FDA foes failed to do their job


Whatever happened to the much-vaunted opposition to the recertification of some 51 contraceptive products covered by a Supreme Court (SC) temporary restraining order (TRO)?

The Food and Drugs Administration (FDA) recently released the results of its technical reevaluation of the contraceptives that it recertified as safe and nonabortifacient. With the FDA recertification, the TRO was automatically lifted, allowing the Department of Health to purchase and distribute them in health centers nationwide.

While this is a welcome development, many think  that the groups supposed to stop the FDA from recertifying them have failed to do their job.

At the forefront of the pressure on the FDA was the powerful, Church-backed group Alliance for the Family Philippines Inc. (Alfi), which questioned the safety of some of the contraceptives and alleged that they may actually induce or cause unintended abortion. Alfi got the SC to slap the Reproductive Health (RH) Act with a TRO and stalled its implementation for a good two years.

It is clear that the SC was not in a position to rule on whether the contraceptives questioned by Alfi were abortion-inducing. The SC justices chose not to pretend that they had the scientific and technical competence to make a judgment on a matter that belongs to the realm of medicine and pharmacology.

So, it was clear even to the SC that the matter that should be resolved is that of the safety of the products in question and the certainty that they would not induce unintended abortion. Many had hoped that Alfi would try and prove its point that the contraceptives it questioned at the SC are abortifacient once the FDA begins the review process.

That was not what happened. Based on a revelation made by FDA Director General Nela Charade Puno, the agency gave all parties concerned a window, during which they were made to submit new evidence and present experts to prove their respective position on the contraceptives in question.

Puno disclosed that Alfi had previously said it would present two expert witnesses. However, Alfi broke its promise. The presentation of the supposed “expert witnesses” who could prove that some of the contraceptives in the review list may induce abortion never materialized.

According to Puno, all that Alfi did during the review process was to  question the legality of the FDA review process and its procedures. We can only speculate on the possible reasons Alfi failed to deliver its “experts.” One, it did not really have credible experts who could challenge the scientists and doctors tasked by the FDA to do the reevaluation. Two, Alfi knew all along that the contraceptives in question are safe and that it merely intended to derail the government’s RH program to kowtow to the wishes of the powerful Catholic Church.

The speculations appear to have strong basis. After all, if Alfi had solid proof and authentic experts to challenge the safety of the contraceptives in question, the group would have faced the issues head-on. It did not have to resort to pressuring FDA’s Puno and accusing her of “lacking in transparency.”

To the credit of Puno and the FDA, the public is convinced of the integrity of the results of its review and recertification. Puno formed two separate groups to conduct the technical reevaluation of the contraceptives. One group was composed of the FDA’s resident scientist-researchers. The other was an  independent group of gynecologists and obstetricians certified by their organizations and highly respected by their peers.

Puno and the FDA have done a good job. Puno brought the RH program back on track and battled intense pressure from various quarters that wanted to unduly influence the results of the technical review. Puno’s job was to come up with a credible technical review based on scientific methods and evidence.

Alfi’s job was to disprove her findings. That can only be done by tapping experts who are more credible than the groups put together by FDA’s Puno for this task. That is the job that Alfi failed to do. For this,  the group cannot pass on the blame to FDA’s Puno.

Anti-poor tax

The latest development in the Senate regarding the bill seeking to impose higher taxes on sugar-sweetened beverages (SSB) is the proposal to slap an average of P5 for every liter of soda, iced tea and ready-to-drink juice. This would translate into the following increases: soda, from P16 to P21 per liter; powdered juice and iced tea, from P9 to P14 per 1-liter sachet; for ready-to-drink juice, from P20 to P25 per liter.

Sen. Ralph G. Recto has described the SSB tax as the most controversial provision of the Tax Reform for Acceleration and Inclusion (TRAIN) bill, as it would hurt sari-sari stores and D and E consumers who consume these products the most.

“We are going to hit the consumers, especially the poor, who will not benefit from the tax reduction to begin with. We are going to hit them with P280 billion of consumption tax,” Recto said.

Aside from the sweet tax, the TRAIN bill will also affect other consumer prices, such as fuel and utilities. The proposed SSB tax, if passed, would  be among the highest rates in the world. Consumer prices will drastically increase, beginning January 1, 2018. The inflation rate would no doubt shoot up once the TRAIN bill is passed, exacerbating the already tough daily challenges faced by low-income consumers.

Consumers and store owners have urged the Senate to scrap the proposed excise tax on SSBs, which they said will directly hit poor Filipinos.

“If the ‘sweet tax’ is passed, prices of our products will definitely increase, and our customers may not be able to afford them. Our sales and income will drop, and many of us may be forced to close our stores,” Philippine Association of Sari-Sari Stores and Carinderia Owners (Pasco) President Victoria Aguinaldo said.

Aguinaldo, whose group represents 1.3 million sari-sari store and carinderia establishments all over the country, said sweet drinks such as soda, iced tea and ready-to-drink juice, account for 30 percent to 40 percent of their total sales. “These are the same products that ordinary consumers can afford to buy, usually in small sachets,” she said.

Pasco has already gathered 300,000 signatures from across the country to oppose the SSB tax.

The Bantay Konsumer, Kalsada, Kuryente (BK3) supports the campaign of Pasco in opposing the SSB tax, which they said may exacerbate the malnutrition problem in the

BK3 Convenor Louie Montemar said his group will support any action of Pasco because what is at stake in the issue is the interest of the average consumers.  “The bigger problem in the Philippines other than obesity is malnutrition, because many Filipinos do not receive proper nutrition,” said Montemar, a university professor.

Data from the 2017 State of Food Security and Nutrition in the World by the Food and Agriculture Organization show that the prevalence of undernutrition among Filipino children is 13.8 percent, exceeding the prevalence of overweight children at 5 percent and the prevalence of obesity among adults at 5.2 percent.

“If the government will tax all these sweet beverages, which are among the sources of energy of Filipino consumers, then their prices will increase, and it will hurt the consumers,” he said.

Montemar added that, to generate more revenues to support the “Build, Build, Build” infrastructure program, the government should turn its attention to products patronized by the rich and stop the revenue leakage in the Bureau of Customs.

“Definitely, the SSB tax is not the answer because it will directly hit the workers who do not earn enough for daily sustenance,” he said.

Montemar added the government should shift to the public-private-partnership model instead of directly financing large-ticket infrastructure projects with its own budget and foreign loans.

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