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Make it inclusive, transparent, FDA

A judge must apply the law as written. Judges are not policymakers,Judge and Law Prof. Amy Coney Barrett, President Trump’s appointee to the US Supreme Court

The role of the Food and Drug Administration is not only regulatory.

Its job is not limited to enforcement of food and drug safety laws.

It also has quasi-judicial or adjudicatory functions – it holds hearings on applications for clearance on key consumer products before they can be legally released and sold in the market.

But executing the twin missions is no joke; it is not a laughing matter.

It is a serious business, a delicate high-wire balancing act.

An agency vested with such vast powers must answer to three principals – the government it represents, the industry it regulates, and the general public who either enjoys or endures the consequences of its decisions.

The conduct of its official actions must at all times reflect governance at its best, uphold and protect the interest — health, safety, and welfare — of the public, and hold business and industry to account for goods made and sold.

Failing these, a regulatory agency fritters away its reason for being, and its officials and personnel must be made to answer to society.

Therefore, equity, fairness, and fidelity to its mandate must always guide its actions.

These, in turn, require “inclusive, participatory, and transparent” processes or proceedings.

The abuse of regulatory fiat is most glaring in such bodies mounting rigged hearings.

Thus, Ped Xing can understand the exasperation and outrage of consumers and tobacco harm-reduction advocates in denouncing the FDA for holding what they called “poorly-choreographed” public hearings on draft guidelines for e-cigarettes and heated tobacco products without listening to the voice of the stakeholders and the public.

The reported moro-moro hearing came in the wake of allegations the FDA received foreign funding from anti-tobacco groups, prompting the House leadership to call for an investigation on the agency’s potential conflict of interest and bias.

“We urge the FDA to listen to and respect the rights of 16 million Filipino smokers who deserve better alternatives to combustible cigarettes,” said Clarisse Virgino, the Philippine representative to the Coalition of Asia Pacific Tobacco Harm Reduction Advocates — a regional alliance of consumer THR advocacy organizations.

“The supposed consultations held by FDA on October 6 and October 8 on vapor products and heated tobacco products, respectively, turned out to be one-sided, pre-recorded lectures with cherry-picked questions that ignored the concerns of vapers, skipped scientific evidence, and violated the rights of consumers to be heard,” Virgino said in a statement.

Peter Paul Dator of Vapers PH said the FDA should have included the inputs from consumers and stakeholders who would be directly affected by the draft guidelines.

“All we ask for are transparency and inclusion in the discussion because we—the consumers—are the ones directly affected by these guidelines, and not the pharmaceutical or medical groups who have no stake in the issue. We hope that in the next dialogues, if there are any, the FDA officials will open their minds, listen to scientific evidence, and do their job of regulating, and not restricting the use of these novel products, as our existing laws intended,” Dator said.

He said the imposed limitations during the public consultation made it challenging to discuss extensively and thoroughly the crucial provisions of the proposed guidelines.

“In coming up with a regulation that has the potential to positively change the lives of 16 million Filipino smokers, we, the stakeholders were expecting a more transparent and participatory process,” he added.

The FDA recently conducted two public hearings attended by some members of Congress as it prepares the guidelines for the regulation of vapor products and HTPs which the Royal College of Physicians, Public Health England and the National Academies of Science, Engineering and Medicine recognize as presenting reduced risks because they don’t employ the traditional cigarette combustion process that releases 7,000 chemicals.

On questioning from Nueva Ecija Rep. Estrellita Suansing, the agency admitted receiving money from international anti-tobacco groups –The Union and Bloomberg Initiative — raising concerns on its independence and potential conflict of interest.

Deputy Speaker and Ilocos Sur Rep. Deogracias Victor Savellano said he would file a House resolution calling for a full-blown congressional investigation.

Behold God’s glory and seek His mercy.

Pause and pray, people

Publication Source :    People's Journal