Employers and abortion pills, optimism and health policy, and the next round of COVID-19 vaccinations

April 15, 2023

Happy Friday!

Today, I’ll review the implications of the recent Federal District Court decision to set aside the 2000 Food and Drug approval of Mifepristone, a pill used in abortions. I’ll also share some statistics from an op-ed reminding us of real improvements in health care and discuss what upcoming COVID-19 vaccination recommendations mean for employers.

1.     Questions employers might have about the court decisions around FDA approval of mifepristone

Last week saw multiple conflicting rulings in federal court regarding the Food and Drug Administration (FDA) approval and regulations around the use of mifepristone, a drug used for abortions and to treat people who have had a miscarriage. In Texas, Judge Matthew Kacsmaryk ruled that the FDA’s 2000 approval of mifepristone was flawed and issued a nationwide injunction “pausing” this approval.

Meanwhile, in Washington state, Judge Thomas Rice issued an injunction prohibiting the FDA from restricting access to mifepristone in 17 states and the District of Columbia whose attorneys general had filed suit. The Fifth Circuit Court stayed most of Kacsmaryk’s ruling on Wednesday, although allowed restrictions on use including prohibiting prescription by telemedicine or non-physicians and requiring three physician office visits. The conflicting rulings make the Supreme Court likely to step in, and at this point Mifepristone remains available nationwide.

This was accurate as of Friday morning, and it’s possible that there have been additional actions since then.

Here are some questions about the potential impact of these court cases on employers and employer sponsored health insurance:

●      What is mifepristone, and how does it work?

Mifepristone is an oral pill which blocks the hormone progesterone, so the uterine lining cannot maintain the pregnancy. This is usually the first pill given in medical abortions; patients later take a second oral medication, misoprostol, which causes the uterus to contract and expel the dead tissue.

●      Is mifepristone used for medical conditions other than abortions?

Mifepristone is used in people who have had miscarriages - and reduces the need for a procedure to remove dead tissue.

●      Is there an alternative to mifepristone for medical abortions?

Yes. People can take just misoprostol to induce abortions. This causes more cramps and has a slightly lower effectiveness rate. This option is not as helpful for miscarriages. People can also have abortions with a procedure, such as suction, although for early abortions medication is preferred as it is safer.

●      Is mifepristone safe?

Yes.  The drug is widely considered to be safe and effective and has been shown to be safe both in large clinical trials and in widespread community use by millions of women. Various commentators have pointed out that the safety profile of mifepristone is better than that of penicillin or acetaminophen (Tylenol)

●      Is mifepristone available at pharmacies?

Not right now. The FDA is in the process of allowing mifepristone to be dispensed by pharmacists with special training, but that training has not yet been announced. 

●      Will mifepristone continue to be available for treatment?

As of now, yes, although the Appeals Court restrictions will decrease availability by not allowing telemedicine, nonphysician prescribing, or mailing. If the initial ruling is eventually upheld, many believe that the FDA has the discretion to start a new approval process without recalling this medication or sanctioning those who prescribe it. Some states are stockpiling supplies of mifepristone. However, these pills might not be available in all states. 

●      What impact will these decisions have on health benefits?

Summary plan descriptions are generally silent on which individual drugs are covered. Fully insured health plans are governed by state laws, but self-insured health plans are not. Decreased availability of medication abortions could lead to more procedural abortions and could lead to more term pregnancies and deliveries. Prohibition of telemedicine and mailing could mean that more members will use a travel benefit if this is provided. Employers can consult their counsel but need make no changes in their benefit design at this point based on these court cases.

2.     Salute to some public health and health care successes

Some days, it seems like there is a lot of bad news in health policy.  It’s distressing to read about high costs, decreasing life expectancy, and disparities. An op-ed “The Case for Optimism in Health and Health Care” in JAMA Health Forum brought at least a brief smile to my face.

Life expectancy for Americans was under 50 in 1900 and rose to 76.8 in 2000. Even with declines in life expectancy due to COVID-19, our life expectancy remains over 76. The racial life expectancy gap shrunk from 14.6 years to 4 years over the last century.  Much of this was due to improved living standards, as opposed to health care.  Twice as many adults were high school graduates in 2000 compared to 1960, and the poverty rate was cut by almost half. 

Source: Galea, S et al JAMA Health Forum April 6, 2023 LINK

The authors note that life expectancy for 75 year old Americans is similar to those of other developed countries, but we lag in overall life expectancy due to deaths among the young. For instance, our rate of death from automobile accidents has increased more than 20% since before the pandemic, and firearms are now the leading cause of death among those under age 20.

Implications for employers:

-        We have benefited from tremendous improvements in health and life over the last century.

-        Employer-sponsored health insurance is a major source of health coverage for children and young adults. This helps improve member health and provide critical financial protection for families.

3.     FDA and Centers for Disease Control likely to recommend another COVID booster this fall

Multiple sources report that the FDA and CDC are likely to approve and recommend booster doses of COVID-19 vaccinations later this Spring. Other developed countries, including the UK and Canada, have already recommended booster shots. Preliminary reports suggest that boosters will be recommended for those over 65 and those who have severe immunocompromise. There might be a new formulation for COVID-19 boosters for this fall based on changes in predominant strains expected at that point.

In other vaccine news, the Biden Administration announced Project Next Gen, a $5 billion investment in the next generation of vaccines. Targets include nasal vaccines, which prevent transmission of COVID-19, and engineered vaccines that could protect against all coronaviruses (or all influenza viruses), which could mean pharmaceutical companies need not prepare new formulations every time a virus has a significant mutation.

Implications for employers:

-        There won’t likely be any need for special COVID-19 vaccination clinics this spring. Those over 65 and those with immune compromise will be able to gain access to vaccinations from their clinician or a local pharmacy.

-        It’s too early to say whether some employers will want to offer joint COVID-19/influenza vaccination clinics this fall.

-        The federal government has enough of the current boosters left so that spring boosters will be available without cost (although employer sponsored health insurance will pay an administration fee). Employer-sponsored health insurance will likely be responsible for vaccine costs for any reformulated fall booster.