FDA Clears Path For Teens to Buy Cheaper 'Morning After'
Pill
Monday, 03 Mar 2014 02:09 PM
By Sandy Fitzgerald
http://www.newsmax.com/Newsfront/contraceptive-birth-control-morning-after-pill/2014/03/03/id/555763
Teen girls, no matter their age or
health status, are now able to purchase cheaper, generic versions of Plan B
One-Step and other popular emergency contraceptive pills over the counter and
without their parents' permission.
The Food and Drug Administration has lifted a ban on generic versions
of the pills, NPR reported, adding access to less expensive versions of the
controversial drug.
The FDA last July, following a court order, removed age restrictions on
sales of Plan B One-Step, which prevents most pregnancies in women weighing
less than 165 pounds if it is taken within 72 hours of unprotected sex.
But at that time, while approving
the drug to be sold without a prescription, the FDA had allowed the Plan B maker,
Teva Pharmaceuticals, to be
protected from competing with generic drugmakers in exchange for conducting a
market study on teen use of the emergency contraceptives.
Teva had also contended the
generic version of the drug should not be sold over the counter to people of
any age, but in an 11-page letter to generic competitors last week, Kathleen
Uhl, acting director of the FDA's Office of Generic Drugs, said that Teva's
claim in age restrictions was too broad.
Women's groups had campaigned hard
to make the product more accessible, since the generic version is at least $10
less expensive than the name brand. Plan B One-Step costs about $50, and the
generic versions, Next Choice One Dose and My Way, range from $20 to $35.
However, One Step's label says the
product is recommended for girls 15 and older, while the generic versions say
they should be used by people 17 and older. But no matter what the label,
teenagers will still be able to buy the drug directly without showing proof of
age.
"This is a significant leap
forward in obtaining full, over-the-counter status for emergency contraception,
and we commend the FDA for this decision," said Jessica Arons, president
and CEO of the Reproductive Health Technologies Project. "Everyone
deserves a second chance to get it right."
Erica Jefferson, FDA acting
assistant commissioner for media affairs, told The Boston Globe that once companies submit their revised labeling,
"the agency will work to approve it as soon as possible."
Older emergency contraceptives,
which require that a person take two pills 12 hours apart, will remain behind
the pharmacy counter, where it does not require a prescription but can only be
sold to people age 17 and older and with a valid form of identification.
"This week’s decision means
lower cost emergency contraception will be available to women of all
ages," Martha Walz, president of the Planned
Parenthood League of Massachusetts told The Globe. "As a result, more
women will gain access to emergency contraception, and this should reduce the
number of unintended pregnancies."
But Walz said she's puzzled over
the labeling issue.
"I don’t know why the FDA
would have any differences in labels for a generic," since it’s an
identical product to the brand name, she said. "Young teenagers reading
these labels might be compelled to spend double the amount without realizing
that both products are equally safe and effective."
Not all health professionals are
convinced the drug is safe for teenagers.
Donna J. Harrison, executive
director of the American Association of Pro-Life Obstetricians and
Gynecologists, wrote in an op-ed in The New York Times about CVS' decision to
stop selling tobacco products that the chain will still be selling a dangerous
drug without the need of a prescription by selling emergency contraceptives
over the counter to teenagers.
"The unfettered availability
of emergency contraception raises serious concerns, not least because access to
Plan B does not reduce the number of unintended pregnancies or abortions,"
Harrison wrote.
"Aside from being
ineffective, over-the-counter access to emergency contraceptives is harmful to
women’s health," she continued. "It isolates the most at-risk women,
teenagers, and those in unstable relationships from getting the medical care
they need to diagnose sexually transmitted diseases and access appropriate
contraceptive counseling ... This is not a product to be sold over the counter
with no more consultation than buying M&Ms."
Teva Pharmaceuticals
Phillip
Frost is the chairman for Teva
Pharmaceutical Industries Ltd., and was a regent at the Smithsonian Institution.
Note: Cristian Samper
was the acting secretary for the Smithsonian
Institution, and is a trustee at the Carnegie
Institution for Science.
Andrew Carnegie
was the founder of the Carnegie
Institution for Science, provided seed funding for the International Court of Justice, the founder for the Carnegie Corporation of New York, and the
founder of the Carnegie Endowment for International Peace (think tank).
Hisashi
Owada is a judge for the International
Court of Justice, a director at the Better
World Fund, and a director at the Nuclear
Threat Initiative (think tank).
Ted
Turner is the founder & chairman for the Better World Fund, and a co-chairman for the Nuclear Threat Initiative (think tank).
David A. Hamburg
is the president emeritus for the Carnegie
Corporation of New York, an adviser for the Nuclear Threat Initiative (think tank), and his daughter is Margaret A. Hamburg.
Margaret A.
Hamburg is David A. Hamburg’s
daughter, the VP for the Nuclear Threat
Initiative (think tank), and the commissioner for the U.S. Food and Drug Administration (FDA).
Donald
Kennedy was a commissioner for the U.S.
Food and Drug Administration (FDA), and a trustee at the Carnegie
Endowment for International Peace (think tank).
Foundation
to Promote Open Society was a funder for Carnegie Endowment for
International Peace (think tank), and the Brookings Institution (think
tank).
George Soros
was the chairman for the Foundation to Promote Open Society, and is founder
& chairman for the Open Society
Foundations.
Open
Society Foundations was a funder for the Planned Parenthood Federation of America, and the Carnegie
Endowment for International Peace (think tank).
Carnegie
Endowment for International Peace (think
tank) was a funder for the Nuclear
Threat Initiative (think tank).
Jessica Tuchman Mathews is a director
at the Nuclear Threat Initiative (think
tank), the president of the Carnegie Endowment for International Peace
(think tank), a director at the American Friends of Bilderberg
(think tank), was an honorary trustee at the Brookings Institution (think
tank), and a 2008 Bilderberg conference participant (think tank).
Ed Griffin’s interview with
Norman Dodd in 1982
(The investigation into the
Carnegie Endowment for International Peace uncovered the plans for population
control by involving the United
States in war)
Mark B. McClellan
was a senior fellow at the Brookings Institution (think tank), and a
commissioner for the U.S. Food and Drug
Administration (FDA).
Cass R. Sunstein
is a senior fellow at the Brookings
Institution (think tank), and married to Samantha Power.
Samantha
Power is married to Cass R. Sunstein,
the United Nations U.S. ambassador for the Barack Obama administration, and was a correspondent
for the Boston Globe.
Shirley Ann
Jackson is a trustee at the Brookings Institution (think tank), and
a regent at the Smithsonian Institution.
David M.
Rubenstein is a trustee at the Brookings Institution (think tank), and
a regent at the Smithsonian Institution.
Joseph R. Biden Jr.
is a regent for the Smithsonian
Institution, and the vice president for the Barack Obama administration.
Phillip
Frost was a regent at the Smithsonian
Institution, and is the chairman for Teva
Pharmaceutical Industries Ltd.
Cristian Samper
was the acting secretary for the Smithsonian
Institution, and is a trustee at the Carnegie
Institution for Science.
No comments:
Post a Comment