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December 20, 2022

Students for Life of America Files Second Citizen Petition to the FDA, calling for Higher Medical Standards Protecting Mothers Taking Chemical Abortion Pills to be restored

 

“The Biden Administration’s decision to put mothers at risk of injury, infertility, and death from Chemical Abortion Pills is a negligent act,” said Students for Life of America’s Kristan Hawkins. “On the same day that the FDA pulled a COVID vaccine after one woman died, we learned officials dropped protections assigned to Chemical Abortion Pills despite the fact that at least 26 women that we know of have died when exposed. Making it easier to sell Chemical Abortion Pills supports the corporate interest of Planned Parenthood & Co., cutting costs for them and cutting care to women.” 

THE WHAT’S IN THE WATER PROJECT OVERVIEW: 

  • The second Citizens’ Petition looks at how lowering medical standards during Democratic Presidents’ control of the FDA, women have been put at risk. Such standards had a role in protecting women and in preventing “patient abandonment.” 
  • The first in the series was the Students for Life Citizen Petitions sent to the FDA on Red Bag Medical Waste as a way to protect aquatic life, animals, people, and the environment from tainted blood, tissue, and human remains. “We’re calling on an environmentally concerned Congress and state legislators to support Red Bag Medical Waste disposal of tainted human remains, to protect aquatic life, endangered species, and our food supply from the deadly consequences of Chemical Abortion Pills, a clinical abortion agent and potential endocrine disruptor that even the National Institutes of Health notes can impact more than just women,” said Hawkins. 
  • Students for Life of America to issue a “What’s in the Water? Drinking Challenge” on Campus Tours 
  • Federal and State Legislative Efforts Underway 
  • Targeted (Freedom of Information Act) FOIA requests on whether states are testing for Chemical Abortion drugs in the water, which illustrate the Don’t Ask/Don’t Tell nature of the environmentally negligent distribution 

 

 

WASHINGTON D.C. (12-19-2022) – Students for Life of America (SFLA) President Kristan Hawkins said that a second citizens’ petition has been filed continuing SFLA-SFLAction’s “What’s in the Water?” Project, calling on the FDA to return health and safety standards known as REMS (Risk Evaluation and Mitigation Strategy) designed to save mothers’ lives when exposed to Chemical Abortion Pills. For example: Despite all the recent coverage of the risks of ectopic pregnancies, which can only be detected with an ultrasound, the Biden Administration reduced health and safety standards to no longer require that kind of screening – even though women who’ve had ectopic pregnancies have died after taking the pills, as the FDA reports, because those drugs don’t treat that life-threatening condition.

CLICK HERE FOR SFLA’S SECOND CITIZENS’ PETITION: Reverse the 2021 and 2016 Mifepristone REMS modification & restore the REMS as they were in 2011. 

“Women’s lives don’t seem to matter to the Biden Administration as long as a baby is dying from an abortion,” said Hawkins. “The FDA will block baby food and e-cigarettes on suspicion of harm, but faced with known risks from deadly abortion drugs, they shrug their shoulders.”

The second petition reports: “Mifepristone carries risks of life-threatening hemorrhage, infection, continued pregnancy, retained tissue, need for emergency surgery, and death. The 2011 regimen provided significantly more protections for patients than the 2016 regimen or the 2021 regimen. FDA should restore and strengthen elements of the Mifepristone regimen and provider requirements, including: limiting Mifeprex use to 49 days’ (7 weeks) gestation; requiring that Mifepristone be administered only by or under the supervision of a physically present physician; requiring three office visits by a patient who has been prescribed Mifepristone; and clarifying that Mifepristone use is contraindicated for patients who do not have convenient access to emergency medical care. The agency should restore the original Mifepristone REMS and return to limiting the dispensing of Mifepristone to patients in clinics, medical offices, and hospitals, by or under the supervision of a certified prescriber.”

 

 

Consider also that more than 30 years ago, when the two-drug regimen that is Chemical Abortion Pills were approved, it was done as an “emergency,” with reduced standards for approval. The petition notes: “When the FDA approved chemicals abortions, it did so under an accelerated process for drug approval under 21 C.F.R. § 314(H). Before chemical abortions were approved, this approval process had only been used on 30 drugs, all of which were for HIV/AIDS, cancer, and other debilitating diseases. Because chemical abortions were approved under this method, it did not have to go through testing for long-term effects that other drugs have to. This raises red flags as this drug could potentially cause more serious adverse side effects to women.”

Hawkins noted: “Drugs for ending life were pushed through without thorough examination, and after years of freedom of information requests, we still don’t know just what ‘studies’ the FDA relies on to allow them to stay on the market without better REMS, exactly where they are manufactured, or when those facilities were last inspected. After 30 years however, the emergency is long gone, and a failure to fully protect those exposed to the drug should require its removal from the market or at least a complete change in Biden’s No Test, Online Distribution scheme.”

Students for Life of America & Students for Life Action have long prioritized addressing the dangers of Chemical Abortion Pills, now the number one cause of death by abortion. You can read more about the new campaign addressing environmental harms in The Washington Post, including a second key article, as well as in Politico, and USA Today, among other publications. 

 

 

CLICK HERE TO READ THE FIRST OF SFLA’S INNOVATIVE CITIZENS’ PETITIONS ON CHEMICAL ABORTION & THE ENVIRONMENT. 

CLICK HERE TO READ HAWKINS’ OP-ED at the National Review detailing how the pills can lead to injury, infertility, and even death to mothers as well as to the preborn.  

Regarding SFLAction’s campaign to protect the environment from chemically tainted blood, tissue, and human remains, it’s important to note that  deliberately caused Chemical Abortion is vastly different from a spontaneous abortion, in the following ways: 

  1. Dangerous Chemical Abortion Pills do not taint the remains of spontaneous abortions (miscarriages), which are also not planned events.
  2. Responsibility for protecting the environment from a business practice is with the person/business who began a chain of events leading to potential harms. The Chemical Abortion sales team and corporations, as the generators of medical waste, are responsible to clean it up.
  3. A Chemical Abortion Sales Team knows that they are starting a chain of events likely to ending with tainted tissue and blood and human remains in the wastewater system, and therefore are responsible to ensure protection of the environment.

To learn more about Chemical Abortion, go to This Is Chemical Abortion. 

For an overview of where Students for Life Action worked to pass Chemical Abortion pill legislation in the last two sessions, click here. 

For more on abortion as a federal issue, click here to read Hawkins’ recent letter to Congress. 

For interviews, contact Kristi Hamrick at [email protected]

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Students for Life Action (SFLAction), a 501c4, along with its 501c3 sister organization, Students for Life of America (SFLA), make up the nation’s largest pro-life youth organization and a political and policy operation engaging people of all ages. Together they work to end abortion — the human rights issue of our day — and provide political, legal, and community support for women and their children, born and preborn. Headquartered in Fredericksburg, VA, SFLA has more than 1,300 groups on middlehigh school, college, university, medical, and law school campuses in all 50 states. SFLA creates strategy, policy, and programming to connect those most targeted for abortion with people ready to help and builds a framework for political engagement on their behalf. SFLA and SFLAction have more conversations with those most targeted by the abortion industry than any other pro-life outreach in the world, reaching more than 2 million people across social media platforms each week and engaging in approximately 100,000 digital conversations per month. Over more than 16 years, President Kristan Hawkins has grown SFLAction/SFLA into an $18 million organization preparing for a Post-Roe America.