FDA ramps up ‘regulatory muscle’ vs fake products

FDA ramps up ‘regulatory muscle’ vs fake products

The Food and Drug Administration, the agency tasked with ensuring the safety, efficacy and quality of food, drugs, cosmetics, medical devices and health products being used by the Filipino public, is ramping up its regulatory muscle, said FDA director general Nela Charade G. Puno.

Since August 2016 up to mid-August 2017, Puno said its Regulatory Enforcement Unit has seized over P4.3 million worth of unregistered and fake drugs and medicines, cosmetics, medical devices and violative hazardous urban household substances products.

“Noteworthy is the strengthening of FDA’s regulatory enforcement capabilities that received a boost with its partnership with the Philippine National Police [PNP] in Task Force D-PUNCH which stands for Destroy Products Unfit for the Consumption of Humans,” said Puno.

She pointed out that FDA and PNP are one in the goal to minimize, if not eradicate counterfeit, unregistered, adulterated and misbranded health products in the market that pose danger to life, health and safety of the public.

The REU has provided service of legal orders such as Summons and Cease and Desist Orders, surveillance/investigation, assistance to FDA regional field offices and other law enforcement agencies, the Department of Health, and Service of Search Warrants.

It has also padlocked some 29 establishments that are operating without license and selling products without the required certificates of product registration.

As a result of Joint Entrapment Operations and Implementation of Search Warrant with the PNP- CIDG in Region 4A and NCR, the FDA has seized and confiscated violative HUHS products confiscated in Rizal and Manila.

The total number of suspects arrested in the joint Entrapment Operation with PNP CIDG are 13, with Criminal Cases referred to the Prosecutors Office.

She also made an assurance to strike a balance between the protection of consumer safety and supporting ease of doing business with partners in the industries that FDA regulates.

“We will accomplish this while following President Duterte’s three marching orders of zero backlog, 72 hours turnaround time and strengthened enforcement,” Puno said.

Puno reported the FDA has already posted a 33 percent  reduction in all accounted backlogs as of July 31.

“We are committed to reduce our backlogs in applications for license to operate [LTO], Certificate of Product Registration [CPR]and legal decisions by 90 percent by the end of this year.” she said.

Mechanisms are also being put in place to ensure 72-hour turnaround time in response to inquiries, requests and other transactions in the FDA.

The recent transfer of the Food and Drug Action Center while the facilities in the main office are being modernized is also expected to further speed up response and turnaround time for FDA services to its stakeholders and the public.

Puno also emphasized the need to fill up plantilla positions so as to have the much needed manpower for its plans and programs.

Another milestone is the finalization of the amended Rules of Procedure/Guidelines for the certification and re-certification of all contraceptive products. She added that the FDA is set to hold the first round of summary hearings under the amended procedure starting week of August 21, 2017.

FDA will fast-track the hearings and decide applications involving contraceptive products, so this case can be resolved soonest.

Meanwhile, Puno points out that the future of FDA is clearly mapped out, anchored in innovation, with the Submission and Approval of its 5 Year Development Plan. “We are the only agency under the Office of Health Regulation of DoH which was able to do this,” she said.

Phase 1 from 2017-2019 is to Restructure the Agency’s Foundation. Phase 2 from 2020-2021 covers New Strategies to accelerate growth. Phase 1 includes establishing a strong management information system and operational system, which means modernizing FDA’s information technology system.

“We will undertake organizational reform and development. Strengthen our inspection and enforcement actions. Upgrade our facilities and tools. Improve our policies by creating and implementing smart regulations. Strengthen our public information delivery and services,” Puno said.

Under this, the FDA is developing IT innovations for the benefit of the public and stakeholders. It is also set to unveil soon a mobile application that will allow the public to check the status of food, medicines, cosmetics, medical devices and health products. A teaser for the app is shown at the FDA REGULATORY FAIR on Aug. 17-18.

Under Phase 2, the objective is to introduce new strategies to expand and accelerate growth, which includes enhancing and entering new inter-agency partnerships.

Puno said this will prepare FDA and stakeholders for globalization. “

“We have to start our digital enforcement activities, improve our laboratory capabilities and improve the FDA Academy service portfolio.”

“All these are in the pipeline as the FDA works in its 54th year to achieve our vision to become an internationally recognized Center of Excellence in health product regulation by 2026.” Puno said.


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