Monday, November 13, 2017

FDA Recertified all 51 Contraceptives as Non-Abortifacient

The Food and Drug Administration (FDA) released the results of the re-evaluation of contraceptive products and re-certified all of them to be non-abortifacients.

In an advisory statement dated November 10, 2017, the FDA 51 contraceptive supplies including the contended Etonogestrel otherwise known as Implanon & Implanon NXT. FDA Director-General Nela Charade Puno assured the general public that review on contraceptive supplies was "aboveboard and transparent" and was fully-compliant to the standards set by the Supreme Court. 

The High Court ordered the re-certification of these contraceptives to obtain a conclusive finding of whether or not they can cause or induce abortion. Last June 2017SC issued a resolution clarifying that only Implanon and Implanon NXT subdermal implants are covered by the temporary restraining order it issued 18 months ago. The tribunal rejected a petition to reverse the stay order but instead gave the FDA 60 days to issue the certification

According to Puno, the pieces of evidence submitted by various groups such as the Alliance for the Family Foundation, Philippines, Inc. (ALFI) either to support or oppose the approval of the contraceptives “have been strongly considered and exhaustively evaluated in this process”. 

“We are grateful for the interest and the productive participation of these civic groups in the process of regulation of these health products,” Puno said. She added that the input given by these groups “have ensured that the results of the certification and re-certification processes will have solid technical and scientific bases”. 

The FDA urged groups interested in submitting input for the certification and recertification process to provide the agency with evidence last August 21 this year. The interested parties were given 10 days to submit their input and were informed of the process that the FDA will follow in the evaluation and review of the contraceptives concerned. 

Puno also clarified that the FDA is strictly following the standards set by the Supreme Court as contained in the latter’s decision in a related court case. “We will make sure that the results of the technical and scientific processes to evaluate and reevaluate these contraceptives will be made accessible to the public,” Puno said. 

Puno said the “scientists who comprise the technical evaluation team of the FDA adhere to the highest professional standards and are committed to a transparent evaluation process”. “These standards of excellence and transparency ensure that the interest of the public is protected,” Puno added. 

With the recertification of the contraceptive supplies by the FDA, it is expected that the temporary restraining order will be lifted and such supplies will be readily available for public consumption. 

No comments:

Post a Comment