The draft regulation (PDF) goes into detail outlining the history of the laws protecting the conscience of health providers and entities and then outlines the problem. It seems that the central concern is not discrimination against those who won’t perform abortions, but that the US Department of Health and Human Services sees a real problem with requiring health professionals (and anyone in the healthcare workforce) to be involved with contraception, even if it is part of the job. The majority of the section outlining “The Problem” concerns states that have passed laws or issued executive orders requiring pharmacies to dispence contraception, including emergency contraception, and that require hospitals to provide emergency contracption to rape victims.
From the regulation:
In 2005, Illinois Governor Rod Blagojevich issued executive orders requiring “a retail pharmacy serving the general public [… to] dispense the contraceptive, or a suitable alternative permitted by the prescriber, to the patient or the patient’s agent without delay,” over the objection of pharmacist groups
In May 2007, Connecticut passed a law requiring all hospitals to distribute Plan B to rape victims, despite religious rganizations’ objections to the abortifacient nature of the drug.9
A New Jersey law requires pharmacies to fill prescriptions “despite any conflicts of employees to filling a prescription and dispensing a particular prescription drug or device due to sincerely held moral, philosophical or religious beliefs.”10Massachusetts11 and New Mexico12 have passed laws similar to the laws and executive orders in Connecticut, Illinois, and New Jersey.
These are problems? Serious enough to issue new enforceable regulations about infringing people’s conscience on abortion?
When the Administration overruled scientific staff at FDA and outside experts regarding bringing emergency contraception, it seemed clear to me that we were facing an attack on all contraception. Given that the vast majority of people in the United States support access to safe and effective contraception, and indeed the vast majority of people of reproductive potential have used or use contraception in some form, this is not a subject we should be arguing about at the federal level.
The fact that emergency contraception was so controversial that it took over 3 years and 3 FDA commissioners before it was even partially approved for those 18 and older told us that those opposed to contraception (although a small group of people) had disproportionate influence in this government. Despite the scientific and medical evidence, the administration still sees contraception as something to be blocked.
When Plan B was partially approved, the first thing to notice was that the sky did not fall. Adult women have access to another form of contraception, another option if regular contraception failed or if the woman was raped.
But clearly the war on contraception is not over. That same small group of highly influential people who want to limit access to contraception are back at work within HHS. They’ve now worked to broaden the definition of abortion to include contraception contrary to the definitions of the American Medical Association and the American College of Obstetricians and Gynecologists. In part they base it on a poll from 2001.
A 2001 Zogby International American Values poll revealed that 49% of Americans believe that human life begins at conception. Presumably many who hold this belief think that any action that destroys human life after conception is the termination of a pregnancy, and so would be included in their definition of the term “abortion."
This strikes me as an unfounded assumption. Most people do not think use of oral contraceptives, injectable contraceptives or an intrauterine device (IUD) are forms of abortion, even with full understanding of the possibility that sometimes the mechanism of action may involve reducing the likelihood of implantation of a fertilized egg. Most people understand that contraception acts prior to pregnancy (as defined by implantation in the uterus) and that abortion is termination of an established pregnancy.
The leaked draft regulation also broadens who is protected by this new regulation. Not just providers, but anyone involved in the process, from appointment schedulers to those who clean the instruments in a hospital, to the hospital itself all now can refuse to be involved with their job, with federal protection, if the facility or clinic provides contraception.
It’s a good sign that this document was released early by someone inside HHS, so that the public can get a head start in understanding what is coming next from the Administration, when it comes to limiting access to contraception. Another good sign for scientific integrity is information that not all of the scientific and health agencies within HHS agreed (”concurred”) with issuing this proposed regulation.
Whether or not such objections within HHS will block the release of this regulation, it is important that the scientists and medical experts within the Department raise their voices, and I congratulate those who have done so. There are consequences in research and development of new medical products and in infertility clinics if the definition of abortion reaches back to fertilization. The scientific and medical communities need to be heard on the impact of this change, along with the voices of women and couples who stand to lose access to safe and effection contraception.
]]>This article originally published on The Pump Handle.
I have been working to improve health care for women and families in America for nearly 20 years. In 2000, I became the Director of Women's Health for the FDA. I was rather quietly doing my job when the debate began in 2003 over whether or not emergency contraception should be providedover-the-counter (OTC). As a scientist, I knew the facts showed that this medication, which can be used after a rape or other emergency situations, prevents an unwanted pregnancy. It does not cause an abortion, but can help prevent the need for one. But it only works if used within 72 hours and sooner is even better. Since it is completely safe, and many women find it impossible to get a doctor's appointment within two to three days, making emergency contraception available to women without a prescription was simply the right thing to do. As an FDA employee, I knew it should have been a routine approval within the agency.
Plan B emergency contraception is just like birth control pills - it is not the "abortion pill," RU-486, and most people in the United States don't think access to safe and effective contraception is controversial. Sadly, in Congress and in the White House, there are many people who do oppose birth control. And although this may surprise you, this false "controversy" not only has affected emergency contraception, but also caused the recent dramatic increase in the cost of birth control pills on college campuses, and limited family planning services across the country. The reality is that having more options for contraception helps each of us make our own decisions in planning our families and preventing unwanted pregnancies. This is something we can all agree on.
Meanwhile, inside the walls of the FDA in 2003-2004, the Bush administration continued to throw road blocks at efforts to approve emergency contraception over the counter. When this struggle became public, I was struck by the leadership that Hillary Clinton displayed. She used the tools of a US Senator and fought ardently to preserve the FDA's independent scientific decision making authority. Many other senators and congressmen agreed, but she was the one who took the lead, saying she simply wanted the FDA to be able to make decisions based on its public health mission and on the medical evidence.
When it became clear that FDA scientists would continue to be overruled for non-scientific reasons, I resigned in protest in late 2005. I was interviewed by news media for months and traveled around the country hoping that many would stand up and demand that FDA do its job properly. But, although it can help, all the media in the world can't make Congress or a President do the right thing.
Senator Clinton made the difference. The FDA suddenly announced it would approve emergency contraception for use without a prescription for women 18 and older - one day before FDA officials were to face a determined Senator Clinton and her colleague Senator Murray at a Senate hearing in 2006. No one was more surprised than I was. I hope all of those who benefited fromthis decision know that it wouldn't have happened if it had not been for Hillary Clinton.
Sometimes these success stories get lost in the "horse-race stories" about political campaigns and the exposes of taxpayer-funded bridges to nowhere, and who said what to whom. This story of emergency contraception at the FDA is just one story of many. Senator Clinton saw a problem that affected people's lives. She then stood up to the challenge, never wavered and worked to solve it. The challenges we face in health care, our economy, global climate change, and issues of war and peace, need a leader who has those skills and commitment. This is my view.
]]>Looking back on the last two years and considering what has happened over the last year in particular – after emergency contraception got partial approval for sale without a prescription – I can draw a few lessons from my experience.
First, individual people working together can make a difference. All those people around the country who were outraged over the continued delay in permitting women access to a safe and effective contraceptive method managed to get their voices heard. The realization that those opposed to contraception somehow managed to thwart the scientists and physicians at FDA from doing their jobs was a surprise and a bit of a shock to folks from all walks of life. I think that this realization and the response of the public led to the ultimate approval (limited though it is) of emergency contraception OTC. We should remember this as we face continuing challenges in this arena and in others.
The second lesson I draw is not a surprising one to me. The sky didn’t fall, and women have begun to get access to one more option to help them prevent unwanted pregnancies. Timely access to emergency contraception should not have been and should not be a controversial subject. Those who have heard me on this subject know that this is a mantra for me. Even though people may keep their own contraceptive choices private, contraception is not a controversial subject. It doesn’t shock the vast majority of people in the United States to think that most couples have used and continue to use contraception. The details for any particular couple may be more information than most people want to know (that’s why it’s private), but access to contraception itself is widely supported and assumed. One more method available to women – and one that can provide a second chance – is a common good. It neither promotes promiscuity nor serves as a magic bullet in preventing all unintended or unwanted pregnancies, but it provides a woman with another form of prevention, should she need it.
Looking forward we have to continue to work to ensure that the health of the public remains our priority. There are still those who want to deny women access to contraception (emergency contraception or otherwise). Some of them are in the pharmacies, some of them are in hospital emergency rooms, some of them are in the government, but they are a small minority of the public and they shouldn’t be able to force their opinions either on women seeking contraception or on government agencies (like FDA) making health policy decisions. I think we can get there.
]]>