U.S. Supreme Court to review mandate to insure contraception
Posted by on November 26, 2013 - 12:33pm

The Supreme Court on Tuesday, November 26,  agreed to hear cases on whether corporations may refuse to provide insurance coverage for contraception to their workers based on the religious beliefs of the corporations’ owners.   President Obama’s health care law has exempted many religious groups from the law but did not exempt for-profit corporations because of owners' religious objections.

The National Women’s Law Center (NWLC) will be submitting a “friend of the court” brief to the Supreme Court that lays out how birth control advances the health and rights of women. Nearly 99 percent of women use contraception at some point during their reproductive years who come from a variety of religious faiths.  And currently nearly 27 million women can get free birth control without copays — a number that will increase as the health care law continues to go into effect.

Most women's organizations believe that allowing bosses to make women’s health care decisions is a dangerous precedent that could lead to companies refusing to abide by other laws that protect their employees, such as employment protections like minimum wage or equal pay. 
Sign the pledge to say all women deserve to make their own birth control decisions — no matter where they work.

 

 

 

In the Debate on Women's Reproductive Rights, Where are the Women?
Posted by on June 19, 2013 - 2:53pm

The pro-life v. pro-choice debate continued on the House floor yesterday as party representatives grappled with sustaining women’s reproductive rights in a surfacing abortion bill.  On Tuesday, the House of Representatives approved a bill banning a woman’s right to pursue an abortion after 22 weeks of pregnancy, subtracting two weeks off the current cut-off of abortions at 24 weeks in utero.  The majority-Republican party passed this bill shaving off the extra two weeks based off the medically disputed theory that a fetus is capable of feeling pain 20 weeks after conception (which is equivalent to 22 weeks of pregnancy).  Democrats in the House and the White House fought against the bill, saying the legislation is an “assault on a woman’s right to choose” and is an attempt to undermine the precedent set in the 1973 Roe v. Wade trial.

The argument quickly split down party lines (only six party members from each side voting against their party) and escalated into a debate on women’s reproductive rights.  In this heated bipartisan debate, representatives from both sides evoked emotional appeals.  Though different in message, consistent across both lines is the lack of the female voice.  While the House attempted to integrate more women in this debate, only 19 of the 222 Republican House members who voted for this bill are women.  In total, the House of Representatives only has 78 women, accounting for a meager 18% voice in the House.  Furthermore, there are no Republican women on the Judiciary Committee panel that has jurisdiction over this particular legislation.

While this bill certainly made headlines, the threat of it obtaining further approval is low.  Sources agree that the bill will not find support in the Democrat-controlled Senate, and President Obama has also already voiced his opposition.  Although no abortion laws are changing today, it is important to keep abreast on the dialogue surrounding this controversial and emotional topic.  Most importantly, government representatives must do a better job of allowing women’s voices and opinions to be heard.  Female reproductive rights issues have been considered taboo for too long, and an open dialogue in the government may help bridge the gap between women and policy.

Sources: ABC News, USA Today, and The New York Times.

 

The Morning After: Women, the Vote, and Reproductive Health
Posted by on November 8, 2012 - 9:24am

Yesterday morning we awoke to a political landscape that seems jarred by the process of democracy, but ready to move forward as a nation.  Three issues defined the outcome:  the percent of women who chose democratic principles; the resounding losses by candidates who are antiquated in their thinking about pregnancy, in particular; and, the need to hold all of us accountable as citizens in the care of each other starting at the research bench to the bedside.   I’m a reproductive scientist and direct the Women’s Health Research Institute at Northwestern University, so these issues are my issues and it is now time to look forward and identify actionable steps that moves our field forward.

I’ll start with the women.  I believe the 55% to 43% differential in the women’s vote for Obama was not just a vote for a person, but for a platform.  It is a vote that recognizes that sexuality is not something that can be regulated by the state.  It is a vote that states emphatically that the fact of rape is never legitimate. It says that the consequences of forced intercourse are never ‘god’s will’.  Women ‘got’ the vote in 1920 and today their votes say that the politicians must begin to understand that women’s concerns are important and legitimate.

How we move forward to ensure that women’s bodies and their health are not political footballs or pincushions (depending on your gender-identified metaphor) is critical.  Here are some suggestions:

  • We can no longer allow basic research and new drug development be done solely in male models (cell, animal or human) —this practice loses the ‘bang for our buck’ when we discover sex differences further down the research pipeline.
  • We must report sex differences (or no difference) in study findings and include them in our scientific publications.
  • We must redistribute more federal dollars to fund important reproductive health studies that include the ovary, uterus, testis, egg, and sperm that impact the next generation of Americans.  (The Reproductive Science Branch of the National Institute of Child Health allocates only .022% of $30 billion to address reproductive health issues)
  • And we must invest in tomorrow’s generation of innovators who might now be high school students or graduate students by funding innovative education programs and traditional training grants today that include a respect for sex and gender differences in all aspects of health and well-being.

I’ve gone from the very broadest issue of our day – the election and women’s issues and women’s votes – to the very granular issues of funding the next generation of research.  Bill O’Reilly, speaking on Fox News election night said that 50% of the population voted for Obama because they want ‘stuff’.  I think the ‘stuff’ we want is the right to speak our mind and be heard on issues that concern our health and the health of our families. We want  our bodies to be respected by politicians, scientists, and everyone in between.  The ‘stuff’ we want is assurances that the biomedical community is including male and female animals and patients in all of the scientific studies that we, women, fund through our taxes.  The ‘stuff’ we want is to make sure that there is a way forward for research in an area that without question, touches each and every one of us.  Our vote suggests that that ‘stuff’ is important and on this ‘morning after’ we are looking forward to the next four years.

Author:  Teresa K. Woodruff, PhD, Thomas J. Watkins Professor of Obstetrics and Gynecology

Cost of Contraception
Posted by on February 24, 2012 - 11:00am

As predicted, the debate about access to contraception in the U.S.  has entered the political process with the counter attack focusing on freedom of religion.  This blog will look at another side of the issue:   cost.   The cost of contraception is estimated to be between $600 and $1000 per year based on the choice of contraceptive method.   According to a report issue by the assistant secretary for planning and evaluation at the US Department of Health and Human Services, "evidence from well-documented prior expansions of contraceptive coverage indicates that the cost to issurers of including coverage for all FDA-approved contraceptive methods in insurance offered to an employed population is ZERO."

After a review of actuarial studies, one of the study authors concluded that "....regardless of payment mechanism or contraceptive method, contraception saves money".   When indirect costs are considered, (time away from work, productivity loss, etc.) contraceptive benefits actually save an employer money.

The report found that providing contraception through public programs is also cost-saving.   Public funds for family planning prevents about 1.94 million unintended pregnancies, including almost 400,000 teen pregnancies according to the report.    When some people say contraception is an important health issue, they are right.  Consider this,  preventing 1.94 pregnancies results in 860,000 fewer unintended births, 810,000 fewer abortions and 270,000 fewer miscarriages.   Avoiding significant costs associated with these unintended births saves taxpayers $4 for every $1 spent on family planning.To read the full report summary and references, click HERE.

Not only is contraception access an important women's health issue because it is used to treat several conditions beyond preventing pregnancies, it is much more cost effective than programs like abstinence only and those that support women who remain in poverty due to unintended pregnancy.  It is interesting to note that the majority of proponents of the religious freedom point of view are men!  Wonder if they would feel so strongly if they were the ones to get pregnant!

 

 

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..