Are Emergency Contraceptive Pills Too Taboo for the Social Media Market?
Posted by on June 24, 2013 - 2:52pm

Many women don’t have all the facts when unprotected sex occurs.  Emergency contraceptive methods represent evolving and scientifically viable options for many women, yet are not adequately marketed to the public.  Emergency Contraceptive Pills (EPCs) offer women a fast and private over-the-counter option to use after unprotected sex.  With the multitude of contraceptive agents on the market, EPCs would seemingly be added to the marketing of family planning initiatives.  Yet, surprisingly, EPCs are not marketed effectively, and many women who may wish to consider EPCs as a last-resort option do not have sufficient access to this information.

Elizabeth Westley and Tara Shochet investigate this informational gap in their article Social Marketing of Emergency Contraception: Are We Missing a Valuable Opportunity?  In their attempt to understand this dilemma, they conducted a survey of four social marketing organizations that focused on contraceptive products.  These four organizations were DKT International, Marie Stopes International, Population Services International, and ProSalud Inter Americana; Westley and Shochet identified sub-programs housed under these organizations to get a large enough sample size for their research.  After extensive correspondence, they found that of the 100 programs they documented that focused on family planning, only 33% of them had substantial emergency contraceptive programs.  With data showing that, since 2005, ECPs sales have increased by roughly 7 million, it is difficult to understand why organizations are failing to develop EC programs when there is a clear consumer demand.

Policy barriers, funding difficulties, and lack of knowledge about emergency contraceptives contribute to the underdeveloped nature of EC initiatives.  Court rulings impact the accessibility and sales of emergency contraceptives, and political and non-political groups alike often campaign with anti-EC messages, deeming the issue too “politically sensitive” for many family planning organizations.  Funding and lack of knowledge or awareness about EC go hand-in-hand, since donors typically prefer supporting what is familiar and non-controversial.  Despite these barriers, emergency contraceptives must be effectively marketed to educate the majority of women in developing countries who are unaware of emergency contraceptives.  Furthermore, providing useful and accurate information to women about all their contraceptive options allow women, globally, the right to choose their contraceptive method from a range of alternatives.

The Truth About Emergency Contraceptives
Posted by on March 28, 2013 - 10:43am

Recently, emergency contraceptives have been at the center of the debate as to whether employers must cover contraception under their health insurance plans. Under the Affordable Care Act, which covers preventive care, non-exempt employers must cover the morning-after pill (Plan B) and the week-after pill (ella) for their employees. Some companies don’t want to follow this requirement because they claim that these drugs cause abortions. However, it seems that these claims are based on outdated information, because recent research now definitively proves that Plan B doesn't cause abortions, and that ella most likely doesn’t impact established pregnancies.

In the past, researchers knew that Plan B prevented pregnancy primarily by stopping ovulation, and therefore, fertilization. However, they were not certain whether it prevented fertilized eggs from implanting in the uterus. An abortifacient (abortion-causing drug) is something that interrupts an established pregnancy, which is typically considered to be when a fertilized egg implants in a woman’s uterus. By this definition, a drug that causes an unimplanted fertilized egg to leave a woman’s body is not considered an abortion, but it is still objectionable by some parties.

Recent studies, including one led by the International Federation of Gynecology and Obstetrics, have proven that these objections are unfounded by showing that Plan B only prevents ovulation and fertilization. It in no way stops a fertilized egg from implanting in a woman’s uterus, and does not cause abortions. This is also most likely the case with the week-after pill, known as ella, although the research is not as definitive. Ella is related to the abortion drug, RU-486 (Mifeprex), but unlike that drug which predominantly affects a woman’s endometrium, ella more strongly affects a woman’s ovaries, preventing ovulation. One study found that the rate of women who took ella after ovulation experienced pregnancy at the same rate as women who did not take it, indicating that the drug most likely does not prevent implantation.

While there is still stronger controversy when it comes to ella, individuals in the medical field opposed to abortion are starting to accept the fact that Plan B doesn't cause abortions, which is an important step in its increased acceptance as a contraceptive.

Source: Rovner, Julie. “Morning-After Pills Don’t Cause Abortion, Studies Say.” NPR. 4 February 2013.

For more information on the preventive services covered for women under the Affordable Care Act, click here.

FDA allows vending machine with emergency contraception on campus
Posted by on February 9, 2013 - 12:44pm

FDA regulators announced they will not take action regarding a vending machine that dispenses emergency contraception on Shippensburg University's campus in Pennsylvania, MSN News reports.

The machine is located in the school's health center, which can only be accessed by students and employees, and offers Plan B One-Step for $25. Under federal law, individuals ages 17 and older may purchase EC without a prescription.

The machine has been in place for about three years but it wasn’t widely known until it drew national media attention last year, prompting critics to claim it would encourage students to have sex. In response to the scrutiny, the Student Senate and the University Forum both passed resolutions in support of keeping the machine.

Erica Jefferson, an FDA spokesperson, in a statement said the agency "looked at publicly available information about Shippensburg's vending program and spoke with university and campus health officials and decided not to take any regulatory actions."

Peter Gigliotti, executive director for university communications and marketing, in a statement said an additional card reader has been installed on the machine, which students must use before accessing the drugs (Eng, MSN News, 1/29).

Is it time for easier access to contraception?
Posted by on December 10, 2012 - 2:22pm

Several health experts are proposing to make the birth control pill available in the U.S.  without a prescription (as they are in many parts of the world). The American College of Obstetricians and Gynecologists (ACOG)  released a statement calling for oral contraceptives to be sold over-the-counter, no longer requiring a doctor’s prescription.

ACOG considered a host of issues, including the safety of birth control pills; whether pharmacists should have a screening role (which could raise the moral objection issue) ; adherence to taking the pill; whether women would skip other preventive care if they didn’t visit a health care provider for a prescription; and cost.

ACOG addresses frequent objections to OTC oral contraceptives by concluding that “several studies have shown that women can self-screen for contraindications,” and “cervical cancer screening or sexually transmitted infection (STI) screening is not required for initiating OC use and should not be used as barriers to access.”

ACOG recognizes  making the pill non-prescription might increase the cost for women who have health insurance which would only pay for prescribed drugs, and would have to pay out-of-pocket for the over-the-counter version.

The National Latina Institute for Reproductive Health issued this response to that concern:    The recommendation that birth control be available over-the-counter supports what we know about Latinas and contraception: over-the-counter access will greatly reduce the systemic barriers, like poverty, immigration status and language, that currently prevent Latinas from regularly accessing birth control and results in higher rates of unintended pregnancy.

Pre-Prescribing Emergency Contraception to Teens
On a similar issue, the American Academy of Pediatrics(APP), issued a statement recognizing high teen birth rates in the United States and barriers to access to emergency contraception for adolescents 17  and younger. The AAP strongly admonishes pediatricians who refuse to discuss or provide contraception to teens based on their own beliefs, stating:

  • Pediatricians have a duty to inform their patients about relevant, legally available treatment options to which they object and have a moral obligation to refer patients to other physicians who will provide and educate about those services. Failure to inform/educate about availability and access to emergency-contraception services violates this duty to their adolescent and young adult patients.
  • The AAP recommends that physicians provide prescriptions to emergency contraception like Plan B in advance, so teens have it ready if and when the need arises. They also urge physicians to provide accurate information to teens on this topic, and, “At the policy level, pediatricians should advocate for increased nonprescription access to emergency contraception for teenagers regardless of age and for insurance coverage of emergency contraception to reduce cost barriers.”

HHS Urged to Remove Restrictions on Emergency Contraception
Finally, a petition is circulating urging the U.S. Department of Health and Human Services to remove restrictions on emergency contraception and make it available to women of all ages without a prescription.

SOURCE:  Our Bodies, Our Selves

Breaking News: FDA ruling on emergency contraception overruled
Posted by on December 7, 2011 - 3:00pm

U.S. Department of Health and Human Services (HHS) Secretary Kathleen Sebelius today overruled federal drug regulators to block wider access to the emergency contraceptive known as Plan B.
A panel of scientists at the Food and Drug Administration (FDA) determined that Plan B should be made available without a prescription to women of all ages, according to a statement from FDA Commissioner Margaret Hamburg. Hamburg agreed with their decision, but Sebelius intervened to block over-the-counter access.

Many women's professional health organizations have advocated  that drugs for reproductive purposes should not be treated differently than drugs for other medical purposes and many are concerned that politics played a role in this case.   Congressional Republicans have been vocal about their opposition to expanding access to emergency contraception.  This action by Dr. Sibelius raised concerns that scientific experts charged with making access determinations about this drug have been stripped of their ability to make that decision.  If you wish to express yourself on  this current action, you can call  202-401-5781 or 202-205-5445.

The statements by FDA Commissioner and the Secretary of Health and Human Services are provided below for your review:

Statement from FDA Commissioner Margaret Hamburg, M.D. on Plan B One-Step

The U.S. Food and Drug Administration (FDA) has been carefully evaluating for over a decade whether emergency contraceptives containing levonorgestrel, such as Plan B One-Step, are safe and effective for nonprescription use to reduce the chance of pregnancy after unprotected sexual intercourse.

Plan B One-Step is a single-dose pill (1.5 mg levonorgestrel tablet) which is effective in decreasing the chance of pregnancy if taken within 3 days after unprotected sexual intercourse.  The product contains higher levels of a hormone found in some types of daily use oral hormonal contraceptive pills and works in a similar way to birth control pills.

Plan B One-Step was originally approved in July 2009 for use without a prescription for females age 17 and older and as a prescription-only option for females younger than age 17.  In February 2011, Teva Women’s Health Inc. submitted a supplemental application seeking to remove the prescription-only status for females younger than age 17 and to make Plan B One-Step nonprescription for all females of child-bearing potential.

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.

I reviewed and thoughtfully considered the data, clinical information, and analysis provided by CDER, and I agree with the Center that there is adequate and reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential.

However, this morning I received a memorandum from the Secretary of Health and Human Services invoking her authority under the Federal Food, Drug, and Cosmetic Act to execute its provisions and stating that she does not agree with the Agency’s decision to allow the marketing of Plan B One-Step nonprescription for all females of child-bearing potential.   Because of her disagreement with FDA’s determination, the Secretary has directed me to issue a complete response letter, which means that the supplement for nonprescription use in females under the age of 17 is not approved.  Following Secretary Sebelius’s direction, FDA sent the complete response letter to Teva today.  Plan B One-Step will remain on the market and will remain available for all ages, but a prescription will continue to be required for females under the age of 17.

A Statement by U.S. Department of Health and Human Services Secretary Kathleen Sebelius

Plan B One-Step is an emergency contraceptive, sometimes referred to as the “morning after pill.” Plan B One-Step is currently labeled over the counter to women ages 17 years and older, but is sold behind the pharmacy counter. It is available by prescription only to women 16 years and younger. My decision does not change any current availability of the drug for all women.

In February 2011, Teva Women’s Health Inc. submitted to the FDA a supplemental new drug application for Plan B One-Step. This application sought to make Plan B One-Step available over the counter for all girls of reproductive age. The science has confirmed the drug to be safe and effective with appropriate use. However, the switch from prescription to over the counter for this product requires that we have enough evidence to show that those who use this medicine can understand the label and use the product appropriately. I do not believe that Teva’s application met that standard. The label comprehension and actual use studies did not contain data for all ages for which this product would be available for use.

FDA has recommended approval of this application in its Summary Review for Regulatory Action on Plan B One-Step. After careful consideration of the FDA Summary Review, I have concluded that the data, submitted by Teva, do not conclusively establish that Plan B One-Step should be made available over the counter for all girls of reproductive age.

The average age of the onset of menstruation for girls in the United States is 12.4 years. However, about ten percent of girls are physically capable of bearing children by 11.1 years of age. It is common knowledge that there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age. If the application were approved, the product would be available, without prescription, for all girls of reproductive age.

The Secretary of the Department of Health and Human Services is responsible, acting through the FDA Commissioner, for executing the Federal Food, Drug, and Cosmetic Act. Today’s action reflects my conclusion that the data provided as part of the actual use study and the label comprehension study are not sufficient to support making Plan B One-Step available to all girls 16 and younger, without talking to a health care professional. Plan B One-Step will still be available over the counter to women ages 17 and older.

Because I do not believe enough data were presented to support the application to make Plan B One-Step available over the counter for all girls of reproductive age, I have directed FDA to issue a complete response letter denying the supplemental new drug application (SNDA) by Teva Women’s Health, Inc..