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FDA relaxes guidelines for abortion-inducing drug, flames abortion controversy

The FDA announced a labeling change for the drug Mifeprex®, which, when used together with another drug called misoprostol, will terminate a pregnancy in the early stages. The labeling change will relax certain guidelines in prescribing practices and expand the time in which women can take this drug in order to induce an abortion. This change comes at a controversial time as the Supreme Court just heard oral arguments, and oddly asked parties for additional briefing, in a challenge to the contraception mandate under the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148). At the same time, anti-abortion candidates in the race to the White House have recently fueled the fire with inflammatory remarks while some pro-life proponents are framing the FDA’s change as a political move.

Labeling changes

While the FDA first approved Mifeprex in 2000, the latest announcement outlines a new approved regimen which was found to be safe and effective after a supplement application was submitted by the manufacturer. The FDA stated that the drug may be appropriately used to end a pregnancy through 70 days of gestation and through the following procedure:

  • The ingestion of 200g of Mifeprex on day one;
  • The ingestion of 800mcg of misoprostol 24 to 48 hours after taking the Mifeprex; and
  • A follow-up with a health care provider seven to 14 days after taking the Mifeprex.

The FDA also outlined an appropriate risk evaluation and mitigation strategy (REMS) for Mifeprex, as follows: (1) that it must be ordered, prescribed, and dispensed under the supervision of a health care provider with certain qualifications; (2) that those health care providers must complete a Prescriber Agreement Form before prescribing; (3) that it only may be dispensed in clinics, medical offices, and hospitals; and (4) the provider must obtain a Patient Agreement Form before dispensing it.

Effect

Other than extending the time in which this medication can be prescribed from seven weeks to 10 weeks, the new labeling reflects a change in dosage and procedure that, according to some sources, was adopted by physicians that prescribed Mifeprex off-label long ago. “The change brings the direction for taking the drug . . . in line with what has become standard medical practice in most states: reducing the dosage to 200 milligrams from 600 milligrams, decreasing the number of visits a woman must make to the doctor to two from three, and extending the period when she can take the pill to 10 weeks of pregnancy from seven weeks,” according to the New York Times. There is also evidence that fewer side effects accompany the lower dosage. The same article notes that while the new labeling might be applicable to all states at the moment, at least one state is already working to pass a law that would hold provider’s to the stricter standards imposed in the past.

Context

This FDA approval came at an interesting time for the abortion and contraceptive coverage controversy as, the day before this announcement, the Supreme Court issued an order asking for supplemental briefing in a case on which it had heard oral arguments the previous week and which challenged the contraception coverage mandate of the ACA. Some experts see this as the eight-Justice Court potentially looking for an avenue to strike a compromise on an issue and avoid a 4-4 vote, which would effectively result in the continuation of a circuit split and different laws applying in different jurisdictions on this issue. In this context, pro-life proponents argued that the FDA announcement is a politically fueled move to satisfy the “abortion industry” and pro-choice groups. Others defended it as unrelated to election year politics and as simply part of the FDA’s regulatory responsibility in the face of a supplement drug application.

Religious organizations file a plan B for contraception challenge

Religious non-profits seeking an exemption from the Patient Protection and Affordable Care Act’s (ACA) (P.L. 111-148) mandate that employers pay for contraceptives as part of standard health insurance plans are gearing up for the March 23, 2016, hearing scheduled in front of the Supreme Court. In November, the Court consolidated seven cases challenging the birth-control mandate into one: Zubik v. Burwell. Unhappy religious organizations outside of the seven are not waiting for the Supreme Court’s decision to make their next move, they have already filed another petition before the Court.

In this, the fourth legal challenge of the law to be accepted by the Court since the ACA was passed in 2010, involves religious, non-profit corporations that morally object to the ACA provision that allows their employees to obtain contraceptive coverage through their health insurance, even if those contraceptive products are provided by insurance companies and the government, and not by the institutions. These organizations claim that this indirect participation is offensive and violates their rights to religious freedom. The federal government, however, believes that these institutions have numerous employees who may not necessarily share the beliefs of religious groups that sponsor the non-profits, and these workers would be harmed by the exclusions.

Grace Schools and Diocese of Ft. Wayne

Just in case the Supreme Court does not decide in favor of the religious organizations, two groups that were unsuccessful in front of the Seventh Circuit, Grace Schools and Biola University, and Diocese Of Fort Wayne-South Bend, Inc., filed a petition for writ of certiorari as well. These cases were also decided in favor of the government. On September 4, 2015, the Seventh Circuit issued a decision denying the request for a stay of the enforcement of the ACA’s contraception coverage requirement, holding the accommodation does not impose a substantial burden on their religious beliefs (see 7th Cir Court sticks to its guns overturns injunction for non-profit employers, Health Reform WK-EDGE, September 9, 2015). This petition filed before the Supreme Court requests a hold on the enforcement of the provision, but the Court has not yet responded.

Government

The government also filed a response brief in Zubik v. Burwell. In the brief, the government again claims that the accommodation regulations do not constitute a substantial burden which imposes on the organizations’ religious beliefs. It also states that the accommodation is the least restrictive means of furthering the government’s compelling interest in providing women with full and equal health coverage.

Justice Scalia’s absence

Now that the measure of liberals versus conservatives on the court has changed, the most likely outcome is a four-to-four tie among the justices that would leave the contraceptive mandate in place for the non-profits.

Medicaid an important source of family planning services

States that have expanded Medicaid coverage under the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148) offer considerable family planning options to low-income women who would otherwise be uninsured. The Kaiser Family Foundation (KFF) noted, however, that about 1.1 million women ages 15-49 do not have health coverage due to lack of Medicaid expansion. The ACA also allows states to more easily provide family planning benefits to those who do not qualify for Medicaid.

Medicaid and family planning

State Medicaid programs are required to offer some sort of family planning benefits, and providers are not permitted to implement cost-sharing. The federal government matches state contributions to participating providers at a 90 percent rate as an incentive for states to expand family planning coverage. States may also receive a higher matching rate for some services related to family planning if they are provided along with family planning.

ACA context

States that expand Medicaid under section 2001 of the ACA must provide preventive services at no cost to the patient pursuant to ACA section 1001, which added section 2713 to the Public Health Service Act (P.L. 78-410). These services include 18 different contraceptive methods approved by the FDA, as well as additional services, such as counseling and screening. However, the KFF notes that there is no federal requirement under traditional, full-scope Medicaid, to provide all approved contraceptives, which means that women covered prior to ACA expansions may have different levels of coverage.

Many states have historically provided family planning services to people who do not qualify for traditional Medicaid benefits through Section 1115 waivers, which allow states to implement program changes when approved by CMS. Section 2303 of the ACA allowed states to establish family planning expansion by creating a state plan amendment (SPA) instead of renewing a waiver every five years. In addition, Medicaid expansion under the ACA provides family planning coverage to low-income women who are not yet parents by eliminating categorical eligibility.

The KFF noted that about 10 million women of childbearing age (15-49) were uninsured in 2014, and just under half qualify for Medicaid or ACA subsidies, or could gain coverage under the ACA in the future. About 1.1 million do not have coverage because their state has not expanded Medicaid, while an estimated 1.9 million additional women forego coverage due to immigration status.