State Rep. Charlene Fite was the lead sponsor of legislation called, "The Abortion-Inducing Drugs Safety Act." This misleading Act alsowas supported by all the other area legislators and signed into law by Gov. AsaHutchinson.
The stated purpose of the Act is to "Protect women from the dangerous and potentially deadly off-label use of abortion inducing drugs…" and "Ensure that physicians abide by the protocol tested and approved by the United States Food and Drug Administration for such abortion-inducing drugs, as outlined in the drug labels."
A physician who prescribes these drugs to patients without following the FDA protocol or who fails to follow the reporting procedures outlined in the Act are subject to the penalties of a Class A misdemeanor. This would allow for a prison sentence of up to a year and a fine of up to $2,500. The act also allows for civil suits and professional disciplinary action against the physician.
The act explains the protocol approved by the FDA, which is referred to as the "Mifeprex regimen."
As approved by the United States Food and Drug Administration and as outlined in the final printed labeling of mifepristone, an abortion by mifepristone consists of three 200 mg tablets of mifepristone taken orally, followed by two 200 mcg tablets of misoprostol taken orally, through 49 days from the first day of the woman’s last menstrual period.
This treatment requires three office visits by the patient, and the dosages may only be administered in a clinic, medical office, or hospital and under supervision of a physician.
The act asserts that physicians are routinely failing to follow this protocol and that the consequences "may be deadly" for their patients. The changed dosage is described in the Act: "providers are administering a single oral dose of 200 mg of mifepristone, followed by a single vaginal or buccal dose of eight-tenths mg misoprostol, through 63 days of the woman’s last menstrual period, without medical supervision and without follow-up care."
It looks like Rep. Fite is trying to protect her constituents from some very bad physicians but under closer scrutiny that may not be the case. The Abortion-Inducing Drugs Safety Act is not legislation drawn up by Arkansas legislators to protect their constituents. It is model legislation drafted by Americans United for Life (AUL) which comes with a Drafter’s Note to state representatives: "AUL has drafted detailed talking points to assist those interested in introducing this model in preparing for and countering arguments typically used by abortion providers. These talking points are available upon request by contacting AUL’s Legislative Coordinator at (202) 289-1478 or Legislation at AUL.org." AUL claims to be "the nation’s premier pro-life legal team" that "works at the state level to craft tailored strategies and legislative tools that will assist state and local officials as they defend and protect life."
Do physicians really seek to harm their patients as this Act suggests or do doctors have good medical reasons for not following the FDA protocols on these drugs? To answer that question, it might be helpful to consider the Amicus Brief filed by the American College of Obstetricians and Gynecologists (ACOG) and the American Medical Association (AMA) in the Texas case of Planned Parenthood v. Abbott, which in part presented the same issue.
"The ACOG is a non-profit educational and professional organization founded in 1951. The college’s objectives are to foster improvements in all aspects of healthcare of women; to establish and maintain the highest standards for education; to publish evidence-based practice guidelines; to promote high ethical standards; and to encourage contributions to medical and scientific literature. The college’s companion organization, the American Congress of Obstetricians and Gynecologists, is a professional organization dedicated to the advancement of women’s health and the professional interests of its members. Sharing more than 57,000 members, the college and the congress are the leading professional associations of physicians who specialize in the healthcare of women…"
"AMA is the largest professional association of physicians, residents and medical students in the United States…The objectives of the AMA are to promote the science and art of medicine and the betterment of public health…"
"The practice of medicine should be based on the latest scientific research and medical advances. Absent a substantial public health justification, legislatures should not interfere with patient care, medical decisions, and patient-physician relationship. Laws that mandate a medical abortion protocol that goes against best medical practice guidelines are dangerous to patient health. Even laws that mandate a protocol that is valid at the time of the law’s enactment are ill-advised because medical knowledge is not static. As knowledge advances medical treatments enshrined within such laws become outdated, denying patients the best evidence-based care.
As a result of three decades of studies of various medical abortion regimens, a number of evidenced-based regimens have emerged that make medical abortion, safer, faster, and less expensive, and that result in fewer complications as compared to the protocol approved by the FDA over 13 years ago … regimens using 200mg of mifepristone orally and 800ug of misoprostol vaginally were associated with better outcomes, fewer side effects, and lower costs for women with pregnancies up to 63 days of gestation. Practice Bulletin No. 67 concluded that a patient could administer misoprostol safely and effectively, orally or vaginally, in her home, eliminating the need for an additional visit to a health center and allowing the patient greater control over the time and place of her abortion …"
"The FDA allows ‘off-label’ use of registered products—meaning use that is not expressly provided for in an FDA-approved label—when existing medical evidence supports such use. Accordingly, prescribing medication off-label is common in every field of medicine, and in a large number of fields most patients are prescribed at least one drug off-label…"
"Research in medical care is always continuing; for medical abortion, continued research demonstrates advances every year, with the development of newer, evidence-based regimens that make medical abortion safer, faster, less expensive, and result in fewer side effects, and that are superior to the FDA-approved regimen. In fact, evidence-based regimens through at least 63 days of gestation are safer and more effective than the FDA-approved regimen up to 49 days of gestation. As with any medical care, treatments that are safer and more effective are medically preferable…"
Legislation that is a "restriction on the regimens that can be used for medical abortions is especially harmful to those women with certain medical conditions that make first-trimester medical abortions (even after 49 gestational days) recommended over other abortion methods, such as aspiration. Those conditions include certain uterine anomalies and a stenotic (narrow) cervix."
It all boils down to who has the patient’s best interest at heart? Is it more likely to be the patient’s doctor or a group of legislators with an anti-abortion agenda? The motivations of Rep. Fite and her legislative allies are obvious. They will attempt to limit abortion by any means available, including subterfuge. Under the guise of protecting women, they are in fact endangering the lives of women by denying them the best medical treatments available.