DOJ: "[T]here is nothing modest about upending the decades-long status quo by blocking access nationwide to a safe and effective drug." Expect a ruling — or a SCOTUS filing — Thursday.
"whether the FDA (or any Biden administration agency) would take any actions against those who prescribe, dispense, or administer the drug"
This is really close. But it's important to unbraid federal and state regulatory powers.
The FDA can prevent drugs from being covered by insurance plans, by not issuing its approval indicating that they are safe and effective. (For big pharma, making the onerous process of getting FDA approval reversible by anyone for any reason is an existential threat, and that's why they are now amici. The investment in a new drug only pays off once insurers pay for it.)
Through their medical boards, boards of pharmacy and consumer protection regulations, states determine whether non-approved substances are dispensed by doctors. So, for example, vitamins: Not FDA approved for use, often prescribed and dispensed. That's not illegal. Doctors even give patients substances that harm them, sometimes, but the FDA doesn't stop them--their malpractice claims, license suspension, or criminal charges, do.
As a practical matter, then, what the federal agencies do or don't do is only part of the picture. States that don't otherwise ban abortion will determine whether mifepristone is used in medication abortions, if this ruling is not reversed.
"whether the FDA (or any Biden administration agency) would take any actions against those who prescribe, dispense, or administer the drug"
This is really close. But it's important to unbraid federal and state regulatory powers.
The FDA can prevent drugs from being covered by insurance plans, by not issuing its approval indicating that they are safe and effective. (For big pharma, making the onerous process of getting FDA approval reversible by anyone for any reason is an existential threat, and that's why they are now amici. The investment in a new drug only pays off once insurers pay for it.)
Through their medical boards, boards of pharmacy and consumer protection regulations, states determine whether non-approved substances are dispensed by doctors. So, for example, vitamins: Not FDA approved for use, often prescribed and dispensed. That's not illegal. Doctors even give patients substances that harm them, sometimes, but the FDA doesn't stop them--their malpractice claims, license suspension, or criminal charges, do.
As a practical matter, then, what the federal agencies do or don't do is only part of the picture. States that don't otherwise ban abortion will determine whether mifepristone is used in medication abortions, if this ruling is not reversed.
I have a sinking feeling that the Supreme Court will ultimately end up affirming Judge Kacsmaryk, given its political muscle-flexing of late.