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Friday, March 29, 2024

Food and drug body gives teeth to RH law

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The controversial reproductive health law has finally hurdled its vocal critics and the Supreme Court, thanks to the science community and the new leadership at the Food and Drugs Administration.

The FDA has just finished the recertification of some 51 contraceptive products ordered for review by the Supreme Court. Reevaluating the contraceptives was fraught with public debates, triggered by the stinging remarks made by President Rodgrigo Duterte during his last State of the Nation Address against SC Chief Justice Lourdes Sereno.

Duterte in his SONA accused Sereno of causing a serious delay in the implementation of the RH Program. He publicly called on Sereno to lift the temporary restraining order the High Court issued against the further certification and distribution of contraceptives by the Department of Health.

The TRO caused the program to languish in limbo for a good two years. Duterte’s call compelled Sereno to clarify that the TRO could be automatically lifted as soon as the FDA reevaluated the contraceptives concerned and issued a new certification attesting to their safety and that they did not induce unintended abortion.

The new FDA head, Director-General Nela Charade Puno, immediately embarked on the recertification process. The move appeared to have stirred the proverbial hornet’s nest, and agitated several groups that have long opposed the RH program. Critics soon trained their guns on Puno, who they thought was vulnerable being young and new in the government, and with no political clout.

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These groups, mostly Church-backed, underestimated Puno. The new FDA head knew how to protect her back and make sure the the results of the recertification process was above suspicion. She quietly formed a second group to do a parallel technical reevaluation of the 51 contraceptives.

Puno tasked an “Expert Review Group” to check and validate the review done by FDA’s own group of scientists and researchers. She carefully vetted several medical practitioners who are respected by their peers and certified members of their respective medical associations. These doctors are specialists in the fields of obstetrics and gynecology.

The tack proved to be a bold stroke. Anyone who questions the results of the recertification process will have to attack the integrity and competence of the doctors who composed the ERG. They will have claim that these medical practitioners are corrupt or simply ignorant.

Medical profession in charge

The accusers will have to say that the fellow doctors of the ERG members erred in giving the latter their respect and recognition as outstanding medical practitioners and academicians. In the end, the accusers will have to wage war against the entire medical profession and community of doctors.

The only way the bashers of FDA’s Puno can win in the fight is to assemble a similar group of experts who can dispute the results of the ERG’s work. They will have to do this using solid medical and scientific evidence.

Puno’s critics are mostly lawyers and moralists, instead of doctors and scientists. And Puno made sure that the recertification process remained within the realm of science and medicine, and beyond the reach of the hysterics of politics.

The recertification process will simply answer just one question: are the contraceptives safe and non-abortifacient as they claimed to be? This is a question best answered by using the sober and methodical tools of science. Scientific evidence is required here–not political or moral arguments.

The recertification process helped the country’s stalled RH program to get back on track. It is plain and simple a triumph of science over political hysteria. It also proved that it pays to have a scientist at the helm of the FDA.

Meanwhile, Puno may have created more enemies in addition to the Church-backed anti-reproductive health groups. She appeared to have disturbed several powerful business interests after pushing for stronger law enforcement operations by the FDA. Just recently, the FDA Regulatory Enforcement Unit led by former Police Chief Superintendent Allen Bantolo raided and shut down a pharmacy in Cebu manufacturing counterfeit products and the Duty-Free Fiesta Mall outlet, which reportedly sold food items that are almost expired.

Puno should watch out. The big business interests behind these products will not take their losses sitting down and could get back at her.

E-mail: rayenano@yahoo.com or business@manilastandard.com.ph or extrastory2000@gmail.com

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