[OPINION | DASH of SAS] Lifting TRO on contraceptives: Waiting for the FDA
The Supreme Court’s Temporary Restraining Order on contraceptives is almost lifted. Almost.
Thursday, November 2, was supposed to bring a decision that would end the temporary restraining order (TRO) that led to the gradual phasing out of hormonal contraceptives.
The Food and Drug Administration (FDA) is about to finish its evaluation of 51 contraceptives and was expected to issue a resolution by October 30, 2017.
This was one of the requirements stipulated by the Supreme Court to lift the 40-month TRO on contraceptives the High Court had imposed starting June 2015. (Another requirement of the Court, revising certain provisions of the Implementing Rules and Regulations of the RH Law will be the subject of another column.)
But the FDA did not issue the resolution yet. Instead, the members of the Reproductive Law national implementation team who gathered for a press conference earlier today were informed that the FDA was ready to recertify 35 contraceptive brands and was still discussing the remaining 16 brands.
"We eagerly look forward to the certification of these 51 contraceptives as non-abortifacient so that they can be used by the 13 million women who either are using modern methods of family planning or need to use modern methods of family planning," said Esperanza Cabral chairperson of the RH Law National Implementation Team.
Cabral was speaking for the estimated 7 million Filipino women who are on birth control and another 6 million women who need birth control but do not have access to it, and who are just as eager to get the FDA resolution.
So, no champagne, no cigars, no confetti just yet.
Before we go any further, let’s take a quick look back at how we found ourselves in this hot mess of contraceptives disappearing from drug store shelves and public health clinics.
Flashback: The unkindest cut of all
A petition raised by pro-life group Alliance for the Family Foundation (ALFI) asked if sub-dermal implants (a hormonal contraceptive shaped like matchsticks that are inserted in the upper arm and provides contraceptive protection for 3 years) induced abortions. (They don’t.)
The Court issued a TRO on implants until the matter was resolved. When the DOH petitioned to lift the TRO, the Court responded with a decision that effectively expanded the coverage of the TRO:
….effective immediately and continuing until further orders from this Court aTEMPORARY RESTRAINING ORDER enjoining the respondents, their representatives, agents or other persons acting on their behalf from:  granting any and all pending applications for registration and/or recertification for reproductive products and supplies including contraceptive drugs and devices...
Cabral explained this provision, “The consequence is, previously marketed contraceptives could not be marketed anymore after their certificates of registration expire until they go through the process of ‘proving’ that they are not abortifacient.”
In the long list of monkey wrenches thrown at the RH Law, this was the unkindest cut of all.
Well, because it is the Supreme Court. The finality of a Supreme Court decision is the closest you will get to forever in this life.
Without being able to procure new contraceptive brands or re-stock existing ones, contraceptives began disappearing, endangering millions of women who need birth control for fertility management, to regulate their periods or manage conditions like polycystic ovarian syndrome (PCOS).
In September, the Supreme Court came out with a judgment with a self-lifting provision of the TRO as soon as the following conditions are met: (1) certification and evaluation by the FDA that contraceptive brands are non-abortifacient and (2) revision of certain provisions on the Implementing Rules and Regulations (IRR) of the RH Law.
When these conditions are met:
- The Department of Health (DOH) would again be allowed to procure hormonal contraceptives and restock their public health clinics and hospitals.
- The DOH would also be allowed to administer the estimated 200,000 sub-dermal implants that have been languishing in their warehouses since the TRO was issued.
- The implants are scheduled to expire in September 2018. Their shelf life is 11 months and counting.
- Pharmaceuticals will again be allowed to import new stocks of contraceptive brands and apply for the certification of new brands.
In short, contraceptive supply should start going back to normal. Over time.
For the public health sector, it will take between a year to a year-and-a-half for stocks to normalize. That’s how long it takes for the health department to bid, procure, pay for, and distribute contraceptives and finally make them available to the millions of women who line up at public health centers to get them.
Worst case scenario
If the FDA resolution certifies some brands but does not certify others, it may set a dangerous precedent.
“Internationally, we would be the first country to go against the global assertion that contraceptives are part of the essential medicines list,” said Dr Junice Melgar, executive director of Likhaan Women’s Health Center.
Lawyer Katherine Austria-Lock of the FDA confirmed that the FDA will issue anytime soon the resolution on 35 contraceptive brands but are still evaluating the 16 other brands.
“We will issue the resolution anytime soon but cannot give a date at this time. We are being very careful in the evaluation process because we want to avoid the issuance of another TRO in the future,” said Austria-Lock.
Additionally, DOH secretary Francisco Duque had just been appointed and had to be brought up to speed on the issue.
Duque served as the DOH secretary during the Arroyo Administration which allocated public funds only for natural family planning methods.
“We were getting ready for a victory march,” said Melgar about the much anticipated release of the FDA resolution. “But it may just turn out to be an indignation march.”
Let’s hope not.
We shouldn’t take any chances. We need to make sure the FDA hears our voices. We need to let them that we urgently need them to complete the resolution on the 51 contraceptive brands – the final step in lifting the TRO on contraceptives. This is the last and much needed step to lift the TRO and finally (hopefully) give millions of Filipino men and women rightful access to birth control.
As every woman knows, the words “female empowerment” are nothing more than a cliched advertising tagline unless her autonomy to decide over her own body is respected and protected. – Rappler.com
Ana P. Santos is Rappler’s sex and gender columnist and an independent journalist. In 2014, she was awarded the Miel Fellowship by the Pulitzer Center on Crisis Reporting in Washington, D.C.