Analysis

If the FDA removes abortion pill safety protocols, it won’t be because the drug is safe

abortion pill abortion pill reversal

The original approval process for the abortion pill in the United States two decades ago was highly politicized, with the Food and Drug Administration (FDA) refusing to even publish the names of the “experts” who initially reviewed the drug. Today, as abortion advocates fear Roe v. Wade is in peril, that politicization continues in the form of lawsuits and regulatory decisions to expand the abortion pill.

Lifting FDA’s REMS safety program

The abortion pill is currently under an FDA safety program called the Risk Evaluation and Mitigation System (REMS), which the  FDA can require “for certain medications with serious safety concerns.”

Under REMS, mifepristone (brand name Mifeprex) — one of the two drugs in the abortion pill protocol — “must be dispensed to patients only in certain healthcare settings, specifically clinics, medical offices, and hospitals, by or under the supervision of a certified prescriber.” Teen girls and women may only obtain the abortion pill with an in-person visit to a certified prescriber of the drug, who for safety purposes must be capable of properly assessing gestational age and deadly ectopic pregnancies. In addition, the REMS safety regulations require providers to sign the manufacturer’s prescriber agreement and they must stock the drug, since it currently cannot be dispensed in a pharmacy.

However, using the ruse of the COVID-19 pandemic, the Biden-Harris administration’s FDA has allowed the pills to be dispensed online, by approved prescribers, for the duration of the pandemic.

Chelius v. Becerra (originally Chelius v Wright)

At the time the abortion pill was first approved (2000), the industry believed that doctors would be willing to prescribe the regimen — but they were wrong. In 2001, The Washington Post wrote:

At one time, the most ambitious argument for RU-486 was that it would move abortion away from clinics (and clinic protesters) and into the offices of more private OB-GYNs and family practitioners. But there have been signs all along that this is not likely: In a survey conducted by the Kaiser Family Foundation, doctors tended to be less willing to administer RU-486 the more they knew about it.

Even as late as 2016, abortion pill manufacturer Danco’s director of marketing and public affairs, Abigail Long, told Forbes that Danco’s representatives regularly encounter physicians who say they simply send their patients to Planned Parenthood.

Fast forward to 2019, and little had changed when abortionist Daniel Grossman told Ms. Magazine that one reason OB-GYNs did not offer the abortion pill is because they do not want to stock it in their facilities.

So, in 2017, the American Civil Liberties Union (ACLU) filed the Chelius case to challenge the REMS on behalf of Hawaiian doctor Graham T. Chelius, who argues that complying with the REMS requirements to “procure, stock, and dispense Mifeprex” at his medical facility “rather than issuing a prescription, from the privacy of my office” would, in his words, “disrupt” and “interfere” with his ability to “serve” his patients.

“For many health care providers across the country, registering with the drug manufacturer and stocking Mifeprex at their office is difficult or impossible,” the lawsuit alleges. “Some are deterred by the logistics of being ‘certified’ by a drug manufacturer, entering into a contract with the drug distribution company, and ordering the medication—a process unfamiliar to many clinicians because it is required for such a small number of drugs, and which can be particularly complicated and time-consuming for clinicians at large health care institutions.”

American College of Obstetricians and Gynecologists (ACOG) v. FDA

As previously mentioned, the abortion industry used the COVID-19 pandemic to lift the REMS and expand access to the abortion pill. Yet, well before the pandemic, the industry had expanded its abortion pill clinical trials and then rolled out a “no test” abortion pill protocol, which some medical professionals have said endangers women. Around the same time frame, the ACOG also changed its recommendations to line up exactly with the abortion industry’s attempts to expand access to the abortion pill.

The ACOG is not an impartial medical organization; it is radically pro-abortion.

ACOG’s move towards abortion was influenced by population control enthusiasts who eventually redefined the beginning of life. The organization has been funded by groups that directly received funds from U.S. abortion pill manufacturer Danco Laboratories.

In May 2020, the ACLU filed a lawsuit on behalf of the ACOG to suspend the FDA’s REMS during the COVID-19 pandemic. The lawsuit asserted that allowing the drug to be sold only in an approved clinic or hospital put abortion seekers at risk for the coronavirus. At the time, the FDA under the Trump administration chose to stand by its safety requirements, calling the lawsuit’s assertions about risking patients’ lives “speculative” at best.

But in July 2020, U.S. District Judge Theodore D. Chuang placed the in-person safety requirement under a preliminary injunction during the COVID-19 pandemic. By October that same year, based on the order enabling pharmacies to stock and subsequently mail abortion pills for a certified prescriber, U.S. based online pharmacy Honeybee Health agreed to distribute the drug directly to women by mail for abortion providers who prescribe it.

A few months later (December 2020), Judge Chuang denied the Trump administration’s request to reinstate the REMS requirements.

Enter the Biden Administration…

FDA to review REMS

President Joe Biden promised to promulgate the extreme expansion of abortion under the Biden-Harris Administration. He took office in January of 2021 and placed the FDA under the direction of newly-appointed, radically pro-abortion HHS Secretary Xavier Becerra.

By February of 2021, Planned Parenthood and its Congressional allies sent a letter to acting commissioner Dr. Janet Woodcock pressuring the FDA to lift the REMS. And the FDA swiftly complied, at least temporarily. On April 13, 2021, Woodcock issued a letter to ACOG telling them the agency would continue to allow the distribution of dangerous abortion drugs by mail for the duration of the pandemic.

Woodcock previously served as Director of the FDA’s Center for Drug Evaluation and Research when the Agency approved the abortion pill.

In May of 2021, a motion to stay the Chelius case was enacted until December of 2021 when the FDA review of the REMS was expected to be final. Then on November 3, 2021, a status update was filed, which indicated that the “FDA… anticipates completing its review by December 16, 2021” and the stay on the lawsuit was extended until January 14, 2022 to “give the Parties time to determine appropriate next steps in this litigation.”

“If FDA’s review of the REMS, and implementation of any changes to the REMS that result from such review, are not completed before the expiration of the COVID-19 Public Health Emergency (“PHE”), FDA agrees that it intends to exercise its enforcement discretion with respect to the in-person dispensing requirement of the mifepristone REMS… for a further 30 days following the end of the PHE,” the court document also states.

The FDA has not indicated exactly who will review the REMS or whether it will rely on studies authored by so-called ‘experts‘ often in the pocket of the pill’s manufacturer Danco Laboratories or its generic GenBioPro. And, while we await their review, abortion proponents continue to actively flout the REMS and flood abortion pills into every sector of society — no matter the safety cost.

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