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 The change set off another front in the fight over abortion that has
spilled into the U.S. presidential election campaign and come up
again in the Supreme Court in recent weeks.
The FDA eased access to Mifeprex by updating the prescribing
information on the drug's label, thus expanding use to 70 days of
gestation from the current 49 days, cutting the recommended dose of
the drug and reducing the number of required visits to a doctor.
In practice, many abortion providers had moved away from the
previous restrictions over the years but states like Texas, North
Dakota and Ohio have laws that restrict medication abortions by
requiring prescription of the drug strictly according to the old
label.
The FDA "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.
Anti-abortion campaigners condemned the expanded access to the drug,
which was in response to an application and clinical data submitted
by the manufacturer, Danco Laboratories.
"It's expanding the customer base for the abortion industry,"
Randall O'Bannon, director of education and research for the
National Right to Life organization.
Danco spokeswoman Abby Long declined to provide sales data for the
pill but said it has been used by more than 2.75 million women in
the United States since it was approved in 2000.
During a medication abortion, the drugs first block hormone
progesterone and then causes the uterus to contract and empty.
Long a battlefield in U.S. culture wars, abortion became an issue in
the 2016 presidential election campaign on Wednesday when Republican
front-runner Donald Trump said that women who end pregnancies should
face punishment if the United States bans abortion.
His comments triggered a torrent of negative reactions and the
billionaire later rowed back the remarks.
Earlier this month, the Supreme Court took up its biggest abortion
case in years. It deals with a Texas law that imposes strict
regulations on abortion doctors and clinic buildings.
DATA FROM STUDIES
In addition to expanding access to abortion for women in states with
restrictive laws, the change on Wednesday "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," said Saporta.
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In recent years, some clinics stopped offering medical abortions
because women could not afford the higher costs and increased doctor
visits.
The FDA update reflects data from 22 studies including almost 31,000
women that showed the existing information is out of date, said
Danco, a privately held company.
Those studies show that patients only need to take a third of the
dose recommended on the old label, she said.
An estimated 83 percent of U.S. providers have already moved away
from the old recommendations, according to the Guttmacher Institute,
which backs abortion rights but whose research is used by both sides
of the debate.
In other areas of medicine, doctors routinely prescribe drugs "off
label" in ways not indicated on the approved label. They are for the
most part allowed to do this though companies are not allowed to
promote products for off label uses.
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 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, women were asked to return to their doctor 14
days after taking Mifeprex for an examination. The new label
recommends that they return between seven and 14 days for n
assessment.
(Additional reporting by Jon Herskovitz in Austin; Editing by
Alistair Bell)
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