Solon slams ‘premature’ FDA issuance of e-cig, HTP regulation

Nueva Ecija Rep. Estrellita Suansing (Photo courtesy by MB)

MANILA — A lawmaker has deplored what she called “premature” issuance of regulations on vapor products and heated tobacco products (HTPs) by the Philippines Food and Drug Administration (FDA) which failed to conclude public consultations on the issue amid its acceptance of grants from foreign anti-tobacco organizations.

Nueva Ecija Rep. Estrellita Suansing said the issuance of Administrative Order No. 2020-0055 by the FDA was unexpected and “deplorable,” as the agency had not completed the public consultations on the guidelines for the regulation of vapor products or e-cigarettes and HTPs.

The AO was signed by the FDA on December 1, 2020 but was only made available on its website on January 4, 2021. Rep. Suansing said the AO was issued despite the fact that there was no formal notice of termination of the public consultation and the call for a Congressional investigation on FDA’s receipt of foreign funds.

“It is premature and clearly done in bad faith”, she said. “Despite the unfinished public consultation on the FDA’s draft guidelines and numerous unresolved matters raised by legislators and stakeholders alike, prompting all three lawmakers present to call for more hearings, the FDA, through the Department of Health, still proceeded to issue their regulations, without any prior notice or resolution. For whatever reason, it’s as if the valid concerns raised were deliberately ignored.”

The FDA conducted public consultations on October 6 and 8, 2020 on its draft guidelines on the regulation of vapor products and HTPs, respectively.

The hearing on HTPs, attended by Rep. Suansing, Ilocos Sur Rep. Deogracias “DV” Savellano, and Valenzuela Rep. Wes Gatchalian, was however cut short after FDA officials refused to answer Rep. Suansing’s question on FDA’s receipt of private funding intended to implement anti-tobacco and anti-vaping policies from international private groups.
An FDA official initially denied receiving foreign funds but when confronted with actual donor declarations from Bloomberg’s official website by Rep. Suansing, officials had no choice but to admit receiving such grant.

“I tried to pursue the question about the foreign grants but an official said that he was ordered not to answer me. He said FDA leadership will instead coordinate with my office to discuss the grants separately. With this stubborn refusal, I could not allow the so-called consultation to proceed given the potential conflict of interest. Arguably, these foreign grants could have pushed the policy direction of the FDA in drafting these regulations,” Rep. Suansing said.

“In addition to receiving funds from the Bloomberg Initiative, the FDA also admitted to soliciting and accepting funding from another anti-tobacco and anti-vaping organization, The International Union Against Tuberculosis and Lung Disease (The Union). If so, how then can the public put faith in the integrity of these consultations when the government regulator itself has admitted to receiving funding from groups that seek to ban the products the regulator should be regulating,” she said.

She said that instead of allowing local policies to be influenced by foreign vested interest groups, regulators should look into the actual experience of other countries such as the United Kingdom.

“Take the case of Thailand and the United Kingdom for example. Each has taken a different approach in tobacco regulation with the former implementing a prohibitive stance on smoking alternatives, while the latter embracing tobacco harm reduction principles. The rate of smoking in the UK has been steadily decreasing in contrast to Thailand where smoking rates remain stagnant,” Rep. Suansing said, referring to the conclusion of a policy study done last year by R Street Institute—a nonprofit, nonpartisan, public policy research organization.

On December 2, 2020, Rep. Suansing and Rep. Savellano filed House Resolution No. 1396, directing the House Committee on Good Government and Public Accountability with the specific intent to conduct an inquiry on the questionable receipt of private funding by the FDA and other government agencies and institutions in exchange for specific and pre-defined policies directed against a legitimate industry and in complete disregard of the rights and welfare of consumers.

Rep. Suansing said, “the resolution was filed in order to ensure the integrity of government proceedings and reaffirm the public’s trust in our government regulators.”

“The initial denial and subsequent admission bring into question the objectivity, impartiality, and credibility of the FDA in drafting these Guidelines and overseeing the implementation of these regulations. The potential conflict of interest these foreign funds creates cannot be ignored and must first be resolved in order to preserve the integrity of the proceedings,” the resolution stated.

“We cannot allow this critical inquiry on funding to be swept under the rug. The crafting of public policy should not be influenced by the highest bidder. We will make sure that our policies and proceedings are free from any conflict of interest or foreign influence. This premature issuance of A.O. No. 2020-055 by the FDA has given us more reason to pursue the investigation,” Rep. Suansing said.

The resolution seeks an investigation on the manner by which the FDA public consultations were conducted and how these private funds could have influenced it, to the detriment of good regulatory practice, the credibility of Philippine government institutions, and the lives and livelihoods of consumers, citizens, businesses and stakeholders. (AI/MTVN)