FDA cites Duque’s role in approval of contraceptives

The Food and Drug Administration (FDA) recently lauded the “valuable role” played by newly appointed Health Secretary Francisco Duque in the “timely conclusion of the recertification of the 51 contraceptive products ordered reviewed by the Supreme Court (SC).”

In a media briefing recently, FDA DirectorGeneral Nela Charade Puno said “Secretary Duque’s acceptance of the health portfolio was well-timed and was a blessing to the FDA.”

“In more ways than one, Secretary Duque’s guidance to, as well as his confidence and trust in, the processes and procedures of the FDA, proved to be very valuable as the reevaluation and recertification process came to the homestretch,” Puno explained.

The FDA head had earlier hinted that the agency was “under pressure” from various quarters as it reviewed and reevaluated the contraceptive products to ensure that these are safe and non-abortifacient as direct by the SC.

“Secretary Duque provided that assurance that the results of the FDA review will stand the scrutiny both of its stakeholders and critics because the review is based on a scientific and technical process,” Puno said. “That assurance boosted our confidence in the integrity of both the process and its results,” Puno added.

Duque had publicly called on “all public health officials to defer to the technical expertise of regulatory agencies like the FDA.” “In a way, it was Secretary Duque who rallied valuable support for the FDA during the critical period of the review process,” Puno said.

“The esteem with which Secretary Duque is held in the health sector and his firm grasp to reproductive health issues and requirements benefited the FDA immensely during that time,” Puno said.In the same briefing, Puno explained that the FDA based its recommendation to recertify the 51 contraceptive products on the technical evaluation done by two groups. She said the FDA had formed its own technical working group (TWG) composed of organic scientists and researchers. It also formed an independent “Expert Review Group” (ERG) to conduct its own parallel reevaluation of the said products.

“The FDA made sure that its findings are validated by an independent group of highly respected professionals,” Puno explained. “This assures the public that the recertified products can be used safely and that they do not have to worry that these may cause unintended abortion,” she added.

Puno said the ERG was made up of obstetricians and gynecologists who are mostly in private medical practice. They were selected based on a strict criteria which included requirements for advanced medical studies, experience in the practice, and certification by their respective professional associations, Puno explained.