ARTA prods FDA on mounting backlogs

September 3, 2019 at 16:00

Bernie Cahiles-Magkilat | Manila Bulletin | September 3, 2019

The Anti Red Tape Authority (ARTA) will order the Food and Drug Administration (FDA) to implement the automatic renewal of applications as soon as possible to declog the mounting number of applications and streamline their processes to effect an efficient approval system.

Director-General Jeremiah Belgica told reporters that if he had his way he would like an “immediate” implementation of the approval system on the 2,083 pending applications for automatic renewal for drugs. Belgica, who conducted a surprise inspection at the FDA last week, called the agency officials yesterday to a meeting to explain amid complaints from at least 30 groups against the inefficiency of the FDA in the processing of their applications and the mounting backlogs.

“I am for automatic renewal and if it is for automatic renewal it should be automatically approved already,” he said stressing that under the ARTA Law, applications for automatic renewal should fall under the “simple” category of government transactions, which are supposed to be released within three days only. The 2,083 applications for automatic renewal or classified as low risk applications and account for the bulk of the backlogs.

“They just have to remove unnecessary rules and at the same time not impairing public health and safety,” he said

adding that even if these applications are approved but the internal system is still the same there would still be backlogs in the future.

The FDA Center for Drugs, which processes applications for drugs and medicines, provides for an automatic renewal of applications but this has not been the case. Aside from drugs, FDA has centers for cosmetics, food and devices that will issue permits or licenses before these products are launched in the local market.

FDA provides for automatic renewal applications, but this has not been the case because the director in a particular center would still review the application even if it is for automatic renewal, fees are completed and has already submitted the affidavit of undertaking that there were no changes in the product.

Belgica explained that the affidavit of undertaking already bound the applicant to the truthfulness in his application. So, if the product is found to have changes later on in the post monitoring conducted by the FDA then the company is held criminally liable for committing perjury and must be banned from conducting the business.

The problem is there have been unscrupulous applicants also who are not truthful, but he also said that as much as 95 percent of these applicants are good and true to their declarations.

To facilitate the process on at least the pending applications, Belgica suggested that all those applications for automatic renewal are notified to remove their documents if they had not been truthful in their declaration so the FDA can start with the immediate automatic approval. If there are changes in the product, then the applicant has to file for a new application.

“So, we also give an obligation to the applicants to be truthful in their application,” he said.

There are two things that ARTA would like FDA to implement: Automate their processes and rationalize their processes and regulations.

On drugs alone, they received 8,976 applications for this year alone and already processed close to 8,000 applications, making the center is at least on track to meet its completion by end this year. But what is holding them is the mounting backlogs that have accumulate since 2015 yet.

So far, there are pending 14,693 applications and roughly 9,000 in line for evaluation. Overall, there are 17,2014 at the drugs center attended to by a lean staff 14 for licensing and 44 on the registration side.

The FDA Center of Food said at the meeting that they also encountered delays as they are now migrating to automated processes from manual processing. The center for food has total pending applications of 11,959 with only 12 evaluators and 5 checkers.

To this, Belgica suggested that government agencies should consult with the Department of ICT to avoid “burning the house to catch the rat.”

Belgica also noted that the issue of lacking of personnel can no longer be used as an excuse for these long delays because that has been a problem in all government agencies. But he found out that in the case of the FDA, the evaluators of the automatic renewal applications are not necessarily chemists because they are just doing a comparison from the previous approval.

As far as Belgica is concerned, the delays at the FDA processes are not intentional but the anti red tape czar did not also absolve FDA.

“I think it is not intentional, but I would not absolve anyone yet. Nobody’s off the hook at this time,” he said.

FDA Deputy Director General Ronald de Veyra said they will comply with the ARTA Law’s 3-7-20- (simple, complex, and highly technical) day allowance to approve or disapprove permits and government licensing. They are also in the process of harmonizing their Citizens’ Charter to ensure a uniform set of requirements for applicants.

He explained their four centers on food, drugs, cosmetics and devices have different timelines. For instance, the drugs center has 2 to 3 years approval lag time. Others have 120-day processing period.

Source: https://www.pressreader.com/philippines/manila-bulletin/20190903/281543702601374