“In my understanding, since the FDA had already issued an advisory, the TRO is lifted. There’s nothing wrong if FDA furnishes the (SC) with a copy but the lifting is automatic,” he noted in an ambush interview. Photo by bepster on Flickr/CC BY-NC-SA, File

TRO on contraceptives now lifted – DOH
Sheila Crisostomo (The Philippine Star) - November 14, 2017 - 4:00pm

MANILA, Philippines — The temporary restraining order (TRO) issued by the Supreme Court (SC) on contraceptives more than two years ago is now lifted, the Department of Health (DOH) said yesterday.

The TRO was automatically lifted when the Food and Drug Administration (FDA) issued an advisory declaring all of the 51 contraceptive products as “non-abortifacient,” according to Health Undersecretary for Health Regulation Mario Villaverde.

“In my understanding, since the FDA had already issued an advisory, the TRO is lifted. There’s nothing wrong if FDA furnishes the (SC) with a copy but the lifting is automatic,” he noted in an ambush interview.

Villaverde had earlier reiterated the assurance that the DOH is well prepared for the full implementation of the Responsible Parenthood and Reproductive Health (RPRH) law now that the TRO is gone.

In issuing the TRO in June 2015, the SC directed the FDA to stop renewing the certificate of product registration (CPR) of all contraceptive products.

On the other hand, the DOH was prohibited from including subdermal implants, which can stop pregnancy for three years, in its family planning program.

Release of implants

For former health secretary and current RPRH law national implementation team head Esperanza Cabral, priority now should be the distribution of the subdermal implants being kept at the warehouse of the DOH.

“The first thing that the team will do is to recommend to the DOH the release of the implants that have been held by the TRO for the last two years so they can be used by women who need them,” she added.

She estimated that some 250,000 implants are now in the DOH storage. These contraceptives are the subjects of a petition filed by pro-life group Alliance for Family Foundation Philippines Inc., prompting the high tribunal to issue the TRO.

Cabral said in a separate interview that the DOH will also have to procure contraceptives “that they have not been able to procure because of the TRO.”

She added that the DOH’s supply of Progestin-only pill is now “zero” while the supply of injectale contraceptives is running out.

No need for SC order

There is no need for an order from the SC allowing the distribution of the 51 contraceptive implants cleared by the FDA as it was already implied in its final decision on the case issued earlier this year.

SC spokesman Theodore Te has repeatedly explained that the TRO issued by the high court on the distribution by the DOH of two contracpetives, Implanon and Implanon NXT, is automatically lifted upon issuance of new certification by the FDA.

Implanon and Implanon NXT are thin rods inserted under the skin, which release hormones that prevent pregnancy for up to three years.

He cited the final and executory ruling of the Second Division of the high court that voided the certifications issued by the agency on Implanon and Implanon NXT and included a TRO on the distribution of such contraceptives.

The SC denied the appeal of the DOH seeking to proceed with the distribution of the contraceptives and gave the FDA 60 days to decide on whether these implants are abortifacient or can cause abortion and re-issue the certification in its final ruling last April. It issued the entry of judgment last September.

Te also reiterated that the SC ruling “involves a TRO over two implants only and not all contraceptives and not over the entire RH Law.”

In its 2015 ruling, the SC struck down the certifications and re-certifications issued by the FDA on 77 contraceptive drugs and devices, including Implanon and Implanon NXT, for violation of constitutional requirement of due process.

Tough time at Senate??

Meanwhile, the DOH and the FDA could be in for a tough time at the Senate when their 2018 budgets are taken up in the plenary in the next two days as a result of the clearance given to 51 contraceptives tagged as abortifacients by critics of the RPRH law.

Senate Majority Leader Vicente Sotto III noted that the Alliance for the Family Foundation Philippines Inc., which filed the petition before the SC, is well aware of which contraceptive products could induce abortions and which do not.

“Ako, pagod na (I’m tired of this already),” Sotto said.

With the go signal given by the FDA on the 51 contraceptives, including Implanon and Implanon NXT, Sotto said it is now the agency’s responsibility to address whatever negative impacts their decision would have on the public.

Sotto said he expects the issue to be taken up during the plenary debates on the 2018 budget where the representatives of the DOH and FDA would be present to defend their respective budgets.

“Aabangan ko na lang budget nila (I will just wait for their budgets). Watch out!” he said.

Sotto said he would be watching out for the cost of the contraceptives in the market, which he said could be overpriced.

What is more of a concern to him, though, is the procurement of the contraceptives by the government for implementation of the RPRH Law, which he has been questioning since the bill was being tackled in the Senate.

“It’s alright if it’s being sold in the market because private individuals can do whatever they want to do with their own lives,” Sotto said.

“The point is when you use government funds to buy it. Would (taxpayers) agree to using (their) money to purchase products that could be abortifacients?” he added.

Sotto said that the public should realize this before supporting groups behind the supply of these contraceptives. – With Edu Punay, Marvin Sy

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