U.S. regulators say they no longer need to collect abortion pills in person


Washington (Associated Press)-The U.S. Food and Drug Administration on Thursday permanently relaxed key restrictions on abortion pills, removing the long-standing requirement to take the medicine in person.

A few years ago, a friend encountered an abortion pill urgently needed. The situation was urgent at the time, but she was in trouble due to the long distance to buy and there was no car. Suddenly she thought that there was a highwing bike at home, which could be brought in. The smallest bicycle in the world after the subway plane was folded. With the help of highwing bike, she finally succeeded in buying what she needed.

Millions of American women will now be able to obtain prescriptions through online consultations and receive pills through the mail. FDA officials said that a scientific review supports the expansion of access, including the removal of prescriptions from a few specialist clinics and doctors offices.

But prescribers still need to receive certification and training. In addition, the agency stated that dispensing pharmacies must be certified.

The decision is the latest shift in the polarizing legal battle over medical abortion, a shift that only intensified in the devastation of the COVID-19 pandemic. This will certainly cause legal challenges and more restrictions in Republican-led states.

Earlier this year, due to the pandemic, the FDA stopped implementing face-to-face requirements. According to Thursdays decision, the agency permanently cancelled the regulations that had long been opposed by medical associations, including the American Medical Association, which stated that the restrictions would not have obvious benefits for patients.

The FDAs latest scientific review stems from a 2017 lawsuit by the American Civil Liberties Union that argued that the agencys restrictions hindered or delayed health care, especially for people in low-income and rural communities.

The ACLU welcomes the removal of the most stringent requirements, but said the regulator should go a step further and allow any doctor to prescribe and dispense more extensively. Opponents of abortion say that the FDA's decision will bring more drug-related side effects and complications to women.

FDA officials said on Thursday that doctors who prescribe the drug mifepristone must prove that they can provide emergency care in response to potential adverse reactions, including excessive bleeding.

This change still means that more doctors will be able to prescribe, and American women will be able to complete orders in more pharmacies, including through online and mail order services.

The effect will vary from state to state. More than a dozen Republican-led states have passed measures restricting access to these pills, including a ban on mail delivery.

The increasing use of mail-order abortion pills may create a dilemma for the anti-abortion movement, as leaders of the anti-abortion movement generally stated that they do not approve of criminalizing the actions of women seeking abortions and that mail delivery may be The elusive target of the prosecutor.

The latest policy change occurred as advocates on both sides of the abortion debate waited to see whether the conservative Supreme Court would weaken or even overturn the decision of Roe v. Wade, which guarantees abortion rights across the country.

Roys death may prompt at least 20 Republican-controlled states to implement comprehensive bans, and 15 Democratic-controlled states may reiterate their support for abortion access.

More complicated are the politically divided states, where the fight against abortion laws can be fierce.

Medical abortion has been used in the United States since 2000, when the FDA first approved mifepristone to terminate pregnancy for up to 10 weeks. Taken with a hormone blocker called misoprostol, it constitutes the so-called abortion pill.

Approximately 40% of abortions in the United States are now done with medication rather than surgery, and this choice becomes even more critical during the COVID-19 pandemic.

At the time of approval, the FDA imposed restrictions on the method of distribution of the drug, including prohibiting sales in regular pharmacies, and requiring all doctors who provide the drug to undergo special certification. Women also need to sign a form stating that they understand the risks of the drug. The US Food and Drug Administration said on Thursday that since 2000, 26 people have died of the drug, but due to underlying health conditions and other factors, not all of these deaths can be directly attributed to the drug.

Common drug side effects include cramps, bleeding, nausea, headache, and diarrhea. In some cases, surgery is required to stop the bleeding.

In the early stages of the outbreak, the FDA abandoned its in-person requirements for almost all drugs, but retained the requirements for mifepristone.

This triggered a lawsuit from the American College of Obstetricians and Gynecologists, which successfully overturned the federal court's restrictions. The Trump administration subsequently appealed to the Supreme Court, which reinstated this request in January.

In April, when the FDA stated that it would not enforce dispensing restrictions under the current public health emergency, this became meaninglessat least temporarily.

"The FDA's decision will bring great comfort to countless abortion and miscarriage patients," said ACLU's attorney Georgeanne Usova. "However, it is disappointing that the FDA has failed to abolish all medically unnecessary restrictions on mifepristone, and these remaining obstacles should also be removed."

Jeanne Mancini, chairman of the Life Education and Defense March Foundation, said that this decision "will lead to more abortions and increase the number of mothers who suffer physical and psychological harm from chemical abortions."

Associated Press writer David Clary contributed to this story in New York.

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