Battleground Against Medical Abortion: Lawsuit Challenges FDA's Drug Review Process

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The future of medical abortion is teetering in lawsuits over the availability and legality of mifepristone, the first of two drugs used in the procedure.

End of February, attorneys general from a dozen Democratic-led states sued the U.S. Food and Drug Administration over regulations they say are medically unnecessary and intended to make it harder to obtain mifepristone. The FDA has relaxed some of the restrictions over the past two years, but a prescription for mifepristone still has many qualifications as part of an assessment risk mitigation strategy, aka REMS.

But others claim the FDA’s rules aren’t strict enough. Mifepristone’s ability to stay on the US market could depend on the ruling of a judge in Texas, which has already banned abortion for the state. with some exceptions, and the decision could take place any day. In part, the lawsuit claims the FDA never had the right to approve mifepristone in the first place, and it questions the drug’s safety despite medical organizations continuing to maintain it as safe. If the judge agrees, the case has the potential to ban mifepristone and change the way medical abortion is performed even in States where abortion is legalalthough a cascade of other legal proceedings and appeals should follow immediately.

Medical abortions are generally limited to the first trimester of pregnancy and represent a growing number of total abortions in the United States – currently more than half. Medical organizations, including the American Medical Association and the American College of Obstetricians of Gynecologists say mifepristone is safe. Patients may choose medical abortion because it is done in the privacy of their home and may be more accessible or less expensive than the clinic procedure. After the United States Supreme Court overturned Roe. v. Wade last spring, restricting abortion pills became a priority for lawmakers trying to ban or limit abortion.

Whatever the Texas judge decides, a series of appeals and other court rulings are expected to follow, making it difficult to say for sure what will happen to mifepristone. Health care providers and legal experts say it fits the course post-Roe v. Wade, when the future and legality of drugs used during pregnancy and abortion depend on state actors and the courts.

But in the case of Texas, in particular, the FDA approval process is in question. If the judge revokes the agency’s 20-plus-year seal of approval for a drug, it would overrule The FDA’s own calculations of a drug’s benefits and risks – A “unprecedented“an evolution in drug regulation in the United States, according to an article in the New England Journal of Medicine. Even if mifepristone remains on the market, the case has opened the door to the potential withdrawal of other drugs and drugs from the market , whatever the medical treatment the consensus is.

What is mifepristone and what is the Texas case about?

Mifepristone is a drug used in medicines first trimester abortions as well as early treatment for miscarriages. It temporarily blocks progesterone, a hormone needed to maintain and develop pregnancy. Patients who use it for abortion take it before misoprostol, a drug that induces uterine contractions, to initiate termination of pregnancy. Patients who have had a miscarriage could also take it to help their body stop behaving like pregnant when the pregnancy is no longer viable and the embryo or fetus has stopped developing.

On its own, mifepristone alone is not particularly effective in terminating a pregnancy, which is why the FDA approved it specifically for use with misoprostol, a drug originally intended for stomach ulcers and other health conditions. Misoprostol is technically used off-label for induced abortion (usually just “abortion”) or spontaneous abortion (miscarriage).

Mifepristone has been in the limelight in abortion debates because its sole purpose and endorsement is the termination of pregnancy.

Plaintiffs in the Texas case include the Hippocratic Alliance for Medicine, a health care group against abortion and similar socially but medically based issues, such as physician-assisted suicide. The lawsuit claims that the FDA never had the authority to approve mifepristone and that it has harmful side effects. The suit also disputes pregnancy as a disease, and the FDA regulates mifepristone as if it were. The actual threat to the future of mifepristone in the market depends on a few factors.

Impact on FDA drug regulations

“If the court decides against the FDA, part of the magnitude of the threat depends on how the opinion is written,” I. Glenn Cohen, Harvard law professor and faculty director of the Petrie-Flom Center for Health Law Policy from the school, said in an email. Cohen is also a signatory to an amicus brief from an FDA legal expert for the Texas case and author of an article on the case published in the New England Journal of Medicine. An opinion could be narrower and focused on pregnancy, or it could be written broadly, Cohen said. If broad, it has the potential to influence decisions about other medications for other health conditions. But that would trigger a lengthy process involving the Justice Department and other factors, Cohen said.

Cohen added that nationwide injunctions that “essentially allow a single district court judge anywhere in the country to make a decision for the whole country” have drawn a lot of skepticism, including from two conservative Supreme Court justices.

If the judge rules in favor of the Hippocratic Medicine Alliance and revokes the FDA’s 20-plus-year seal of approval, that would void the Advantages of FDA over risk calculations. For a judge to circumvent this “congression-created process” in drug regulation would be unprecedented, Cohen and the other authors write in the paper. The scope of the injunction – whether mifepristone is banned nationally – would have to be determined by other courts, and such a decision has the potential to go all the way to the Supreme Court.

Not only could the way the FDA assesses the benefits and risks of drugs be changed, but the door to the courtroom would be opened to removing other drugs from the market besides those used during pregnancy or abortion. , including vaccines and gender-affirming drugs that have been politicized by lawmakers. And like reported in Slatethe fate of medical abortion also depends on the power the FDA has and how it uses its discretion.

But the FDA is not the last frontier in trying to stop medical abortions. Also in Texas, lawmakers last week introduced a bill to block websites with information about abortion drugs or sites where people can find the pills, which would include overseas pharmacies like AidAccess. Even in states where abortion is currently banned, people can order pills from these sites because they are not regulated by the FDA.

Sarah Silbiger/Getty Images

Medical abortions can continue with misoprostol only

Misoprostol alone is the other recommended method of medical abortionand may already be a go-to regimen for many people in non-affluent countries who do not have access to mifepristone.

It is expected that many healthcare providers will continue to prescribe misoprostol for medical abortions where abortion is legal, including online. Monica Cepak, marketing director of the sexual and reproductive telemedicine site Strandsaid misoprostol would still be available to patients in case mifepristone was banned.

And despite the results of ongoing trials, medical abortion pills will still be available in foreign pharmacies like HelpAccessand surgical abortion will remain an option where state laws permit.

But while studies show misoprostol alone is effective on its own in terminating a pregnancy, it is not exactly as effective as the mifepristone-misoprostol combination and may cause more pain and side effects, including the need for follow-up emergency care if the body of someone’s not having a successful pregnancy, says Dr. Glenmarie Matthews, OB-GYN and assistant professor at Robert Wood Johnson Medical School at Rutgers. She says a call to ban mifepristone simply takes a safe procedure and makes it less safe.

Will providers still be comfortable offering misoprostol-only abortions?

“It’s not about feeling comfortable,” Matthews said. “We will always have to do medical abortion with misoprostol because women will always need medical abortion.”

Even if the Texas judge doesn’t rule in a way that blocks mifepristone nationwide, lawsuits like this still affect abortion because they add stigma, according to Dr. Jennifer Lincoln, OB-GYN at Portland, Oregon, and director of Mayday.Health.

“It just further restricts and adds unnecessary shame and stigma to drugs that have over 20 years of completely safe data,” Lincoln said, adding that medicated abortion pills “send fewer people to the hospital than the Tylenol and Viagra”.

Matthews says the ban on medical abortion increases existing gaps in access to health care in the United States.

“Of course, people of color and lower socioeconomic status will again be more affected because they are the ones who will not have the resources to get their medications,” Matthews said, referring to the existing burden of getting misoprostol from pharmacies that may already be reluctant to give misoprostol to pregnant women.

The United States has the highest maternal mortality rate of any rich country. black women are about three times more likely die during pregnancy, childbirth or the postpartum period.

The information in this article is for educational and informational purposes only and is not intended to constitute medical or health advice. Always consult a physician or other qualified health care provider with any questions you may have about a medical condition or health goals.

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Anyone can Create a new Facebook account. if you want Create a Facebook account
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How to Create a Facebook Account Without a Phone Number in the next paragraph.
How to Create a New Facebook Account Without a Phone Number
necessary process Create a Facebook account
Not tied to a phone number You have an Android phone and it just needs
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Access the Google Play Store.

Find Facebook Lite Facebook.

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Click to register via email.

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There are many ways To create a Facebook account
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Activating a Facebook account with a fake number has disadvantages and
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If you are new to this social networking platform then… Create a Facebook profile It can be stressful for you. So here are some tips to help you get started with Facebook:

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you signed up for a Facebook account via email, you’ll need to contact
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if you want it now Create a new Facebook account Using your phone number instead of your email address, you need to follow these steps:

Go to and click Create New Account.

Enter your telephone number and other personal information requested in the “Registration” form; Click “Login” when finished.

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Here we will learn how to create a new Facebook gmail account on computer, and here are the necessary steps:

Turn on the computer and launch the browser.

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Your first and middle name.

Your gmail (which we created earlier).

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After completing these steps, you have to click on Create a Facebook account.

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you have to do is go to your email inbox and you will find a message
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Create a Facebook account on your phone
When using your phone to create a new Facebook Gmail account, you must first Download the Facebook app from Google Play
If you are using a phone with limited specs, not enough storage space
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Open the Facebook app.

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