With FDA nod, SC seen to OK 35 contraceptives

At least 35 of the 51 contraceptive products being tested to determine if they are safe to use and cannot cause abortion may already have been cleared by the Food and Drug Administration (FDA).

A women’s health organization advocating the Reproductive Health (RH) law, Likhaan, says this is good news for the long-awaited lifting of a temporary restraining order (TRO) issued by the Supreme court on contraceptives.

Likhaan director Dr. Junice Melgar said in a press conference on Thursday they believed the 35 were “nonabortifacients,” meaning the products cannot cause abortion.

Nonabortifacient

“There are already 35 out of the 51 products that have been publicized as being nonabortifacient. We have learned that only 16 remain up for consideration by the FDA (Food and Drugs Administration) with regards to the recertification process,” said Melgar.

The list of safe contraceptive products will only be made official by the FDA.

Commission on Population (PopCom) executive director Juan Antonio Perez said he expected the FDA to issue a resolution soon certifying all or most of the 51 contraceptives as nonabortifacients.

The Supreme Court had earlier said that the two-year-old TRO would be lifted only after the FDA had completed its recertification process and promulgated a decision.

RH Law

“FDA will declare contraceptives as nonabortifacients, lifting the TRO. Full implementation of the RH Law (will now be) on track,” Perez said.

Melgar believes that the 16 products which have yet to be declared as nonabortifacient could be those with the levonorgestrel, a hormonal medication.

Out of the 51 products undergoing FDA recertification, 14 contain the substance, which is linked to the controversial “morning-after pill,” according to her.

Melgar noted that levonorgestrel was previously banned in the country supposedly for causing abortion.

According to Perez, the FDA was finishing the recertification process of the 51 contraceptive products, including the controversial implants, Implanon and Implanon NXT.

TRO lifted

“I have been assured [by the FDA] that whatever decision they make, the resolution will lift the TRO,” he said. “We will only find out, when they come out with their decision, what the actual number [of approved products] will be.”

The Supreme Court and Congress had added another level to the FDA recertification process to make sure the products were not abortifacient.

“It’s very clear that all the 51 have already passed the measure of safety efficacy, they are not dangerous at all,” Perez said.

Pro contraceptives

Advocates of the RH law, including Forum for Family Planning, have urged the FDA to speed up the vetting of contraceptives products.

“It has been two long years and here we are still fighting for the full implementation of our family planning program… The bottomline is that the FDA has to make a very fast decision on this matter,” said De Leon.

“We are looking forward to the day when every Filipino of reproductive age is provided with the whole range of quality family planning products and services that are effective, medically safe and nonabortifacient,” she added.