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Abortion pill maker plans multistate legal action to preserve drug access

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Some abortion rights lawyers argue that the FDA should argue that its drug approval decisions prejudge actions by states to restrict or ban the use of mifepristone. The notion of preemption, which stems from the Constitution’s supremacy clause, says that federal law supersedes state law when the two conflict.

“The FDA has determined that it is safe, effective and in the interest of public health that this drug is very readily available,” Parsigian said.

A spokesperson for Danco Laboratories, which makes mifepristone under the brand name Mifeprex, said the company has no plans at this time to challenge the state’s abortion laws that restrict the use of its drug.

The FDA did not immediately comment on Wednesday whether the agency plans to join future lawsuits challenging restrictions or bans on abortion medications.

Parsigian said the company’s focus will be on states with restrictions that “fumble the purpose of FDA regulation,” allowing federal regulators to determine whether a drug is safe and effective before it can be sold in the U.S.

Mississippi’s requirement, previously in effect: Roe v. Wade that patients see a doctor in a hospital setting and have multiple in-person visits — as opposed to the FDA’s stipulation that abortion pills don’t have to be dispensed in person and can be taken at home — makes access to the drug “not quite impossible, but very, very, very difficult,” he said.

“Patients must have access to medications that are safe and effective for their FDA-approved uses,” the FDA said Friday after the Supreme Court delivered its ruling. “In this area, as in all other areas that the FDA regulates, the best available science will continue to guide the Agency’s decision-making.”

Statements by President Joe Biden and Attorney General Merrick Garland have indicated that the availability of abortion medications will be a key focus of the government’s efforts to address access to abortion in the wake of the Supreme Court decision, which overturns constitutional law. on the procedure was withdrawn and handed over to the states.

Parsigian said he is not aware of the Justice Department’s legal strategy regarding access to abortion medications, 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 [Garland had] called our suit by name, it would have fit well with what he said,” Parsigian said. “We’re doing what he said they wanted to do.”

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