While federal litigation threatens access to a widely used abortion medication nationwide, Gov. Phil Scott is setting his sights north.
Lawmakers and abortion access advocates are scurrying to craft backup plans as a lawsuit making its way through the federal appeals process could revoke or severely tighten the Food and Drug Administration’s 23-year-old approval of mifepristone, one of two medications used in tandem to induce an abortion. (The U.S. Supreme Court on Friday temporarily blocked lower court rulings, providing continued access to mifepristone as the legal process plays out.) Medication is the least invasive and most common method to carry out an abortion nationwide and in Vermont.
Asked about the lawsuit last week, Scott pointed to Vermont’s neighbor to the north as a beacon of hope. The Republican has historically supported efforts to expand abortion access and said he was “deeply disappointed’ by the fall of Roe v. Wade last summer.
“We are one of three states who have sought to be able to purchase drugs in Canada: ourselves, Colorado and Florida,” Scott said at an April 12 press conference. “And so we’re just waiting for approval from the feds to do so. Now might be the time when they give us the green light, instead of having us wait at the intersection.
“So there are some alternatives that are maybe unique to Vermont. I think we’re going to be OK, but we’ll see.”
The idea hails from a law passed by the Legislature and signed by Scott in 2018, tasking Vermont’s Agency of Human Services with crafting a plan to purchase and import prescription drugs from Canada to Vermont.
The bill was written not with mifepristone in mind, but with lowering prescription drug costs for Vermonters. Nearly five years later, the law has taken on new meaning, presenting a potential avenue to maintain access to mifepristone in the state.
But importing mifepristone — or any drug, for that matter — from Canada appears to be a long way off. Despite passing the Legislature with broad support nearly five years ago, authorization and implementation of the program is stuck in the cogs of state and federal government bureaucracy.
The 2018 bill tasked Vermont’s Agency of Human Services with proposing a Canadian drug importation program to the FDA in 2019, and the agency did just that. But come 2020, the FDA changed its rules for such proposals. According to Scott’s spokesperson Jason Maulucci, “The bar was already very high, and the FDA changed the rules and made it even higher.”
Vermont’s application was deemed by the FDA to be incomplete. Since then, it has remained dormant.
Rachel Feldman, a spokesperson for the Agency of Human Services, pointed the finger at the feds on Tuesday, declining to speculate on “why things with the federal government would take this amount of time.”
“No matter what, we continue to move forward, working with other states, building coalitions, working with these coalitions to continue to find solutions for Vermonters,” she said. “So, again, I cannot speak to the federal process, but we are working in accordance with the law here in the state of Vermont to ensure that we are keeping the ball moving.”
In reality, the ball is in Vermont’s court now.
In the nearly three years that have elapsed since the FDA updated its rules, the Agency of Human Services could have amended and resubmitted its application. But according to Maulucci, the agency has opted not to “because all the money and effort that would go into that application is a very labor-intensive process.”
Instead, the administration has opted to “wait and see” how the feds respond to the two other states, Colorado and Florida, which submitted their applications to implement similar programs.
“It’s kind of been on the back burner for (the Agency of Human Services) because of the limbo that the FDA has put the other states in,” Maulucci told VTDigger on Wednesday. But the mifepristone case “has provoked the governor into asking us to look back into this and refresh the conversation.”
Colorado’s effort to establish a Canadian import program dates back to 2019, and the state submitted its latest proposal to the FDA in December, according to a press release from Gov. Jared Polis’s office. Florida’s proposal has sat dormant, awaiting FDA action, since November 2020.
“When the governor was saying (on April 12) that the feds should move on this, he was broadly referring to the fact that they haven’t responded to any of the three states at all,” Maulucci said.
In a letter sent last fall, U.S. Sen. Marco Rubio, R-Fla., chastised the administration for “fail(ing) to provide (Florida officials) a substantive update since November 2021.”
Florida Agency for Health Care Administration officials “have attempted to reach out to the FDA for months but have received no additional requests for information or a timeline since a meeting in May 2022,” Rubio wrote.
The FDA’s Office of Media Affairs declined to comment Friday in response to repeated requests from VTDigger.
“It is frustrating,” Maulucci said. “Like with a lot of things, federal government moves slowly, and it’s across two administrations, too. It started under the Trump administration, now under the Biden administration.”
Asked whether Vermont and the FDA have recently communicated on the matter, Maulucci said he did not believe so.
Asked the same question, Feldman said, “I’m not sure that it would be prudent to speak about communications occurring during any type of proposal and approval process like this.”
Whether Vermont could even get mifepristone under an approved importation program depends largely on how the Texas lawsuit, which will likely return to the U.S. Supreme Court, is decided. If FDA approval of the drug is pulled wholesale, that could jeopardize importation. But even then, Maulucci told VTDigger, the Biden administration has latitude in enforcing any nationwide bans.
“Maybe the FDA could take an approach like the federal government takes to cannabis, for example, which is federally illegal but not enforced at the state level,” he said.
Mifepristone or not, Vermont’s importation proposal remains in limbo nearly five years after legislators passed the bill nearly unanimously. According to the proposal Vermont submitted to the FDA in 2019, the program could save Vermonters an estimated $1 million to $5 million in prescription drug costs per year.
Asked if the situation was frustrating, Feldman said “maybe it’s not the best timing.”
“We can control what we can control, and what we can control is our submission. We can control our conversations and our partnerships,” Feldman said. “And we can control how we respond to Vermonters with the tools that we have, and we’re nothing if not ingenuitive and creative.”
