Some pro-abortion legal scholars argue that the FDA should argue that its drug approval decisions are ahead of states in restricting or banning the use of mifepristone. The notion of pre-eminence, derived from the supremacy clause of the Constitution, states that federal law takes precedence over state law when they conflict.
“The Food and Drug Administration has determined that it is safe and effective, and it is in the public health interest for this drug to be readily available,” Parsigian said.
A spokesman for Danco Laboratories, which manufactures mifepristone under the brand name Mifeprex, said the company does not currently plan to challenge state abortion laws that restrict the use of its drug.
The FDA did not immediately respond Wednesday when asked if the agency plans to join future lawsuits challenging restrictions or bans on abortion drugs.
Parsigian indicated that the company’s focus will be on states with restrictions that “interfere with FDA regulations” that allow federal regulators to determine whether a drug is safe and effective before it can be sold in the US.
Mississippi State requirement in effect prior to Rowe vs. Wade it was abolished that patients see a doctor in a hospital setting and have multiple in-person visits – contrary to the FDA’s definition that abortion pills does not need to be issued in person and it can be taken at home — which makes accessing the drug “not entirely impossible, but very, very, very difficult,” he said.
“Patients should have access to drugs that are safe and effective for their FDA-approved use,” the FDA said Friday after the Supreme Court ruled. “In this area, as in all others that the FDA regulates, the best available scientific evidence will continue to guide the Agency’s decision making.”
Statements by President Joe Biden and Attorney General Merrick Garland showed that the availability of abortion drugs will be at the center of the administration’s efforts to address the issue of access to abortion following a Supreme Court decision that struck down the constitutional right to the procedure and returned the issue to the states.
Parsigian said he was not aware of the Justice Department’s legal strategy for access to abortion drugs, but noted that Garland’s statement was consistent with GenBioPro’s argument in the U.S. District Court for the Northern District of Mississippi.
“If a [Garland had] mentioned our costume by name, that would fit exactly what he said,” Parsigyan said. “We do what he says they want to do.”