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FDA admits getting over $150,000 from anti-tobacco NGO to regulate vapes

Top officials of the Food and Drug Administration, which is in charge of drafting the regulations on e-cigarettes and heated tobacco products, confirmed in a congressional investigation on Tuesday that they solicited and received money from a foreign anti-tobacco organization funded by Bloomberg Philanthropies, the charity of American billionaire Michael Bloomberg.

FDA director-general Rolando Enrique Domingo told the House Committee on Good Government and Public Accountability chaired by Rep. Michael Edgar Aglipay that the regulatory agency applied for and received a grant of $150,430 from the International Union Against Tuberculosis and Lung Disease (The Union) in 2016 mainly to hire “job order” employees who would draft the tobacco control policies of the agency.

The Union manages the Bloomberg Initiative to Reduce Tobacco Use Grants Program, a campaign that is dedicated to tobacco and vaping control policies.

“We worked with the World Health Organization, the Asian Development Bank, and non-government organizations such as the International Union Against Tuberculosis and Lung Disease (The Union). The Union is a part of the Bloomberg Initiative grants program,” Domingo said during the hearing which was convened to discuss House Resolution 1396 filed by Deputy Speaker Rep. Deogracias Savellano and Nueva Ecija Rep. Estrellita Suansing to shed light on the receipt of private funding by the FDA and other government agencies and institutions.

The FDA said that in February 2017, a grant was given by The Union for the project titled “Strengthening the Regulatory Systems on Tobacco Control under the Food and Drug Administration”.

“This was way in 2017 before the present laws have been passed,” Domingo said, referring to Republic Act No. 11347, RA 11467, Executive Order No. 106 and Joint Memorandum Circular No. 003-2020 which allow but regulate the sale, distribution and taxation of vapor and HTPs in the Philippines.

The FDA then issued Administrative Order No. 2020-0055 for the regulation of vapor products and HTPs on December 1, 2020, with effectivity date of January 14, 2021 and full enforcement on May 24, 2022.

Savellano said it was apparent that the regulations of the FDA were even more restrictive than the regulations for cigarettes resulting in a de-facto ban on electronic nicotine delivery systems or e-cigarettes and HTPs. “Considering the substantial funding given to the FDA by these organizations, I personally was not surprised by the policy direction. We learned that other agencies are also receiving funding. The DOH received grants from Bloomberg from 2010 to 2012,” Savellano said.

House Deputy Speaker Rufus Rodriguez agreed that Constitutional provisions may have been violated in soliciting and receiving money from The Union.

“How can you be able to dispense objective and unbiased judgement on this regulation when you are a recipient of Bloomberg which has a position on absolute ban?” Rodriguez said.

“This is what is happening now.  You [FDA] were funded by Bloomberg and the Union and the stand of the Union is against tobacco,” Suansing said.

“I called for this investigation to find out the truth.  We hope we can better defend our independence and sovereignty so that we cannot become an easy target of foreign private entities,” Savellano said.

Domingo said that under the Bloomberg-funded project, the FDA received a grant amount of $150,430 while the government’s co-funding requirement was $335,864.  He said the grant was used to hire manpower support in the implementation of the National Tobacco Control Program (NTCP), enable the FDA activities for the development of regulatory guidelines and the implementation of existing regulations, enable the FDA to develop and implement necessary regulatory system for the implementation of existing laws and regulations, and capacitate the FDA-Field Regulatory Operations Office.

Domingo said the FDA used P5.26 million under the grant until 2020, while the balance of P1.6 million was already returned to the Union.

“The grant was completed in 2020. About P3.5 million was used for staffing. We used it to hire ‘job order’ employees, while the operational cost amounted to P1.4 million,” he said.

Domingo, however, denied that the FDA was influenced by The Union on its policy direction. “I assure that all our guidelines are crafted objectively. I have never met with representatives of The Union.  I don’t remember meeting them in 2020 or 2021,” said Domingo, who was transferred to the FDA from the DOH in March 2020. “We always pattern our regulation within the existing laws.”

Domingo said that under Republic Act No. 9711, the FDA is allowed to accept foreign grants, donations and all other endowments as long as they follow pertinent rules and regulations.

FDA’s Center for Cosmetics Regulation and Research Director Ana Trinidad Rivera said the release of the grant was based on the terms of reference that the FDA developed.

Rivera said the FDA applied for The Union grant way back in 2015. “At that time in 2016, we only had 26 plantilla personnel and it will be an additional task for us,” said Rivera who moved to the FDA from DOH in 2016.

“At that time, there was also no regulatory framework that the FDA can benchmark with.  So we needed a lot of researches, and the researches are very dynamic.  And we need additional staff at that time.  The reason why we requested or submitted a proposal to the WHO initially, and to the other development partners of the Department of Health,” said Rivera.

Suansing said the FDA should have requested additional budget from the government, instead of approaching foreign private organizations such as The Union which might influence the crafting of the FDA guidelines.

Domingo said the situation in 2016 was also different.  “There were no laws yet on these.  At that time, the FDA had very limited budget.  Although at this time, we already have a bigger income,” he said.

Suansing said she plans to file a bill to prevent government agencies from receiving grants from foreign private groups which advance their own interests in the country.  “My objective is to come up with a bill not to allow the FDA to accept grants and funds from local or external sources that will influence their decision-making in coming up with the guidelines,” she said.

Topics: Food and Drug Administration , e-cigarettes , Michael Bloomberg , Rolando Enrique Domingo
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