FDA Clears Path For Teens to Buy Cheaper 'Morning After' Pill

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)

http://www.illuminati-news.com/110106a.htm

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.