Congress to probe FDA on e-cigarette and HTP regulation

A lawmaker vowed to pursue an investigation into the Food and Drug Administration’s alleged conflict of interest following what she described as “premature” issuance of regulations on vapor products and heated tobacco products without concluding meaningful public consultations and answering questions on its acceptance of foreign grants from lobby groups.

Nueva Ecija Rep. Estrellita Suansing deplored the issuance of Administrative Order No. 2020-0055 by the FDA, saying the agency had not yet completed the public consultations on the guidelines for the regulation of vapor products or e-cigarettes and HTPs. She said the FDA also failed to explain its side on allegations the agency received foreign grants from foreign anti-tobacco organizations.

The FDA signed the AO on Dec. 1, 2020 and made it available on its website on Jan. 4, 2021.

“It is premature and clearly done in bad faith,” Suansing 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 Oct. 6 and 8, 2020 on its draft guidelines on the regulation of vapor products and HTPs, respectively.

The hearing on HTPs, attended by Suansing, Ilocos Sur Rep. Deogracias Savellano and Valenzuela Rep. Wes Gatchalian, was cut short after FDA officials refused to answer Suansing’s question on FDA’s receipt of private funding intended to implement anti-tobacco and anti-vaping polices 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,” said Suansing

“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.

Although the FDA public consultation has not resumed, AO 2020-0055, which provides the FDA’s regulatory framework for the manufacture, distribution, importation, exportation, sale, offering for sale, advertising, promotion, sponsorship, and/or use of vapor products and HTPs, was released and posted on the FDA website on Jan. 4, 2021.

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,” Suansing said, referring to the conclusion of a policy study done last year by R Street Institute—a nonprofit, nonpartisan, public policy research organization.

Suansing and Savellano filed House Resolution No. 1396 on Dec. 2, 2020, 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.

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,” 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 the same, to the detriment of good regulatory practice, the credibility of Philippine government institutions, and the lives and livelihoods of consumers, citizens, businesses and stakeholders.

Topics: Food and Drug Administration , tobacco products , Estrellita Suansing
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