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Saturday, November 23, 2024

FDA feels the heat from Church group

There’s big money to be earned in the manufacture and distribution of contraceptives in the Philippines. For the religious and conservative sector, the stakes are higher when moral choices are pitted against any form of birth control.

The Food and Drugs Administration is forced do a balancing act to please both the prospective distributors of contraceptives in the Philippines following the enactment of the Reproductive Health Law, and their critics, presumably with the blessings of the powerful Church.

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A non-governmental organization, which appears to have the backing of the Roman Catholic Church, is going all-out to cast doubt on the technical review being done by the Food and Drugs Administration on two contraceptives.

The FDA reevaluation of Implanon and Implanon NXT are being carried out in line with a Supreme Court resolution stopping the distribution of the two products until the agency have re-certified that they do not cause nor induce abortion. The SC issued the restraining order in response to the petition of a group calling itself the Alliance for the Family Philippines Inc.

The group seems to be a political and influential one. Its leadership, according to its website, includes prominent names in Metro Manila’s circle of elite families.

The group espouses the same advocacies that are currently championed by the  Catholic Church—the war against homosexuality, same-sex marriage, divorce and others. Its president is a lady lawyer known for backing business interests that deal with regulatory authorities, especially the Energy Regulatory Commission.

The group’s headquarters is located in the enclave of Metro Manila’s wealthy families—Alabang. This sends signals to the FDA that the group has the wherewithal to carry out a long battle to permanently stop the government from distributing the two contraceptive products in question.

The Supreme Court’s restraining order attests to the influence that ALFI has. Based on its posts in its website, the group has recruited a former SC justice in its bid to derail the FDA re-certification process. Securing a TRO from the High Court alone is an initial indication of the group’s political mettle.

US-certified

The two controversial contraceptives, meanwhile,  have already been certified safe by the US government. The US FDA has one of the most rigid processes and standards in the world. Its methods and the certifications it issues for food and drug products are under perpetual scrutiny by the public and interest groups in the US.

It may be reasonable to presume that the two contraceptives have passed through the eye of the needle when its manufacturer applied for product certification from the US FDA. We are not sure if these facts were made known to the SC when the petition to stop the two contraceptives were filed. If the High Court did, credit should be given to the ALFI for convincing the court to ignore established facts and adopt a position different from what other countries in the world had.

FDA led by director-general Nela Charade Puno should realize that her agency is up against a group that is wealthy and has the backing of the country’s top moral authority, the Church. It also has brilliant legal minds that know exactly how to bring the SC to its side.

ALFI claimed that the FDA has not been transparent in the conduct of the re-certification process for the two contraceptives in question.

Observers noted that ALFI wants to bring the issue away from the realm of science and into the arena of a legal-political debate. “We hope the sober voice of science is not drowned in the din of emotions triggered by political debates,” one industry observer said. 

Given the credentials of ALFI’s front-liners, one would doubt if the FDA could generate much support for the science-based truth. Puno should also be warned that the current vilification efforts against the agency would invite so-called “piggy-backers.”

Sources say Puno is in the cross hairs of a multinational company that prominently figured when the Cheaper Medicines Act of 2008 was still being deliberated in Congress. This powerful interest is reportedly piqued by moves initiated by the Department of Health to trigger the inclusion of more drug products in the list of medicines covered by the Cheaper Medicines Law.

Pharmaceutical sources say the same group also lobbied heavily against Health Secretary Paulyn Jean Ubial, who was rejected by the Commission on Appointments Tuesday. There are concerns that this interest may use the debate on the re-certification of the two contraceptives to get back at the FDA and neutralize the DoH. Puno’s battle and that of the FDA have just begun. 

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