TOUGH PILL TO SWALLOW — When a federal judge ruled on Friday that the abortion pill mifepristone has to be pulled off shelves, he threw politicians, regulators and drugmakers into a state of chaos that’s persisted into this week. Congressional Democrats and at least one Republican are suggesting ignoring the ruling entirely. Over 300 pharmaceutical industry executives signed a letter protesting the decision. And experts say the Food and Drug Administration’s authority has been explicitly undermined. Now, the clock is ticking for the Biden administration, which is intent on keeping the pill — which works in conjunction with misoprostol to induce an abortion — in circulation. U.S. District Court Judge Matthew Kacsmaryk gave the White House a week until a nationwide ban goes into effect; the administration will appeal the ruling to the generally conservative Fifth Circuit Court, asking for a decision by this Thursday at noon. Since U.S. District Court Judge Thomas O. Rice also ruled Friday in Washington state that the FDA has a legal obligation to continue to allow mifepristone on the market, the conflicting rulings suggest a coming battle at the Supreme Court. After paying a clear electoral price for the Dobbs decision last November, prominent Republicans have been mostly mum on Kacsmaryk’s decision. The only likely 2024 presidential contender to weigh in immediately was former Vice President Mike Pence, who said, “The FDA acted carelessly and with blatant disregard for human life and the well-being of American women, and [Friday’s] ruling fixed a 20-year wrong.” To further break down the ruling and its implications on health and politics, Nightly spoke with POLITICO’s Megan Messerly, a health care reporter covering the decision. This interview has been edited. What’s the practical impact of Judge Matthew Kacsmaryk’s decision? Medication abortions will still be an option for patients — but they may be harder to access and result in more side effects. Right now, mifepristone — the drug in question in this lawsuit — is used in conjunction with a second medication, misoprostol, to cause an abortion. Abortion pills are responsible for the majority of abortions in the U.S. and have taken on a key role in aiding abortion access in states where the procedure has been banned since the fall of Roe v. Wade last summer. While abortions can be performed with just misoprostol — a common method in other countries — using just the one drug on its own does tend to lead to more side effects and has a slightly higher rate of patients requiring follow-up surgery. It’s important to note, though, that mifepristone is still accessible right now. Kacsmaryk gave the Biden administration seven days to appeal the decision before it takes effect. But if the appellate court does not intervene, access to mifepristone will be blocked until the case is resolved. And, complicating matters, another federal judge in Washington state ruled in a separate case last week that the FDA can’t roll back access to mifepristone in the 17 states that filed that lawsuit. So what happens next? And how will that conflicting ruling in Washington state play into this week and the continued availability of mifepristone? Even before the decision came down, some abortion providers announced that they were making preparations to switch to the one-dose regimen if mifepristone were to become unavailable. But not all abortion clinics may be able to change their protocols that quickly. At the same time, three states with Democratic governors — California, Massachusetts and Washington — have announced that they have secured stockpiles of mifepristone to ensure the two-dose regimen can continue in their states, and other states have indicated that they are exploring their options. But there’s no getting around the legal uncertainty here: The Washington and Texas rulings are in conflict, and the assumption is that this issue will likely eventually make its way to the Supreme Court. And while Kacsmaryk’s decision was restricted to mifepristone, there’s some thought among legal experts that this could just be the tip of the iceberg and we could see other attempts to challenge the FDA’s approval of vaccines or other drugs. In the wake of the Supreme Court’s Dobbs ruling, the political ramifications of this ruling are enormous. How have the two parties reacted? The response to Friday’s decision has, not surprisingly, mirrored the way we’ve generally seen Republicans and Democrats talk about this issue over the last 10 or so months. Democrats continue to see talking about abortion as a critical political opportunity — the results of the Wisconsin Supreme Court election last week proved the issue remains as salient as ever as we creep up on the one-year anniversary of the Dobbs decision — so it’s no surprise that we saw a litany of Democratic lawmakers and governors immediately pounce on the decision and spring into action. Republicans, by contrast, have been pretty quiet, which, again, parallels the way we saw the GOP talk about the issue during the midterms — that is to say, not very much. It’s a difficult issue for Republicans who have seen, based on polling, that a large majority of people believe medication abortion should remain legal, and that even most members of their party support some, limited access to abortion. Perhaps the most interesting thing about the overall lack of reaction from Republicans is that it flies in the face of what anti-abortion groups have been urging them to do: talk about the issue more. Some lawmakers have suggested publicly that the FDA should simply ignore Kacsmaryk’s decision. What would that look like in practice, and how surprising might such a move be? The FDA could issue guidance saying it will use its enforcement discretion to choose to not go after companies that distribute mifepristone. But doing so poses a couple of problems. One, it’s not clear that would be enough legal assurance for manufacturers, abortion clinics or doctors fearful of prosecution. And two, the FDA under a new administration could change its mind and start prosecuting over abortion pills. At this point, it would be surprising for the FDA to take such a move — just because the Biden administration has signaled it wants to take a more cautious, wait-and-see approach, with litigation in its early days — but some attorneys are still urging the administration to move in that direction. Do you have a sense of the timeline? How soon could this issue come before the Supreme Court and be decided? If the conservative-leaning 5th U.S. Circuit does not grant the Biden administration its requested stay by Friday, it’s likely the FDA will immediately appeal to the Supreme Court and ask it to block Kacsmaryk’s ruling as litigation continues. If the Supreme Court denies that request, mifepristone will lose its FDA approval until the case is resolved. At the same time, the Washington state case may also be appealed — to the more liberal-leaning 9th U.S. Circuit. If the outcomes of both cases continue to conflict at the appellate level, it’s likely the issue will eventually wind up before the Supreme Court. Welcome to POLITICO Nightly. Reach out with news, tips and ideas at nightly@politico.com. Or contact tonight’s author at cmchugh@politico.com or on Twitter at @calder_mchugh.
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