One of the more interesting consequences of this past presidential election is Donald Trump’s nomination of Robert F. Kennedy, Jr., popularly known as RFK, as head of the Department of Health & Human Services (HHS).
As part of his campaign to “Make America Healthy Again,” RFK has pledged to root out corruption at the Food & Drug Administration (FDA). He is on record as a staunch critic of pharmaceutical companies and food producers who he believes have held too much sway over FDA’s decisions regarding the safety and efficacy of drugs and food additives.
If RFK is looking, as we trust he will be, what follows is a prime example of the political corruption of the FDA’s drug approval process.
Though there is no indication that the abortion pill, mifepristone, is currently on his radar, that drug is a prime candidate for review. What is more corrupt than its horrible safety record, further compounded by recent decisions by the FDA to water down regulations on distribution of the drugs at the insistence of the abortion industry and on the basis of studies supplied by that same industry?
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Challenges to the integrity of the FDA’s regulatory review process were summarily dismissed under previous Democrat administrations and were thus exceedingly difficult to challenge in the courts.
But under a new regime, under a new head pledged to return the agency to rigorous scientific scrutiny and a fundamental, primary commitment to public health, perhaps an honest, objective reconsideration of mifepristone’s safety, efficacy, and the conditions of its availability are finally in order.
Problems with the original approval
Courts have already ruled that challenges to the original 2000 approval are too late at this point. So, it may not legally matter that corners were cut and that the usual scientific standards were ignored.
Though it did not really meet the criteria, mifepristone was approved under Subpart H, a clause normally reserved for potentially life-saving drugs. This allowed them to skip some critical important preliminary testing in order to get them to market right away.
Pregnancy was clearly not a life-threatening illness but an FDA drug review panel stacked with abortion advocates and industry activists recommended approval. However, originally, they did urge a number of conditions and safeguards because of concerns about mifepristone’s safety and efficacy.
Several pro-life doctors challenged the legality of that approval in Alliance for Hippocratic Medicine v. FDA in 2023 (later renamed FDA v. AHM). But a federal judge ruled that their challenge came too late to revisit that initial approval.
Protocol changes despite unresolved safety issues
In the years following approval, several women died after taking the abortion pill. They bled to death, contracted deadly infections, or experienced a previously undetected ectopic pregnancy rupture. Hundreds of other women were treated and admitted to hospitals for hemorrhage or other dangerous complications.
The FDA and the U.S. Centers for Disease Control (CDC) investigated the sudden spate of infection deaths, but ultimately (and without solid statistical backing) attributed them to general pregnancy risks.
Meanwhile, the abortion industry pushed for dropping the original safeguards the FDA imposed on prescription of mifepristone back in 2000. In the years that followed, they published research on some of the individual elements they found most limiting.
Relying on many of those studies by industry insiders, the FDA announced changes to the protocol in 2016, beginning the pattern of eliminating protections for women. They altered dosages; extended the gestational cutoff from seven weeks LMP (pregnancy dated after a woman’s last menstrual period) to ten weeks LMP; reduced the number of required visits from three to one; allowed any certified healthcare provider (not just doctors) to prescribe; and only requiring deaths (rather than all serious complications) to be reported to the manufacturer and FDA.
The agency argued that each of these changes had individually been shown to be safe in studies. However, the FDA neglected to explain how it was able to determine that all these changes taken in combination (dose changes, extended cutoff, reduced visits, prescription by lower level clinicians, etc.) would not prove disastrous. With data on complications no longer required to be reported, it would become exceedingly difficult for the agency to determine the actual consequences of their decision.
Further compromising the agency’s review was the
FDA’s reliance on studies conducted by abortion advocates, many with political if not financial interests in the agency’s decision.
Using a medical crisis to bend or break the rules
One of the things that RFK is best known for is his objection to the use of the pandemic to prompt a national vaccine mandate. Mifepristone is just one more example of how Biden was able to use the COVID crisis to push the FDA to abandon most of the remaining safeguards in order to allow abortion pills to be mailed to women’s homes without any in-person screening, counseling, or monitoring.
A lawsuit by abortionists was able to temporarily get in-person distribution suspended during the last year of the Trump administration. But it was the hardcore pro-abortion Biden administration that made this suspension permanent and got the FDA to set up a system whereby abortion pills could be sold and shipped by online merchants or picked up from local pharmacies.
Again, this change was made with little-to-no consideration of data from outside the abortion industry studies designed and spun to support these radical changes.
Objective studies say otherwise
Studies from other countries with similar distribution systems to the ones the FDA authorized showed significant numbers of complications and incomplete abortions. In many cases the numbers were much higher than those reported by the American abortion industry’s studies relied upon by the FDA.
For example, researchers from Canada looked at nearly 40,000 abortion patients in Ontario between 2017 and 2020. They found nearly 10.3% of the chemical abortion patients visited the emergency room with some concern or complaint (Annals of Internal Medicine, 1/3/23). Notably, Canada has a pharmacy distribution system similar to the one proposed for the United States.
An analysis by a former executive at Britain abortion giant’s Marie Stopes International found that 5.9% of chemical abortion patients were treated for complications connected to incomplete abortions or “retained products of conception.” Three percent of women there required surgery to deal with incomplete abortions and 2.3% of these patients were treated in National Trust hospitals for hemorrhage. Rates were higher after the institution of the mifepristone mailing program than before (Percuity, 10/27/21). Ambulance calls in Britain also jumped after the “Pills by Post” system went into operation, increasing by more than 50% in some areas, up at least 25% in others (Daily Express (London), April 25, 202).
More recently and closer to home, a study by a researcher from the Heritage Foundation found a jump in emergency room visits in New Jersey, South Carolina, and Arkansas (the only states from which data for this time frame was available) for abortion complications after the FDA authorized changes in the mifepristone protocol. Remarkably, emergency treatment for “miscarriages” also went up. This is relevant because many abortion pill prescribers have explicitly recommended that aborting women not reveal their use of mifepristone to ER doctors, but simply claim to be miscarrying (Jonathan Abbamonte, Heritage Foundation 11/4/24).
The FDA’s reliance on abortion industry studies allows abortion advocates to spin the data, to classify incomplete abortions, hemorrhages, and other complications requiring surgery as “minor,” to get away with ignoring the fate of hundreds of women “lost to follow-up” by researchers.
If RFK is looking for situations where industry and political aims have been given undue deference in the FDA review process over competing views, look no further than mifepristone.
The FDA should protect patients, not the abortion industry
Truth be told, mifepristone should never have been considered by the FDA in the first place. It was not a drug which was offered to cure any disease or treat any illness. Its intent was to kill unborn babies, to starve or suffocate them and then, with the aid of a powerful prostaglandin, to violently force them out of the womb.
It is painful, bloody, and dangerous. It puts healthy women in the hospital and sometimes– especially under the new looser regulations recently authorized by the FDA – in the grave. (See “Dead Georgia Woman a Victim of Biden-Harris Abortion Pill Deregulation, Not State Law,” NRL News Today, 9/25/24)
If RFK wants to clear the slate at the FDA and put the agency back on the side of American patients, this would be a great place to start.
LifeNews.com Note: Randall O’Bannon, Ph.D., is the director of education and research for theNational Right to Life Committee. This column originally appeared at NRL News Today.
