Mourning After
For many women, there are still roadblocks to Plan B.
By Emily Amick, Wellesley College
Tuesday September 26, 2006
Overwhelming scientific evidence is usually enough to demonstrate to the FDA the safety of a drug. Similarly, citizen response usually compels government branches to action.
 Such has not been the case for the Plan B emergency contraceptive, also known as the “morning after pill.” After years of trial and tribulation, on Aug. 24 the FDA finally granted Barr Pharmaceutical’s Plan B over-the-counter status. There are two caveats, however: The drug can only be purchased by people 18 and older, and in many states, Medicaid and private insurance do not cover Plan B.
Plan B’s new over-the-counter status will substantially increase the availability of emergency contraception for most women, and is a positive step toward increasing women’s access to birth control methods. And even with the age restriction, minors now have increased access to Plan B, because it will be legal for them to take the drug if it is purchased by anyone of legal age. Nonetheless, the 18 or older restriction is scientifically unsubstantiated, and the FDA’s decision negatively impacts the thousands of young women who unintentionally become pregnant every year, as well as low-income women of all ages.
The battle over Plan B over-the-counter access has centered for several years on the safety of the drug for teenagers. In May 2004, the FDA overturned a December 2003 decision by two FDA advisory committees to make Plan B available over-the-counter to all age groups. Despite evidence showing that teens as young as 15 would not increase “risky behavior” if they knew that emergency contraceptive was available, the acting director of the FDA’s Center for Drug Evaluation and Research, Dr. Steven Galson, claimed there was not adequate data showing exactly how adolescent women would use the drug. The FDA approved Plan B over-the-counter access for women over 18 on Aug. 24 of this year, rejecting Barr’s last-ditch effort to include 16 and 17-year olds.
“While we still feel that Plan B should be available to a broader age group without a prescription, we are pleased that FDA has determined that Plan B is safe and effective for use in those 18 years of age and older as an over-the-counter product,” Carol Cox, vice president of investor relations and corporate communications for Barr Pharmaceuticals, told Campus Progress.
Cox added that while “the company does intend to continue our efforts with the FDA to reduce the age restriction on the OTC use of Plan B,” Barr is “currently in discussions with the FDA as to what clinical data will be needed and once that is determined we can start developing a design of a trial or trials that would be necessary to collect such data.” Barr CEO Bruce Downey previously told The New York Times, "In my mind, if we go back and have an adequate study that includes the younger group, the basis for any age restriction goes away."
The Alan Guttmacher Institute reports that among women aged 15 to 17, there were 271,000 pregnancies in the U.S. in 2001. Eighty-seven percent of those pregnancies were unintended, equating to over 235,000 young women who might have been interested in having easier access to Plan B. But the only way for the age limitation to be changed is for either Barr or another pharmaceutical company (people are watching Gynetics, Inc. the makers of another form of emergency contraception, Preven) to resubmit an application for over-the-counter access without restrictions based on age. The new application would then be considered by the FDA. Emily Stewart, a Policy Analyst at Planned Parenthood Federation of America, told Campus Progress that the age limitation appears to be mostly about the Bush administration’s politics, not FDA policy.
The New York Times reported that Dr. Janet Woodcock, a deputy commissioner of the FDA, told Dr. Florence Houn, director of the office that evaluated the Plan B application, that a rejection was necessary "to appease the administration’s constituents, and then later this [Plan B] could be approved."
All along, the decision was more about political posturing than the health and well-being of young women. The Center for Reproductive Rights filed a lawsuit in January 2005 against the FDA for failing to grant Plan B over-the-counter status. Subpoenaed correspondence between the FDA and White House and admissions by FDA officials reveal that the Bush administration significantly influenced the Plan B application review process. Nancy Northup, President of the Center for Reproductive Rights said in a August 2006 press release, “Depositions in our lawsuit against the FDA continue to unearth a tangled web of deceit and obfuscation behind-the-scenes in which agency officials, acting under outside political influences, made a compromise to circumvent regulations, ignore its scientific experts, and delay any action on Plan B for as long as possible, then only grant limited access.” Dionne Scott, spokesperson for the Center for Reproductive Rights, told Campus Progress that, if successful, the Center’s lawsuit will result in a lifting of any age restrictions. This is perhaps the most feasible avenue for Plan B to become over-the-counter for all women, though not a short-term solution by any means.
In the meantime, Barr has indicated it will continue to pursue more scientific studies to prove the safety of over-the-counter access to Plan B for young people. But there have already been scientific studies showing this. A 2005 study in the journal Obstetrics & Gynecology showed that over-the-counter access to emergency contraception does not increase or encourage teen sexual activity. Other studies have shown that women do not use emergency contraception as a regular method of birth control.
“Emergency contraception has been proven safe for young women—the only thing holding back EC access for teen girls is the politically-motivated excuse that it will somehow make them promiscuous,” Jessica Valenti, executive editor of Feministing.com, told Campus Progress. “Not only is this ridiculous and untrue, it’s insulting. If a young woman wants to prevent getting pregnant, we should be doing all we can to help her, not make things more difficult.”
Since the age restriction is only at the point of purchase, women under 18 will be able to have a family or friend purchase the emergency contraceptive for them. There are already several underground Facebook groups of women over 18 who are willing to buy Plan B for high school students.
There are currently also nine states—Washington, California, New Mexico, Alaska, Hawaii, Maine , New Hampshire, Massachusetts, and Vermont—that allow women of all ages to buy emergency contraceptives from specially trained pharmacists with the authority to write prescriptions without a doctor’s input (the program is called collaborative practice; visit www.EC-Help.org to find a participating pharmacy in your area). These state programs are not threatened by the FDA decision. But w omen in other states are going to have to work around the restriction for now. There are no legal restrictions that prevent out of state individuals under 18 traveling to collaborative practice states and purchasing Plan B from a trained pharmacist. Planned Parenthood is also going to continue providing emergency contraception to young women through its local health centers (1-800-230-PLAN or www.not-2-late.com).
Plan B is currently sold for $25 to $40 per dose. Planned Parenthood offers sliding scale fees for emergency contraception; high school students can even get it for free. Barr has suggested that the price could change; The New York Times reported that the price will probably increase due to higher distribution and packaging costs. According to Barr, more than half of all buyers ask for insurance reimbursement when they receive Plan B—including people on Medicaid.
Mary Kahn, spokesman for Medicaid, told Campus Progress that Medicaid does not cover any over-the-counter drugs, and therefore will not be covering Plan B. States will have to use state funds to cover Plan B, and California and Minnesota have said they will cover it. Carol Cox of Barr Pharmaceuticals told Campus Progress, “In general, most OTC products are not covered by insurance. However, [Barr] is still exploring how the Plan B OTC product will be treated.”
Even if Medicaid will no longer cover Plan B, some low-income women will still be able to receive the drug significantly discounted at some community health clinics. David Bowman , a spokesman for the Health Resources and Services Administration told Campus Progress, “Federally-funded health centers that purchase Plan B under the 340B Drug Discount program may pass along the discount to patients of the health center.”
The realities of who will have immediate access to the drug are still unclear. If taken within 72 hours of unprotected intercourse, Plan B reduces the risk of pregnancy by 89 percent. The earlier EC is administered after unprotected sex, the more effective it is. Therefore, decreasing the number of hurdles between the buyer and the product is critical in order to allow more women to take advantage of the drug.
Barr’s time frame for reestablishing the scientific safety of Plan B for young women remains unclear. The legal suit against the FDA is probably the fastest route to expanding access. In the meantime, working to ensure that women who want the drug are able to afford it, creating awareness about the drug’s availability, and broadcasting accurate information on the drugs proper use will be primary concerns for health centers across the country.
Illustration: Matt Bors
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Comments
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Emily,
— Genna - Sep 29, 04:30 PM - #I thoroughly enjoyed your article and completely agree with you on the dire need to expand access to emergency contraception. Unfortunately the FDA is not the only obstacle facing Plan B. Another insidious threat lies in the individual pharmacists who refuse to sell Plan B to the women who desperately need it. Should pharmacists be legally obligated to provide EC even if it is against their moral principles? I don’t know the answer, but it seems unconscionable to me that a scared, distressed young woman would be denied the pill that would ensure her safety against an unwanted pregnancy.
Campus Regress, consider the following,
1.The Law of Biogenesis states that each living thing reproduces according to its own kind!
Dogs beget dogs, cats beget cats, frogs beget frogs, and humans beget………….humans!!!!
2.At conception, there are two “lumps of cells” that we call sperm and ovum, but the zygote, after conception is a distinct, unified, self-integrating human organism. All genetic material needed to drive the unborn’s development is there! That means that from this point on there is an individual human, and she or he will remain so! It is an immature human, as is an infant, but a human being nonetheless!
3.Look, the unborn may feel pain as early as 9 weeks, but certainly by 13 WEEKS, so what George Soros’s bought and paid for cronies at “Campus Regress” call a “Woman’s Right to Choose” is really a Woman’s Right to Choose to Torture her unborn baby to death!! Abortion doctors admit that the “fetus, in many cases, dies just as a human adult or child would: it bleeds to death as it is torn limb from limb…The “fetus” can be alive at the beginning of the dismemberment process and can survive for a time while its limbs are being torn off…Dr. Leroy Carhart has observed fetal heartbeat…with “extensive parts of the fetus removed”….and testifies that dismemberment does not always cause death because he knows of a physician who removed the arm of a “fetus” only to have the “fetus” go on to be born “as a living child with one arm.”….At the conclusion of a D&E abortion…the abortionist is left with a tray full of pieces.
http://www.mttu.com/abort-pics/How%20many%20more.jpg
I will concede to you about abortion Campus Regress on one condition, IF YOU CAN PROVE THAT THE UNBORN IS NOT HUMAN!!
But if you do not know, then consider this analogy: could you imagine a structural engineer who blew up an old building with out first making sure that no one was inside!! What a nut-case he would be, right!!
Viva La Conservative Revolucion!!!!
Ryan Sorba
— Ryan Sorba - Sep 29, 10:50 PM - #Genna –
— Emily - Sep 29, 11:35 PM - #That’s a great point. I question whether, with EC OTC, pharmacists will be in the position to deny women EC. EC will be placed behind the counter – but a pharmacist won’t be needed to get it out. Possibly there could be other hurdles such as stores deciding not to carry the drug, etc… Of course, women under 18 will still need a prescription – but access will be substantially increased.
-Emily
I think that it should be available but for only use by a rape victim or someone who is physically unable to handle child birth….Its not too much you can argue about the age requirements because 18 is the legal age. Its not like alcohol or something. Its basically early abortion or even less, simply birth control. Who could argue with that?
— Anthony Edwards - Oct 3, 11:51 AM - #Emergency Contraception is NOT abortion. In fact, if a woman is already pregant (meaning the fertilized egg has implanted) when she takes EC, the pregnancy is not affected. Do not confuse Plan B with RU-486. Do your research first, boys.
— AF - Oct 4, 02:27 PM - #It obviously does not matter if the fertilized egg is “implanted” or not. Does location establish personhood? If so, then I beg of you, tell me where it is safe to stand!
Personhood is obviously not objectively intertwined with location. But for a moment, I would like to stray from this, the central issue, and gaze out, beyond the mist, and up the inclined plane of vast futurity.
Several questions came to me just the other night while I was reading; they came over me with a weight and power that hitherto, I had not known.
In his collection of essays, entitled, The Future of Human Nature, Jurgen Habermas, von Deutschland, speaks of “bodies stuffed with prostheses to boost performance,” and “the intelligence of angels available on hard drives,” he describes these as “fantastical images.” “There is fusion,” he writes, “of the organically grown with the technologically made…”But where in Habermas’s “world disclosive semantic” lies the sanctity of humanity? When the time comes that we can use drugs, and ever-lesser abrasive forms of abortion, indeed, even pre-implantation genetic diagnosis, to choose gender, eye color, height, intelligence, -where will humanity have gone?
This allusion is inevitable and haunting, at some point, some rogue nation will achieve the ability to cookie-cuts its posterity into superiors, at that point the race will commence! The whole human “species” will be competing for the greatest of descendents, if for no other reason than to secure themselves against the rest. This may, in fact, lead us to the genetic engineer’s equivalent of a Hiroshima.
And we perceive of the trees differently when we cut them down and saw them into beams, and the stars lost their divinity as astronomy progressed. I’ll admit, some of these advances were positive, but for these positive advances, we paid a heavy price. What will happen, and what price will we have paid, when we come to view humanity as such -as we view the trees when we cut them into beams. In my view we will have gone too far! We will have paid to great a price!
At some point, if this “pro-choice” perspective has its way, it will mark the end of humanity, and those who live in this “triumphant,” not so distant era, will not be humans, in any definitive sense of the word, humanity will have been lost, these men and women will be mere artifacts. Indeed, we must not hold a pistol to head of humanity. Humanity must be preserved!— Ryan Sorba - Oct 6, 01:03 AM - #Ryan, the Journal of the AMA says that you’re full of it about fetal pain, and I’m going to go with the experts.
The implantation of a fertilized egg in the womb is the definition of “pregnancy.” To argue that implantation is meaningless is to epitomize self-delusion.
As to your tortured metaphysical definitions of “humanity,” you have to be willing to make the jump from what is potential to what is actualized for your rationale to hold water, and that’s one hell of a jump.
Here’s an idea—stop the gay bashing, the sci-fi alarmism and the pseudoscience. No matter how pious you wish to be, you’re coming across as a monumental jackass. Plugging your ears and wishing really, really hard for something you believe to come true just isn’t going to cut it, bucko.
— JR - Oct 9, 06:16 PM - #To Jr. -the Artifact.
Abstract Man, go to this website: http://jfaweb.org/index.html
(there is an even better one but I can’t remember it) and then tell me that abortion is not murder. If you are not mature enough to look, then you are not mature or authentic enough for me to even bother refuting.
Oh ya, and “gay” is a false word, you see it implies “constitutionality,”in regards to the post-modern identity, but there is no such thing. None. And no! Same-gender sexual conduct is not sanctioned by the Law of Nature, (the first priniples) -that are the primary colors of reason, irreducible, and the basis for all human knowledge, therefore, the behavior is “rebellion” as is abortion, and consequently immoral. You may believe yourself to be a God, and therefore “Beyong Good and Evil” but then, you would simply be living in “delusion” because you have no more power of inventing a whole new system of values then you do of imagining a new primary color, or, indeed, of creating a new sun, and a new sky for it to move in.
Ryan
Ryan
— Ryan Sorba - Oct 10, 01:30 AM - #