How the FDA Is Helping to Thwart the Anti-Abortion Movement
Think of a medication you take. Now imagine that state legislators passed a law saying any doctor prescribing that medication had to administer three times the necessary dose—just because that’s the way it was done in the 1990s.
That is exactly what has been happening with mifepristone, one of two medications used to induce therapeutic miscarriage, also known as medication abortion. The same meddling legislators have forced doctors to prescribe the other medication, misoprostol, at a lower than ideal dosage, increasing the risk of an incomplete miscarriage.
In recent years, religious right abortion foes have passed a wide range of bogus restrictions they claim are aimed at protecting women’s health. Actually, these rules (the subject of the new documentary, Trapped) are intended to reduce the availability of abortion care and many actually increase health and safety risks. In Texas, bogus health rules have driven most clinics out of business and have led over 100,000 women to explore or attempt some form of self-abortion.
One of the bizarre rules forces doctors to administer triple the amount of mifepristone necessary to induce an early miscarriage. This was accomplished by legislating that doctors had to prescribe the medication exactly as it was done in the mid-'90s when the drug first passed clinical trials and was labeled by the FDA. On top of that, some states passed laws forcing doctors to march each woman into an operating theater and watch her swallow the unnecessary pills.
How Prescribing Works
Medical care is constantly evolving and improving. After the FDA approves a medication, doctors refine prescribing practices over time as research shows that a drug can be used safely at lower or higher doses or under different circumstances. With mifepristone, one of two drugs used in medication abortion, the standard of care for the last 10 years has been that doctors prescribe 200 rather than 600 milligrams of the drug. Although excess mifepristone has few side effects other than malaise and nausea, the forced overdose drives up the cost of medication abortion by hundreds of dollars. For religious right legislators, that was the point.
Updated Label, Better Care
As of March 30, the FDA, via a standard updating practice, has granted the drug manufacturer a new drug label that reflects the evidence and the modern standard of care. In places like Ohio, where legislators forced doctors to use the outdated 1990s regimen, women will now be able to get care that aligns with national medical standards. The updated regimen—which has been in place at Planned Parenthood for 10 years—includes a lower dose of mifepristone, which lowers costs and side effects; a higher dose of misoprostol, which increases efficacy; a longer time-frame (from 49 days gestation to 70 days); and the option for medications to be administered by advance practice clinicians like clinical nurse specialists. The new regimen also eliminates an unnecessary follow-up visit.
Research shows that each of these changes either increases the safety and efficacy of medical practice or reduces costs at the same level of efficacy. For example, advance practice clinicians are perfectly capable of completing both medication abortions and early surgical abortions with the same low complication risk as doctors.
In Texas, which over-regulates abortion in almost every way possible, doctors themselves will still have to administer pills in an operating theater. But in Ohio, the label change effectively nullifies a sham safety law and may dramatically change options for women. Prior to the bogus law, 10-15 percent of abortions in Ohio were early induced miscarriages. After legislators forced doctors and women to use the outdated regimen, that dropped to under two percent. With the FDA labeling change, Preterm Clinic in Cleveland says it will make the better regimen available immediately. And in more progressive states, the label change may give women a wider option of providers, especially in rural areas where doctors may be scarce.
Medication abortion is still over-regulated; if science dictated medical practice, at-home therapeutic miscarriage might replace most abortions. Even so, the FDA’s label change is good news for women who would rather not have priests and legislators in the room when they are making medical decisions. Now if only we could now find a way to update some legislators before they come up with their next faith-based “safety” law.