The Justice Department filed a notice on Wednesday to appeal a court order to remove restrictions on the morning-after pill and provide over-the-counter access to emergency contraception for women and girls of all ages.The Obama administration’s decision to appeal comes despite a recommendation from the Food and Drug Administration to lift age restrictions and other scientific research saying the drug is safe and effective for all ages.As the New York Times reports:The appeal reaffirms an election-year decision by Mr. Obama’s administration to block the drug’s maker from selling it without a prescription or consideration of age, and puts the White House back into the politically charged issue of access to emergency contraception… By appealing the judge’s ruling, Mr. Obama’s Justice Department is essentially renewing the objections that [secretary of health and human services Kathleen Sebelius] — backed by the president — had more than a year ago. In recent weeks, conservative groups had urged the Justice Department to appeal the judge’s ruling so that the contraception would not be available to very young girls. On Wednesday, a Justice Department official said the appeal would concentrate on the two areas where the department believes the judge overstepped his legal authority. The official also said the White House had not been involved in the decision of whether to appeal Judge Korman’s ruling.Reproductive rights advocates have criticized the administration’s position on emergency contraception as overtly political and having little to do with science or women’s health.“Age barriers to emergency contraception are not supported by science, and they should be eliminated,” Cecile Richards, the president of Planned Parenthood Federation of America, said in a statement on Wednesday.Continue Reading… … Read More
Justice Department appeals morning-after pill ruling
The US Department of Justice appealed a federal judge’s ruling ordering regulators to provide emergency contraception to women and girls of all ages. Wednesday’s appeal came just one day after the Food and Drug Administration allowed a manufacturer to make the Plan B One-Step…
FDA expands Plan B over-the-counter access to those 15 and up
The U.S. Food and Drug Administration announced on Tuesday that Plan B one-step emergency contraception will now be available to women ages 15 and up without a prescription. According the FDA website, the company Teva Women’s Health, Inc.’s application to market Plan B One-Step for…
Obama’s half-dose of Plan B
It sounded like a major victory for reproductive health: Per an announcement by the FDA late Tuesday, emergency contraception will finally be available on the shelves for anyone 15 and up. Until now, women under 17 have needed a prescription for the time-sensitive and safe medication, and anyone seeking to buy Plan B had to find an open pharmacy counter. This is unquestionably a move in the right direction.But there’s a catch. Less than a month ago, the Obama administration was court-ordered to lift the age requirement entirely, by a federal judge calling them out for politicizing the process. There’s no scientific or public health basis for any age limit — the idea is that the morning-after pill be sold just as condoms are — and requiring documentary proof of age presents a hurdle particularly for younger women and the undocumented. Also for no clear reason, Plan B will only be sold in places that have a pharmacy, as opposed to any convenience store, despite the fact that pharmacy employees will no longer be involved except for girls under 15.Continue Reading… … Read More
Obama, Plan B, Fear of Promiscuity, Sex and the Single Teen
In 2011, the U.S. Food and Drug Administration
ruled on the basis of scientfic evidence that Plan B emergency
contraception was safe and effective enough to be made available
without a prescription to all females who might want to use it. In
December, 2011 FDA Administrator Margaret Hamburg noted:
The Center for Drug Evaluation and Research (CDER) completed its
review of the Plan B One-Step application and laid out its
scientific determination. CDER carefully considered whether younger
females were able to understand how to use Plan B One-Step.
;Based on the information submitted to the agency, CDER
determined that the product was safe and effective in adolescent
females, that adolescent females understood the product was not for
routine use, and that the product would not protect them against
sexually transmitted diseases. Additionally, the data supported a
finding that adolescent females could use Plan B One-Step properly
without the intervention of a healthcare provider.
It is our responsibility at FDA to approve drugs that are safe
and effective for their intended use based on the scientific
evidence. ; The review process used by CDER to analyze the data
applied a risk/benefit assessment consistent with its standard drug
review process. ; Our decision-making reflects a body of
scientific findings, input from external scientific advisory
committees, and data contained in the application that included
studies designed specifically to address the regulatory standards
for nonprescription drugs. ; CDER experts, including
obstetrician/gynecologists and pediatricians, reviewed the totality
of the data and agreed that it met the regulatory standard for a
nonprescription drug and that Plan B One-Step should be approved
for all females of child-bearing potential.
In a transparently political move, the Obama administration’s
Health and Human Services Department issued an order
overruling the FDA and maintaining the requirement that the
contraceptive be available to females 16 years of age and younger
only by prescription. In his first inaurgural address, President
Obama
promised, “We will restore science to its rightful place.”
Evidently its “rightful place” was determined chiefly by how it
might affect his re-election chances.
Last week, a federal court judge
overruled the Obama adminstration and ordered that Plan B be
made available without prescription to all females who choose to
use it.
Why would anyone oppose making this safe and effective means of
contraception available? Some pro-life folks argue that Plan B is
an abortifacient, but the vast majority of researchers believe that
it works by interfering with
ovulation. Why else oppose? Fear of promiscuity. From the
New York Times today:
Dr. Mary Davenport, recent president of the American Association
of Pro-Life Obstetricians and Gynecologists, acknowledged that her
group’s opposition to Plan B is rooted in broader concerns about
casual sexual activity, teenage
pregnancy and single motherhood.
“Fear of pregnancy is a deterrent to sexual activity,” Dr.
Davenport said. “When you introduce something like this, it changes
people’s behaviors, and they have more risky sex. Teens will be
counting on this morning-after pill to bail them out, and they’ll
have more casual encounters.”
Bottom line: Let’s make pregnant teens and their children a
horrible warning to others! That’ll teach them! … Read More
Judge Orders the HHS to Relent on Emergency Contraception
There’s very little doubt, I suspect, in the minds of anyone that Kathleen Sebelius’s choice, which was vigorously defended by President Obama (and suspected to come from him), to overrule the FDA’s decision to make Plan B emergency contraception available over-the-counter without…
Judge orders ‘plan B’ contraceptive pill to be available for women of all ages
Currently, teens under the age of 17 can only obtain the emergency contraceptive pill with a doctor’s visit and a prescription. While older women do not need a prescription, the pill still remains behind the counter and obtainable only through showing a government-issued ID and placing an order.If the Food and Drug Administration (FDA) takes US District Judge Edward Korman’s ruling into account, teens could soon purchase the contraception without needing to go to their parents and requesting a doctor’s visit – an intimidating step that sometimes prevents sexually active girls from seeking out contraception. Reproductive rights groups have long advocated to make the morning-after pill more available to everyone, particularly teens. The Center for Reproductive Rights has repeatedly petitioned the FDA to make the contraception more accessible, only to be shut down by the US Department of Health and Human Services.The group had filed a long-outstanding lawsuit against the agency, whose secretary, Kathleen Sebelius, in 2011 overruled an FDA recommendation that the pill should be available without a prescription for everyone. In response to the lawsuit, Korman said the FDA’s rejection to remove the age restrictions to obtain the pill was “arbitrary, capricious and unreasonable.” His order represents a major victory for the Center of Reproductive Rights, which has been advocating the looser restrictions for years.“Today science has finally prevailed over politics,” Nancy Northup, president and CEO of the group, said in a press release. “This landmark court decision has struck a huge blow to the deep-seated discrimination that has for too long denied women access to a full range of safe and effective birth control methods.”If the FDA removes the age barrier, teens may be able to acquire emergency contraception in just a few weeks. Korman ordered the FDA to lift the restrictions on the sale of Plan B One-Step and its generic versions within 30 days.“More than 12 years have passed since the citizen petition was filed and 8 years since this lawsuit commenced. The FDA has engaged in intolerable delays in processing the petition. Indeed, it could accurately be described as an administrative agency filibuster,” he wrote.“The plaintiffs should not be forced to endure, nor should the agency’s misconduct be rewarded by, an exercise that permits the FDA to engage in further delay and obstruction,” the judge added.The FDA and the Department of Health and Human Services have so far declined to comment to the media, but some doctors have expressed their concern about a move that they believe sends the wrong message to young girls about pregnancy prevention.“Overall, it shows a lack of caution, if you ask me,” Dr. Jennifer Landa, chief medical officer for BodyLogicMD, told Fox News. “Of course the prevention of unwanted pregnancy is a good thing. The problem is [the morning-after pill] encourages women to be more cavalier and not use more reliable birth control we’d like them to be using, including barrier methods that protect against sexually transmitted diseases.”The physician also argued that the availability of the morning-after pill may convince uneducated women to bypass other birth control methods and opt for emergency contraception instead.“There are side effects with every medication,” Dr. Lisa Perriera of the UH Case Medical Center told Fox.“The amount of progestin in Plan B One Step is 1.5 milligrams of levonorgestrel, which is much higher than the amount of progestin in birth control pills – which have already shown to have side effects,” she added. “And higher doses of progestin would of course have higher side effects.”But other doctors argue that women and girls fearing pregnancy should have quick access to emergency contraception, and that any sort of delays brought on by doctor’s visits could be harmful in the long run.The Centers for Disease Control and Prevention found that in 2011, a total of 329,797 babies were born to women aged 15-19 years. In 2008, teen pregnancy and childbirth accounted for $11 billion per year for increased health care and foster care, higher incarceration rates among children of teen parents, and lost tax revenue due to lower educational attainment and low-income teen mothers. The costs are paid for by US taxpayers, which makes the prevention of unwanted pregnancies important, the CDC reports.It is not yet clear how the FDA will respond to Judge Korman’s ruling, but reproductive rights activists are celebrating the decision as a landmark victory. … Read More
