Solon calls out FDA for ‘premature’ issuance of regulations governing vapor products

Nueva Ecija Rep. Estrellita Suansing says the issuance of Administrative Order No. 2020-
0055  by the FDA was “unexpected and deplorable.” (Photo from her office)

MANILA, Philippines — Nueva Ecija Rep. Estrellita Suansing called out the Food and Drug Administration (FDA) on Wednesday for what she called the “premature” issuance of regulations governing vapor products and heated tobacco products (HTPs) as public consultations on the matter had not even been completed.

According to Suansing, the FDA issued Administrative Order No. 2020-0055, which was signed on Dec. 1, 2020, but was only posted on its website last Jan. 4.

“It is premature and clearly done in bad faith,” Suansing said in a statement. “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.”

She was referring to grants that the FDA got from anti-tobacco organizations — namely, Bloomberg Initiative and the International Union Against Tuberculosis and Lung Disease (The Union).

Suansing added that the order was issued despite the lack of a formal notice of termination of the public consultation and the call for a congressional investigation into FDA’s receipt of foreign funds.

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

Suansing attended the hearings, as did Ilocos Sur Rep. Deogracias “DV” Savellano and Valenzuela Rep. Weslie Gatchalian.

The hearings were cut short when FDA officials refused to answer Suansing’s question on the foreign grants.

“I tried to pursue the question about the foreign grants but an official said that he was ordered not to answer me,” Suansing said. “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.”

According to Suansing, the FDA admitted during the hearings to “soliciting and accepting funding” from the two foreign organizations.

“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 Thailand and the United Kingdom.

“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,” she said.

“The rate of smoking in the UK has been steadily decreasing in contrast to Thailand where smoking rates remain stagnant,” Suansing added, citing the conclusion of a policy study done last year by R Street Institute, a nonprofit, nonpartisan, public policy research organization.

On Dec.  2, 2020, Suansing and Savellano filed House Resolution No. 1396, directing the House Committee on Good Government and Public Accountability 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.”

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

“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,” Suansing said. “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.”