‘35 of 51 contraceptives safe, non-abortifacient’

By Sheila Crisostomo (The Philippine Star), Nov 3, 2017

MANILA, Philippines — Thirty-five out of 51 contraceptives have so far been recertified as safe, effective and non-abortifacient by the Food and Drug Administration (FDA).

This was revealed yesterday by Likhaan Center for Women’s Health executive director Junice Melgar, saying that this “goes against global assertion that all contraceptives are actually part of essential drugs and that they are non-abortifacient.”

“If they (FDA) say some contraceptives are abortifacient, we will be the first country that actually would say so,” Melgar told a press conference.

For her part, FDA director general Nela Charade Puno maintained that the agency “will soon release its resolution on the listed products.”

Former health secretary Esperanza Cabral, who heads the Department of Health’s national implementation team of the Reproductive Health Law, and Commission on Population (PopCom) executive director Juan Antonio Perez III did not confirm or deny Melgar’s pronouncement.

Both Cabral and Perez were designated DOH spokespersons for reproductive health by Secretary Francisco Duque III, a known supporter of natural family planning methods.

Perez claimed the proceedings of the FDA are ongoing and the agency will soon release its resolution on the products.

“I respect their (FDA) need for independence, their need for time to consider these matters. I’m sure they know the urgency so they must be on the edge of coming out with a resolution,” Perez said.

According to Cabral, the FDA does not have to recertify all of the 51 products for the temporary restraining order (TRO) issued by the Supreme Court (SC) in June 2015 to be lifted.
“I think the FDA should have independence from vested interest, from people who want to make a profit out of things that are regulated by the FDA. But they should listen to the voice of the people, as far as their needs are concerned and they should make sure that they are on the side of human rights,” Cabral said.

Conflicting interpretations

For two months, the FDA had reviewed 51 contraceptives in compliance with an order of the SC for the TRO issued on the products two years ago to be lifted.

But PopCom and Chief Justice Maria Lourdes Sereno have varying interpretations of the products covered by the TRO.

In July, Sereno said the TRO is limited only to Implanon and Implanon NXT, the subdermal implants that prevent pregnancy for three years.

According to Perez, Sereno was referring only to the “second part of the TRO issued on June 17, 2015 which restrained the DOH from using the two products.”

He said the first part of the TRO specifically ordered the FDA to refrain from “granting any and all pending applications for registration and/or recertification for contraceptive drugs and devices.”

Perez added that only condoms are not covered by the TRO.

The SC has said the second order superseded the first one and the TRO covered only Implanon and Implanon NXT. This means that the determination of the safety of the two contraceptives is with the FDA, which is an agency under the DOH.

Levonorgestrel

Melgar added that based on the list of 51 products, those with the controversial Levonorgestrel in their ingredients could not be recertified by the FDA.
She said Levonorgestrel – banned by the DOH in 2001 – is an active ingredient of “morning-after pills” or “emergency pills” used by those who engage in unprotected sex.
The ban, which stemmed from accusations of pro-life groups that morning-after pills cause abortion, was not lifted because the manufacturer had pulled out the product from the market. 
“Levonorgestrel in the current products is very minimal. They are in combined pills,” Melgar added.
The two Implanon products do not contain Levonorgestrel but Etonogestrel.

Maternal deaths

Citing the estimates of the Philippine Statistics Authority, Perez said since the TRO was issued in June 2015, some 1,000 women have died from pregnancy and childbearing complications.

He said the TRO had also caused some 500,000 unintended pregnancies.

For his part, Forum for Family Planning and Development Inc. president Benjamin de Leon has urged the FDA to speed up resolution.
“It has been two long years and here we are still fighting for the full implementation of our family planning program. The FDA has to make a very fast decision on this matter,” De Leon said.
Products with Levonorgestrel are:

• Levonorgestrel 52 mg (20 mcg/24 hours) Intrauterine Delivery System (Mirena)

• Levonorgestrel + Ethinylestradiol 151 mcg/ 30 mcg tablet (Julianne)

• Levonorgestrel + Ethinylestradiol 153 mcg/ 30 mcg tablet (Nordette)

• Levonorgestrel + Ethinylestradiol 152 mcg/ 30 mcg tablet (Lady)

• Levonorgestrel + Ethinylestradiol 125 mcg/ 30 mcg tablet (Denise)

• Levonorgestrel + Ethinylestradiol 100 mcg/ 20 mcg FC tablet (Minipil)

• Levonorgestrel + Ethinylestradiol 150 mcg/ 30 mcg tablet (Seif)

• Levonorgestrel + Ethinylestradiol 50 mcg/ 30 mcg tablet (Logynon 21)

• Levonorgestrel + Ethinylestradiol; Ferrous Fumarate 150 mcg/ 30 mcg/ 60 mg tablet (Protec)

• Levonorgestrel + Ethinylestradiol; Ferrous Fumarate 150 mcg/ 30 mcg/ 75 mg tablet (Famila 28F)

• Levonorgestrel+ Ethinylestradiol + Ferrous fumarate 150 mcg/ 30 mcg /60 mg tablet (Femme)

• Levonorgestrel+ Ethinylestradiol + Ferrous fumarate 125 mcg/ 30 mcg/ 75 mg tablet (Ruby)

• Levonorgestrel+ Ethinylestradiol + Ferrous fumarate 125 mcg/ 30 mcg/ 75 mg tablet (Trust Pill)

• Levonorgestrel+ Ethinylestradiol + Ferrous fumarate 150 mcg/ 30 mcg/ 75 mg tablet (Charlize). – With Edu Punay