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US: FDA allows pharmacies to sell abortion pills

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US: FDA allows pharmacies to sell abortion pills

The U.S. Food and Drug Administration (FDA) will allow pharmacies to offer abortion pills for the first time in the United States, the agency said Tuesday as many states seek to ban medical abortions.

The change will potentially expand access to abortion as President Joe Biden’s administration fights to protect abortion rights after they were severely curtailed by the Supreme Court’s decision to overturn the landmark Roe v. Wade ruling and subsequent bans.

Pharmacies can start applying for certification to dispense mifepristone tablets from one of the two companies that make them and, if certified, can dispense them directly to patients once they receive a prescription from a certified physician.

The FDA first said it would make these changes in December 2021 when it announced it would loosen some risk assessment and risk mitigation strategies for pills that have been in place since the agency approved them in 2000 and were temporarily discontinued in 2021 year due to the COVID-19 pandemic.

The changes included permanent removal of restrictions on mail-order pills and online prescriptions.

The agency completed the changes on Tuesday after reviewing additional filings from Danco Laboratories and GenBioPro, two companies that make the drug in the United States.

Mifeprex is a commercial version of mifepristone that, when combined with a second drug called misoprostol, which has a number of uses including the treatment of miscarriage, induces an abortion up to 10 weeks of gestation in a process known as medical abortion.

Abortion rights activists say the pill has long been safe and effective, with no risk of overdose or addiction. In many countries, including India and Mexico, women can buy them without a prescription to induce an abortion.

However, regulatory changes will not ensure equal access for all people, GenBioPro, which makes a generic version of mifepristone, said in a statement.

Abortion bans, some of which involve mifepristone, went into effect in more than 12 states after the U.S. Supreme Court overturned the constitutional right to terminate a pregnancy, overturning the 1973 Roe v. Wade ruling last year.

Women in these states could potentially travel to other states to have medical abortions.

Marjorie Dannenfelser, president of the anti-abortion group SBA Pro-Life America, said the FDA’s latest move jeopardizes the safety of women and the lives of unborn children.

“State legislators and Congress must be a bulwark against the pro-abortion extremism of the Biden administration,” the statement said.

FDA records show a small number of deaths associated with mifepristone. As of June 2021, there have been 26 reported deaths associated with the pill among the approximately 4.9 million people who have taken the pill since it was approved in September 2000.

Pharmacies will have to weigh whether to offer the pill given the political controversy surrounding abortion and determine where they can do so.

However, while these pills may represent a small percentage of a pharmacy’s sales, they can have a big impact on its social status. Public opinion and a highly polarized political landscape can also influence the drugstore’s decision.

In about half of the states, bans or restrictions on abortion can make it illegal or very difficult for pharmacies to provide abortion pills. However, in states where abortion remains legal, pharmacies may face consumer demand for the drug or pressure from abortion rights advocates and healthcare providers.

However, the response from supporters on both sides of the abortion debate reflects the country’s deep divisions.

According to Reuters, New York Times

Author: newsroom

Source: Kathimerini

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