Retaliation from the Biden Administration pursuing wider access to Abortion Pill

Exodus 18:21 “Moreover, look for able men from all the people, men who fear God, who are trustworthy and hate a bribe, and place such men over the people as chiefs of thousands, of hundreds, of fifties, and of tens.

Important Takeaways:

  • Biden Admin Aims to Make Abortion Pill Access Easier in Retaliation to Groundbreaking Roe v. Wade Decision
  • Following the overturning of Roe v. Wade, the Department of Health and Human Services (DHHS) unveiled details Tuesday to increase forms of abortion access.
  • DHHS announced that its intention is to “ensure access to medication abortion” by examining its authority under the Emergency Medical Treatment and Active Labor Act.
  • Treasury Secretary Janet Yellen told senators that taking away access to abortion would further hurt our economy and the labor force.

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U.S. FDA to allow abortion pill by mail permanently

NEW YORK (Reuters) -The U.S. Food and Drug Administration on Thursday said that it would permanently ease restrictions on a pill used to terminate early pregnancies, making it easier to obtain the medicine through the mail.

The decision comes as the right to obtain an abortion, established in the 1973 Supreme Court ruling Roe v. Wade, hangs in the balance.

As a result of the FDA rule change, patients will no longer need to go to a clinic, medical office or hospital in person to receive the medication, generically known as mifepristone, but can opt to receive the pill through the mail from a certified prescriber or pharmacy.

The change is likely to add to the intense U.S. political debate over abortion. Conservative Supreme Court justices indicated in Dec. 1 oral arguments over an abortion ban in Mississippi at 15-weeks of pregnancy that they are open to either gutting Roe or overturning it entirely. A decision is due by the end of June.

The restrictions on the pill have been in place since the FDA approved the drug in 2000 and were lifted temporarily by the government earlier this year due to the pandemic.

Medication abortion involves two drugs, taken over a day or two. The first, mifepristone, blocks the pregnancy-sustaining hormone progesterone. The second, misoprostol, induces uterine contractions.

(Reporting by Caroline Humer, Editing by Cynthia Osterman)

ACLU sues over FDA restrictions on abortion pill access

FILE PHOTO: A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland August 14, 2012. Picture taken August 14, 2012. REUTERS/Jason Reed

By Nate Raymond

(Reuters) – The American Civil Liberties Union filed a lawsuit on Tuesday seeking to challenge U.S. Food and Drug Administration restrictions that limit the ability of women to access the so-called abortion pill.

The ACLU filed the lawsuit in U.S. District Court in Hawaii to challenge FDA restrictions that limit the dispensing of the pill, Mifeprex, to clinics, medical offices or hospitals rather than retail pharmacies.

The ACLU said that as a result, the FDA’s restrictions delay and in some cases block a woman’s access to abortion by requiring her to be handed Mifeprex by healthcare providers who have arranged to stock it in their facilities.

That is despite the fact that Mifeprex, which can be used for abortions up to 10 weeks into a pregnancy, is considered safe and has been recognized by the FDA itself as providing “meaningful therapeutic benefit,” the lawsuit said.

“The unique and harmful restrictions the FDA imposes on where and how a patient may receive Mifeprex deny women meaningful access to this safe and effective treatment with no medical justification,” the complaint said.

The FDA declined to comment.

Mifeprex, manufactured by Danco Laboratories, was approved in 2000 to terminate early pregnancy when given in combination with misoprostol, an anti-inflammatory drug that was originally approved to prevent gastric ulcers.

The lawsuit came after the FDA in March 2016 announced a decision to relax restrictions on the use of Mifeprex that were in place for over a decade.

The FDA eased access to it by updating the prescribing information on the drug’s label, thus expanding use to 70 days of gestation from 49 days, cutting the recommended dose of the drug and reducing the number of required visits to a doctor.

The ACLU filed its lawsuit on behalf of three healthcare associations and a family medicine doctor, Graham Chelius, who is based on the Hawaiian island of Kauai, which has no abortion providers.

According to the ACLU, while Chelius is qualified and willing to provide the pill, he cannot stock it at the hospital where he works due to objections from some colleagues and as a result his patients must fly to another island for abortions.

To support its case, the ACLU cited a June 2016 U.S. Supreme Court ruling that struck down a Texas abortion law imposing strict regulations on doctors and facilities.

(Reporting by Nate Raymond in Boston; Editing by Jonathan Oatis)

Exclusive: Abortion by prescription now rivals surgery for U.S. women

By Jilian Mincer

NEW YORK (Reuters) – American women are ending pregnancies with medication almost as often as with surgery, marking a turning point for abortion in the United States, data reviewed by Reuters shows.

The watershed comes amid an overall decline in abortion, a choice that remains politically charged in the United States, sparking a fiery exchange in the final debate between presidential nominees Hillary Clinton and Donald Trump.

When the two medications used to induce abortion won U.S. approval 16 years ago, the method was expected to quickly overtake the surgical option, as it has in much of Europe. But U.S. abortion opponents persuaded lawmakers in many states to put restrictions on their use.

Although many limitations remain, innovative dispensing efforts in some states, restricted access to surgical abortions in others and greater awareness boosted medication abortions to 43 percent of pregnancy terminations at Planned Parenthood clinics, the nation’s single largest provider, in 2014, up from 35 percent in 2010, according to previously unreported figures from the nonprofit.

The national rate is likely even higher now because of new federal prescribing guidelines that took effect in March. In three states most impacted by that change – Ohio, Texas and North Dakota – demand for medication abortions tripled in the last several months to as much as 30 percent of all procedures in some clinics, according to data gathered by Reuters from clinics, state health departments and Planned Parenthood affiliates.

Among states with few or no restrictions, medication abortions comprise a greater share, up to 55 percent in Michigan and 64 percent in Iowa.

Denise Hill, an Ohio mother who works full time and is pursuing a college degree, is part of the shift.

Hill, 26, became extremely ill with her third pregnancy, sidelined by low blood pressure that made it challenging to care for her son and daughter. In July, eight weeks in, she said she made the difficult decision to have a medication abortion. She called the option that was not available in her state four months earlier “a blessing.”

The new prescribing guidelines were sought by privately-held Danco Laboratories, the sole maker of the pills for the U.S. market. Spokeswoman Abby Long said sales have since surged to the extent that medication abortion now is “a second option and fairly equal” to the surgical procedure.

“We have been growing steadily year over year, and definitely the growth is larger this year,” Long said.

Women who ask for the medication prefer it because they can end a pregnancy at home, with a partner, in a manner more like a miscarriage, said Tammi Kromenaker, director of the Red River Women’s Clinic in Fargo, North Dakota.

GAME CHANGER

Medication abortion involves two drugs, taken over a day or two. The first, mifepristone, blocks the pregnancy sustaining hormone progesterone. The second, misoprostol, induces uterine contractions. Studies have shown medical abortions are effective up to 95 percent of the time.

Approved in France in 1988, the abortion pill was supposed to be a game changer, a convenient and private way to end pregnancy. In Western Europe, medication abortion is more common, accounting for 91 percent of pregnancy terminations in Finland, the highest rate, followed by Scotland at 80 percent, according to the Guttmacher Institute, a nonprofit research organization that supports abortion rights.

In the United States, proponents had hoped the medication would allow women to avoid the clinics that had long been targets of protests and sometimes violence.

But Planned Parenthood and other clinics remain key venues for the medication option. Of the more than 2.75 million U.S. women who have used abortion pills since they were approved in 2000, at least 1 million got them at Planned Parenthood.

Many private physicians have avoided prescribing the pills, in part out of concern that it would expose their practices to the type of protests clinics experienced, say doctors, abortion providers and healthcare organizations.

At the same time, the overall U.S. abortion rate has dropped to a low of 16.9 terminations per 1,000 women aged 15-44 in 2011, down from 19.4 per 1,000 in 2008, according to federal data. The decline has been driven in part by wider use of birth control, including long lasting IUDs.

In March, the U.S. Food and Drug Administration changed its prescribing guidelines for medication abortion. The agency now allows the pills to be prescribed as far as 10 weeks into pregnancy, up from seven. It cut the number of required medical visits and allowed trained professionals other than physicians, including nurse practitioners, to dispense the pills. It also changed dosing guidelines.

The changes were supported by years of prescribing data and reflect practices already common in most states where doctors are free to prescribe as they deem best.

Ohio, Texas and North Dakota took the unusual step of requiring physicians to strictly adhere to the original guidelines. Many abortion providers were reluctant to prescribe the pills under the older guidelines, which no longer reflected current medical knowledge, said Vicki Saporta, President and CEO of the National Abortion Federation.

Randall K. O’Bannon, a director at the anti-abortion National Right to Life organization, criticized the new guidelines but said his organization had no plans to fight them.

“What they did was make it more profitable,” O’Bannon said. “It will increase the pool of potential customers.”

Planned Parenthood said both types of abortion typically cost from $300 to $1,000, including tests and examinations. The group charges a sliding fee based on a patient’s ability to pay, regardless of which type of abortion they choose.

VARIED ACCESS

Despite a landmark U.S. Supreme Court ruling that abortion is a woman’s right, access varies widely by state. Some states maintain restrictions on both surgical and medication abortions; others have worked to increase access.

In rural Iowa, where clinics are few and far between, Planned Parenthood is using video conferencing, known as telemedicine, to expand access.

The way it works is, a woman is examined in her community by a trained medical professional, who checks vital signs and blood pressure and performs an ultrasound. The information is sent to an off-site doctor, who talks with the woman via video conference and authorizes the medications.

Since the telemedicine program began in Iowa in 2008, medication abortions increased to 64 percent of all pregnancy terminations, the highest U.S. rate.

In New York, Hawaii, Washington and Oregon, a private research institute, Gynuity Health Projects, works with clinics to send abortion pills by mail to pre-screened women.

“Medication abortion is definitely the next frontier,” said Gloria Totten, president of the Public Leadership Institute, a nonprofit that advises advocates.

And in Maryland and Atlanta, the nonprofit organization Carafem opened centers in the last 18 months that offer birth control and medication, but not surgical, abortions. It promotes its services with ads that read: “Abortion. Yeah, we do that.”

(Reporting By Jilian Mincer; Editing by Michele Gershberg and Lisa Girion)

FDA backs expanded use of medical abortion pill

WASHINGTON (Reuters) – The U.S. Food and Drug Administration on Wednesday agreed to allow more access to Danco Laboratories’ abortion pill Mifeprex, likely making it easier and cheaper for women to have an abortion by medication.

The FDA increased authorized use of the pill to 70 days of gestation from the current 49 days, cut the recommended dose of the drug and reduced the number of required visits to a doctor.

The changes are expected to allow greater access to medication abortions, particularly in Texas, North Dakota and Ohio, which have laws that require providers to prescribe the drug according to a more restrictive FDA label in place since 2000.

On Wednesday, the agency updated the Mifepfrex requirements to bring them in line with the most up-to-date scientific studies, which have shown that a third of the dose works as well.

“The FDA label has finally caught up to the evidence based practice in the United States,” said Vicki Saporta, president and chief executive of the National Abortion Federation, an organization of abortion providers. “It has the potential of opening medical abortion care in more rural areas because it does not have to be given by a surgical abortion provider,” she added.

The FDA decision comes amid a heated 2016 presidential race.

Earlier this month, the Supreme Court took up a major abortion case which represents a test for a strategic shift that abortion opponents have taken in recent years: to apply restrictive regulations to abortion doctors and facilities rather than try to ban the procedure outright.

Mifeprex was approved in 2000 to terminate early pregnancy when given in combination with misoprostol, an anti-inflammatory drug that was originally approved to prevent gastric ulcers.

Under the new prescription information on the label, patients will take one 200 mg tablet of Mifeprex on day one instead of three 200 mg tablets. They will take 800 mcg of misoprostol 24-48 hours after taking Mifeprex. Previously they took 400 mcg on day three.

Under the old label, patients were asked to return to their doctor 14 days after taking Mifeprex for an examination. The new label requires that they return between seven and 14 days for an “assessment.”

As far back as 2001, an estimated 83 percent of U.S. providers were no longer using the old FDA-approved regimen, according to the Guttmacher Institute, which backs abortion rights but whose research is used by both sides of the debate.

(Reporting by Toni Clarke, Jilian Mincer and Jon Herskovitz; Editing by Alistair Bell)

Supreme Court Justice Grants Abortion Pill Relief

A Supreme Court justice has given temporary relief to two religious groups that objected to the compromise to the abortion pill mandate in the Affordable Care Act.

Geneva College of Beaver Falls, Pennsylvania and the Roman Catholic dioceses in Erie and Pittsburgh along with their affiliated organizations.  The groups sued the Obama administration because the so-called “compromise” still required them to provide abortion-inducing drugs.

The University of Notre Dame had previously filed a lawsuit over the same issue.

“Signing such a form or letter facilitates moral evil,” the groups wrote in legal briefs. “This is true whether or not applicants pay for the objectionable coverage.”

Supreme Court Justice Samuel Alito granted temporary relief and ordered the Obama administration to respond to the appeal by Monday.

The Supreme Court has already remanded the Notre Dame ruling to the 7th Circuit Court of Appeals to be reconsidered in light of the 2014 Hobby Lobby stations.