Dear FDA: Who paid for the removal of abortion pill safety protocols?

"Dear FDA: Who paid for the removal of abortion pill safety protocols 10 years ago?"

In part one of this series, Live Action News asks the FDA to reveal who wielded financial influence, and how much, in order to get the abortion pill's manufacturer, Danco Laboratories, to pay for a supplemental new drug approval to loosen the drug's safety protocols in 2016, when it had neither any apparent desire to do so nor any funding to make it happen.

Key Takeaways:

• Abortion pill manufacturer Danco Laboratories had no interest in loosening the abortion pill's safety protocols in 2015, and was short by millions of dollars to even attempt it. Some claim Danco 'dragged its feet' because it knew that loosening safety protocols would open the door to generic competitors — which is exactly what happened.

• By 2016, Danco had the millions it needed, obtained from unknown sources, and filed a new drug application in an attempt to have the drug's safety protocols loosened.

• An abortion pill access coalition was strongly pushing to remove all REMS safety protocols at least a decade ago; though they didn't succeed then, many of the immediate changes they sought then have been brought about incrementally over the past decade.

• The FDA needs to answer this question: Who paid for the removal of abortion pill safety protocols, and how much did they fund Danco to ensure that it happened?

The Details:

The Protocols

Prior to 2016, the abortion pill came with a number of safety measures which were wiped out by the Obama administration. As Live Action News previously reported, the administration weakened the drug's safety protocols (abbreviated as 'REMS') by:

• removing the requirements that women/teen girls take the first drug of the abortion pill regimen (mifepristone) in front of a clinician in-person, at the location of a certified prescriber

• removing the requirement for the manufacturer to report the drug’s non-fatal adverse events (complications) to the FDA

• expanding the use of the abortion pill on preborn children from seven weeks gestation (49 days of pregnancy) to 10 weeks (70 days)

The Timeline

1990s: Danco is originally set up by the John D. Rockefeller-founded Population Council, which brings the abortion pill into the United States from overseas.

2000: The FDA approves the abortion pill, which was fast-tracked under the Bill Clinton administration and soon placed under a safety system called REMS (Risk Evaluation and Mitigation Strategies) to monitor the drug.

⭐️ 2015: Abortion pill manufacturer Danco Laboratories seemingly has no issues with the Food and Drug Administration's (FDA) abortion pill safety protocols (REMS) and allegedly does not have enough funds "to file a supplemental [new drug approval] NDA to make the change," according to author Carrie Baker in her book, "Abortion Pills US History and Politics."

⭐️ 2016: Danco somehow obtains the funding to file a New Drug Approval (NDA) supplement and the FDA approves it, loosening the safety protocols for the abortion pill Mifeprex (mifepristone).

2023: The Biden FDA further decimates the REMS to allow for no-test mail-order and pharmacy dispensing, leading to an increase in nationwide abortions. Abortion drugs are shipped into states that have legislatively banned them. (This has prompted multiple lawsuits against the FDA's 2023 REMS changes; six states are involved so far.)

💵 Where did the funds come from for Danco's supplement filing, which it lacked in 2015?

Author Carrie Baker credits Danco's abrupt shift to a pro-abortion coalition — including groups like Planned Parenthood, NARAL, and others — who helped the manufacturer "raise money."

Behind the Curtain:

While Baker did not specify the origin of the funds to file the new NDA, there are several of the "usual" suspects who seem most likely to have been behind it.

Live Action News has documented how pro-abortion philanthropists like the Susan Thompson Buffett Foundation (Warren Buffett) and the David and Lucile Packard Foundation (the latter of which invested millions into Danco early on) have funneled enormous amounts of money into expanding abortion globally.

In a 2021 report, the Packard Foundation acknowledged providing "bridge loans for grantees and other nonprofit organizations," including "reproductive health clinics."

Pro-abortion philanthropists have funded research, studies, and clinical trial sponsors/sites which (unsurprisingly) all claim the abortion pill is "safe." The potential conflicts of interests should be obvious, yet the FDA still has not released the full record of experts who approved the drug or its later changes.

Coalition to Improve Access to Mifepristone

Author Carrie Baker notes in her book that, though "the FDA established a REMS program for mifepristone, incorporating the restrictions placed on the [abortion pill] in 2000" in June 2011, the Coalition to Improve Access to Mifepristone was also seeking to loosen the REMS safety restrictions on the drug.

The Coalition...

• initially consisted of 143 members representing 58 organizations (including Planned Parenthood, NAF, NARAL, and others).

• was founded in 2015 by Gynuity Health Projects (a.k.a. GHP Solutions LLC) and had increased to 264 individuals and 115 organizations by May 2017, and "360 individuals representing 150 organizations" by 2018.

• had a goal which included "ensur[ing] that mifepristone is available in pharmacies and accessible to all U.S. women who need it," according to Gynuity.

• claimed to be advocating for "evidence-based changes to the mifepristone product label, most of which were included in the revised FDA approved label issued in March 2016."

• collaborated to attack Abortion Pill Reversal (APR), even organizing a "Reverse the Rhetoric" meeting, among other strategies, in 2017.

Gynuity, an ongoing sponsor of abortion pill clinical trials and studies (including the mail-order trial) to expand use of the drug, was founded by Beverly Winikoff (a previous employee of the Population Council as the Program Director for Reproductive Health). Winikoff was also in charge of the drug's original clinical trials.

Who funded Danco's new drug application?

The Coalition "urged the drug manufacturer Danco to petition the FDA to modify the Mifeprex label," Baker wrote. To do so would require a New Drug Application (NDA).

In Chapter 2 of her book, Baker writes:

Danco said they didn’t have the funds to file a supplemental NDA to make the change, which could cost millions. In response, reproductive health advocates agreed to help Danco raise foundation money to support making the application.

Baker does not expand upon who funded Danco's NDA, but was clear that:

In May of 2015, Danco submitted a supplemental NDA to the FDA to obtain approval to alter the Mifeprex indication, dosing regimen, and labeling... But they did not challenge several restrictions that were part of the REMS, including the provider certification requirement and the in-person distribution requirement for mifepristone.

The BILLIONAIRES behind ABORTION

Danco had concerns that expanding the REMS might open the door for the approval of a generic abortion pill, hurting its own profits — and it did.

In 2019, the FDA approved GenBioPro (GBP) as a generic abortion pill manufacturer; the very same Packard Foundation, which had seeded Danco, also invested millions into GenBioPro.

Removing the REMS:

Danco 'drags its feet'

Baker noted that in 2015, just a year before the FDA loosened the abortion pill safety protocols, Coalition members (as well as Danco) failed to voice any issues with the protocols in place at that time.

According to Baker, Gynuity's founder Beverly Winikoff said Danco did not want to ask the FDA to remove the REMS. Winikoff felt that "the REMS may have had some commercial advantage for Danco. And without Danco being on board, we couldn’t do it."

Baker also implied that Coalition members sought an "incremental" approach, because, as Winikoff put it, "IRBs [Institutional Review Boards that approve research projects] wouldn’t even touch it if you got too far out ahead of practice. You have to do it incrementally...."

However, Francine Coeytaux, a co-founder of the group Plan C (and sister of abortionist Remy Coeytaux, who is in legal trouble for mailing abortion pills to women in states where it is illegal), "tried to persuade the Coalition to require Danco to push for the full elimination of the REMS rather than just a modification of the label, but the Coalition members supported Danco’s plan to request more limited changes," Baker wrote in her book (emphasis added).

"Kirsten Moore of the EMAA (Expanding Medication Abortion Access) Project also believed Danco did not want the REMS removed," Baker wrote, adding:

She argued that the burdensome REMS restrictions discouraged other companies from developing a generic medication that would compete with Danco’s brand name medication. Not until 2019 did the FDA approve a generic mifepristone, marketed by the company GenBioPro, founded by abortion pill advocates.

Dr. Carolyn Westhoff agreed: “Danco silently dragged their feet on the REMS issue because it would have paved the way for GenBioPro to bring their generic to the market.”

According to Coeytaux:

The Coalition members didn’t have problems with the REMS. They didn’t have a problem with the restrictions. They were the people who already had a great agreement with Danco. They loved the special relationship they had with the FDA. The need to change the REMS was not recognized. They were happy with leaving the REMS in place and just asking for modifications.

Mitchell Creinin, who is on the payroll of Danco, disagreed. "Danco fought hard to remove the REMS multiple times," he claimed, "but the FDA made it really clear throughout the whole process the REMS was not going away."

Creinin presumed the FDA would be concerned about "constant inquiry from all the Republicans in Congress" if those safety protocols were removed.

"You know the amount of work and effort it’s going to take for them to constantly deal with this battle?" Baker quotes Creinin as saying.

Coalition pushes for removal of safety protocols

Baker wrote:

Nevertheless, individual members of the Coalition pushed for full removal of the REMS. In November 2015, twelve leading researchers and four organizations— including the National Public Health Association, NAF, Ibis, and Gynuity—submitted a letter to the FDA asking the agency to change the label in three respects:

1) the location where the patient should take mifepristone should not be restricted;

2) an in-person visit should not be mandated for follow-up assessment; and

3) any licensed healthcare provider—not just physicians—should be able to prescribe the drug.

They also asked for the elimination or substantial modification of the REMS, including the in-person distribution requirement, the provider certification requirement, and the patient agreement form.

This, of course, sounds a lot like what's happening today with regard to the abortion pill.

Interestingly enough, as recently as 2020 — Ibis was directly funded by Danco Laboratories and is currently funded by the Packard Foundation.

Baker continued:

Finally, they asked for an extension of the gestational age limit for medical abortion to seventy days. ACOG submitted a separate letter making the same request.

Then in February 2015, thirty policy, advocacy, social science, research, and academic organizations submitted a letter to the FDA asking them to lift the REMS.

Winikoff, Westhoff, and other researchers also decided to publish a special issue of the journal Contraception with the latest research to support removal of the REMS, which they did in the fall of 2015.

In March 2016, during the last year of the Obama administration, the FDA issued a new REMS for mifepristone and updated the mifepristone label.

The FDA has promised a review of the abortion pill, as safety concerns have been raised by multiple pro-life organizations.