Delaying drugs

June 3, 2021 Mario Fetalino Jr. 181 views

Mario FetalinoONE story that bothered me a lot is this one concerning a unit of the Food and Drug Administration (FDA).

Weeks ago, the Center for Drug Regulatory and Research’s attention was called by the Anti-Red Authority for allegedly delaying the approval of drug applications from pharmaceutical companies.

The delay gave so much rise to suspicion at a time when all of the country is searching for possible medicines that could help stop the virus brought by COVID-19.

Now, it’s a sigh of relief to know that after the Anti-Red Tape Authority issued a show-cause order against the Center for Drug Regulation and Research under the Food and Drug Administration, some 408 drug applications were automatically approved.

“In her explanation as full compliance of the show-cause order, Jesusa Joyce N. Cirunay, Director IV of the FDA Center for Drug Regulation and Research (CDRR), said they have processed 408 out of 412 AR (automatic renewal) applications.

It cited Cirunay saying the four remaining applications are pending as two were not submitted by the client while the other two were re-routed to other centers or units.

The ARTA issued a show-cause order to Cirunay dated May 11, 2021 after it received 23 affidavits from several pharmaceutical firms that CDRR has yet to approve their renewal even though some of the applications were filed about seven years ago.

Ambica International Corporation’s application that was received by the drug center on February 2, 2017, was only approved on May 28, 2021 — almost 1,576 days or four years, three months, and 26 days from its date of application.

Under the implementing rules and regulations of the Republic Act 11032, or the Ease of Doing Business and Efficient Government Service Delivery law, government agencies are given three working days to process simple transactions, seven working days for complex transactions and 20 working days for highly technical transactions.

ARTA director general Jeremiah Belgica earlier said such renewal applications fall under simple transactions and should be processed within three working days.

The Authority is now evaluating FDA CDRR’s reply before recommending an appropriate action.

Cirunay was given until May 31 to explain to ARTA why no administrative and criminal charges should be filed against her.

The Authority is calling on the public to submit affidavit complaints if they have any pending applications with other government agencies.

On a lighter side, the continued vaccination of Filipinos against the coronavirus disease 2019 is expected to boost the domestic economy’s recovery, especially since needed programs and reform measures have been put in place before the pandemic.

The government has increased infrastructure spending and institutionalized the conditional cash transfer program, among others, both of which will allow for inclusive and sustainable development.

Some P89.4 billion was allocated for the CCT program in 2018 alone, and the budget accounted for about 0.5 percent of domestic output.

The program has benefited over four million families or about 21 percent of the country’s population.

These programs, backed by the country’s strong macroeconomic fundamentals and further enhanced by game-changing reforms will help the country endure its marathon towards inclusive and sustainable development. The Philippines, clearly, will not be the “laggard in Asia” in this respect.

Before the pandemic, the economy had been posting above six percent annual output and economic managers aimed to elevate the economy to upper middle-income status by 2022.

However, the pandemic happened and growth, as measured by gross domestic product , contracted by 8.3 percent in 2020.

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