Democrat Attorney General Tom Miller was one of 21 state attorneys general to sign a letter sent to U.S. Dept. of Health and Human Services Secretary Alex Azar II and U.S. Food & Drug Administration Commissioner Stephen Hahn requesting restrictions on abortion medication be lifted due to the COVID-19 pandemic.
“During this unprecedented crisis, we need to ensure that women across the country have access to critical healthcare services,” the letter states. “Steps have already been taken in many states at the behest of the federal government to increase telehealth. Yet, the current FDA REMS create unnecessary barriers between women and abortion care, not only making it harder to find — for example, by prohibiting sale by retail or mail-order pharmacies — but also making it unappealing to prescribe.”
The letter claims that barring the use of telehealth forces women to travel at a time many states and the federal government are urging people to stay home.
Texas and Ohio were singled out in the letter as states where “politicians are using the pandemic to further restrict women’s access to care by deeming abortion ‘nonessential’ healthcare.” Iowa, of course, has also banned surgical abortions as Gov. Kim Reynolds said surgical abortions are not considered essential and are an elective procedure.
“Denying women care and forcing them to travel unnecessarily is not only shortsighted, it is putting women across the country in harm’s way,” the letter says. “Consequently, we urge you to act immediately and remove the FDA REMS designation.”
According to the letter, the FDA subjects Mifepristone to a REMS designation that is “outdated, inconsistent with medical evidence and limits health care providers’ ability to use telehealth and provide this necessary drug, ultimately limiting patients’ access to care.”
The FDA requires under REMS that a patient be handed the Mifepristone at a clinic, medical office or hospital under the supervision of a healthcare provider; the healthcare provider must be registered with the drug manufacturer; and the patient must sign a patient agreement form confirming that she has received counseling on the risks associated with Mifepristone.
“These onerous and medically unnecessary requirements limit healthcare providers’ ability to assist their female patients, particularly during this global healthcare crisis,” the letter says.
If the restrictions are not lifted, then the letter asks enforcement discretion to allow certified prescribers to use telehealth for Mifepristone.
“Women seeking to obtain healthcare cannot abide by such requirements,” the letter says. “These women are putting themselves and their families at risk when they seek out the healthcare that they need, and the federal government must act to ensure that no matter where they live, they can continue to receive necessary, safe and legal abortion care.”
