavit of undertaking,” he said. This means that the companies vow to the truthfulness in the information attached to their products, thus findings that prove otherwise would lead to the company being charged for perjury.

But more than clearing the FDA’s backlog, the Arta official said the agency should apply information technology solutions to its processes, while rationalizing its policies and regulations for a smoother flow.

He said the Arta had initiated the meeting, even as it has been receiving complaints of the FDA backlog.

The law penalizes government officials who could not follow the prescribed time period, such as suspension for the first offense and then an administrative and criminal liability for the second offense.

It is not clear if anyone would be penalized, since Belgica said the problems faced by FDA did not seem “intentional.”

“I wouldn’t also absolve them. It’s not right for us to absolve anyone yet. What I’m going to say is [we would] really look into it. If someone needs to be charged, then we wouldn’t think twice,” he said.

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TAGS: Anti-Red Tape Authority (Arta), Business, FDA, Food and Drug Administration (FDA)
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