Federal Judge: Women Can Get Abortion Pill Without In-Person Doctor Visit During Pandemic

(SILVER SPRING, Md.) — A federal judge agreed Monday to suspend a rule that requires women during the COVID-19 pandemic to visit a hospital, clinic or medical office to obtain an abortion pill. U.S. District Judge Theodore Chuang in Maryland concluded that the “in-person requirements” for patients seeking medication abortion care impose a “substantial obstacle”…

Federal Judge: Women Can Get Abortion Pill Without In-Person Doctor Visit During Pandemic

(SILVER SPRING, Md.) — A federal judge agreed Monday to suspend a rule that requires women during the COVID-19 pandemic to visit a hospital, clinic or medical office to obtain an abortion pill.

U.S. District Judge Theodore Chuang in Maryland concluded that the “in-person requirements” for patients seeking medication abortion care impose a “substantial obstacle” to abortion patients and are likely unconstitutional under the circumstances of the pandemic.

“Particularly in light of the limited timeframe during which a medication abortion or any abortion must occur, such infringement on the right to an abortion would constitute irreparable harm,” the judge wrote in his 80-page decision.

Chuang’s ruling will allow healthcare providers to arrange for mifepristone to be mailed or delivered to patients during the public health emergency declared by the secretary of the U.S. Department of Health and Human Services. The U.S. Food and Drug Administration approved mifepristone to be used in combination with a second drug, misoprostol, to end an early pregnancy or manage a miscarriage.

Read more: How Anti-Abortion Activists Are Taking Advantage of the Coronavirus Crisis

“By causing certain patients to decide between forgoing or substantially delaying abortion care, or risking exposure to COVID-19 for themselves, their children, and family members, the In-Person Requirements present a serious burden to many abortion patients,” Chuang wrote.

The American College of Obstetricians and Gynecologists and other groups sued HHS and the FDA in May to challenge the rule.

Skye Perryman, chief legal officer for the American College of Obstetricians and Gynecologists, said the FDA’s restrictions on mifepristone are not medically necessary and “do not advance the health and safety of patients.”

“Today’s ruling recognizes the hardship and undue burden that many women have faced obtaining essential health care during the COVID-19 pandemic,” Perryman said.

Plaintiffs’ attorneys from the American Civil Liberties Union argued that the FDA’s in-person requirements infringe on a woman’s constitutional rights to an abortion and violates the due process clause of the Fifth Amendment.

Government lawyers have argued that the requirements are necessary to ensure that patients safely use mifepristone.

The judge said suspending the requirements aligns with public health guidance to eliminate unnecessary travel and in-person contact.

Chuang granted the ACLU’s request for a preliminary injunction on due process grounds. He noted that federal regulators have waived in-person requirements for many other drugs “for the specific purpose of protecting public health.”

The group’s lawsuit says mifepristone is the only one of more than 20,000 FDA-regulated drugs that patients must receive in person at a hospital, clinic, or medical office “yet may self-administer, unsupervised, at a location of their choosing.”

The judge didn’t set any geographic limitations on the injunction. Referring to the nature of the pandemic, he said that “crafting relief that attempts to account for both the unpredictable changes and nuanced regional differences across 50 different states over an extended period of time is simply infeasible.”

Read more: No Test, Minimal Contact: How One Abortion Clinic Is Adapting to Coronavirus Concerns

More than 4 million people in the U.S. have used mifepristone and misoprostol to end an early pregnancy; the two-drug combination accounted for 39% of all U.S. abortions in 2017, the lawsuit says.

The lawsuit says the FDA rule has “particularly severe implications for low-income people and people of color, who comprise a disproportionate share of impacted patients and who are already suffering and dying from COVID-19 at substantially higher rates.”

In March, dozens of anti-abortion advocates signed a letter to HHS Secretary Alex Azar in which they called for halting abortion procedures during the pandemic. “Their continued operation depletes sorely needed personal protective equipment and leads to complications that will further overwhelm already overextended emergency rooms,” the letter said.

Azar and FDA Commissioner Stephen Hahn also were named as defendants in the suit.

Source : Time More   

What's Your Reaction?

like
0
dislike
0
love
0
funny
0
angry
0
sad
0
wow
0

Next Article

A new hormonal therapy for prostate cancer is under expedited FDA review

In June, the US Food and Drug Administration (FDA) launched an accelerated review of a promising new drug for advanced prostate cancer. Called relugolix, it suppresses testosterone and other hormones that speed the cancer’s growth. If approved, this new type of hormonal therapy is expected to set a new standard of care for the disease. […] The post A new hormonal therapy for prostate cancer is under expedited FDA review appeared first on Harvard Health Blog.

A new hormonal therapy for prostate cancer is under expedited FDA review

In June, the US Food and Drug Administration (FDA) launched an accelerated review of a promising new drug for advanced prostate cancer. Called relugolix, it suppresses testosterone and other hormones that speed the cancer’s growth. If approved, this new type of hormonal therapy is expected to set a new standard of care for the disease.

Doctors give hormonal therapies when a man’s tumor is metastasizing (spreading beyond the prostate), or if his PSA levels start rising after surgery or radiation. The most commonly used hormonal therapies, called LHRH agonists, will eventually lower testosterone levels in blood. But that decline happens only after testosterone flares up to high levels as an initial response to treatment. This short-term flare-up, which lasts about a month, can cause bone pain, urinary obstruction, and other symptoms. So, doctors will ordinarily give LHRH agonists together with other drugs that prevent testosterone from interacting with cells in the body.

Alternatively, men can be treated with a different class of hormonal therapies that lower testosterone levels without the initial flare. These drugs are known as GnRH antagonists, and only one is currently available in the United States. Called degarelix, it’s given once a month by injections that can in some instances cause pain, redness, and swelling. (A different injectable GnRH antagonist, called abarelix, was withdrawn from US markets in 2005 after it caused a higher-than-expected increase in allergic reactions.)

Needle-free

Here is where relugolix enters the picture: it’s also a GnRH antagonist, but rather than being given by monthly injections, it’s taken as a daily pill.

The FDA was prompted to speed the drug’s review based on its superior performance during a late-stage clinical trial. The study investigators enrolled 934 men from 155 hospitals in the United States and Japan. Half the men had elevated PSA levels after having been treated already for prostate cancer. The rest had newly diagnosed metastatic cancer, or more localized prostate tumors that weren’t suitable for surgery. A total of 622 were treated with relugolix, and 305 men were given an LHRH agonist called leuprolide. All the men were treated for 48 weeks.

By all measures, relugolix came out ahead. The drug lowered testosterone to acceptable therapeutic levels within four days, whereas in the leuprolide-treated men, testosterone initially surged to an average of more than ten times the target concentration before dropping below it 29 days later. Furthermore, normal testosterone levels were restored within 90 days after relugolix treatment was discontinued. By contrast, just 3% of the leuprolide-treated men achieved normal testosterone levels within that same duration after treatment. That testosterone levels go back to normal after hormonal therapy is important for quality of life, including among men who receive the treatment intermittently.

Dr. Marc Garnick, Gorman Brothers Professor of Medicine at Harvard Medical School and Beth Israel Deaconess Medical Center, and editor in chief of HarvardProstateKnowledge.org, points out that relugolix also had a better safety profile for measures of heart health. It’s long been known that hormonal therapy in general can have cardiac toxicities, especially among men with pre-existing risk factors such as diabetes, hypertension, or a prior heart attack. But during this clinical trial, fewer men in the relugolix group experienced significant cardiac side effects after 48 weeks of treatment.

“This is an important study, as it demonstrates the ability of a GnRH antagonist to be administered as an oral drug,” Garnick said. “The continued development of GnRH antagonists has many advantages compared to drugs that require an obligatory increase in testosterone before achieving their desired effects. The oral availability of relugolix may also lessen some of the local skin reactions that are common with degarelix, or some of the allergic reactions that occurred with abarelix.”

The FDA is expected to make a decision on the drug’s approval by December 20, 2020.

Disclosure: Dr. Garnick has been named as a scientific advisor to Myovant Sciences (the developer of relugolix) and is a shareholder in the company. He was also a developer of abarelix and previously served as an advisor to Ferring Pharmaceuticals, the developer of degarelix.

The post A new hormonal therapy for prostate cancer is under expedited FDA review appeared first on Harvard Health Blog.

Source : Harvard Health More   

This site uses cookies. By continuing to browse the site you are agreeing to our use of cookies.