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>> remind people at the drug at the center of this f whole thing. >> the drug is mefiprestone, it's been on the market for 20 years so approved in 2000 by the fda. it's basically a regimen with another drug to and early pregnancies. so basically it's been on the market since that time th fda has done periodic reviews of thisstrong and has had cd limits on it . so limits on who can prescribe it, there used to be requirements that you had to prescribe inscperson . but the fda has removed those requirements or at least restrictions over time as we reviewed the safety and effectiveness of it. there's a lot of evidence showing there is it is effective. the college of obstetricians

and psychologists have said it's serious side effects are less than i believe one percent and serious for major adverse effects such as severe infection or bleeding like hospitalization happened in less than three percent of patients so it's safe. it's safer than tylenol and viagra so there's a big element of evidence regarding its safety and efficacy. >> so there's a question on the lawsuits placed against it, what's the nature of the lawsuits and since this is what the supreme court? >> the challenge started off in texas, amarillo. the federal judge there basically the group or the plaintiff led by the alliance defending freedom argued the fda not approve the drug in the first place, it did so without the proper processes even though there's been

evidence of abuse so judge kaczmarek an injunction on the drug but had a delay so the biden administration appealed the decision, fifth circuit said we can't stay on the 2000 approval itself because of the statute of limitations but said that the changes the fda made could be saved so that includes allowing the drug to be prescribed over telemedicine. and also they in 2016 increased when the pill could be used from seven weeks in pregnancy to seven weeks. the appeals court put a stay on those restrictions so basically it goes back to the situation before 2016. the supreme court this alito put a stay on that order so

we could hear from the supreme court as to whether the stay the fifth circuit put in place moves forward or if that will be stayed as litigation and texas continues over the abortion bill. >> what's the impact either way, what could happen particularly for women? >> if the supreme court puts a state it would respect the pill across the country so if wego back to 2016 , that means that patients will have to go to providers in person. and that's very difficult for southern states where there is abortion bands and youhave to travel out of state . then people who are further than seven weeks into pregnancy would not be able to use it. and if there's a larger implications for the fda this is the first time a court has pushed to overturn an fda approval.

something i've seen a lot of folks say is the drug industry attorneys have all pointed to the fda as the gold standard of drug approval because challenging that approval creates a lot of uncertainty for other drugs and could potentially open the door for challenges to other approved drugs. >> i wanted to talk about the reality behind those claims what is the reality depending on this one drug that could impact everythingelse going forward ? >> the challenge in texas is not that this should be removed d it's an abortion pil . it's that the fda used an improper approval process to approve it so ischallenging the approval process itself . it's the major trade group has pushed against it that they are not a party in the lawsuit but they file a brief warning that i believe they

referred to it as an unprecedented assault on the fda approval process so the industry is worried this will provide a lot of uncertainty and when investors spent a lot of money, they do that with the certainty that if they get approved by the fda their drug will be marketed in the us and available for patients to be able to get returns on investments and patients will have access to these drugs if you question the approval process and provides a lot of uncertainty as to whether these drugs are going to be able to make it. >> celine castronova joining us for this conversation. again a decision expected today and if you want to ask her questions open the phone lines at 202 he748-8000 14 republicans, 202 7001 four republicans and 202-748-8000. text us to at 202-748-8000.

where has the fda that on this, what's the case they're making considering all these illegal aspects being wh discussed? >> leading up to the decision the fda was silent because he didn't want to get ahead of the litigation. fda commissioner robert taylor appeared on the house appropriations committee at the end of last month to go over the budget request. he was asked about the drug and declined to comment on the litigation since that decision hhs secretary pierre becerra has called the decision not american and has set arms around the table in terms of the fda response you've seen the biden administration start to push back on judge kaczmarek's decision. the fda released a statement that basically said this is

very concerning andready to defend our safety is the authority over drugs in the united states . >> i'd imagine this to is classified as the number two drug, why so much attention being paid to the one drug? >> mefiprestone is approved for endily pgnancies but it's also use for scarage management but mexiproxyl is approved for a separate condition so attorneys and analysts talk to have said it's impossible to challenge state approval because it has long standing evidence of use in another treatment. and is approved for use. >> i know you don't cover this particularly but justice alito did he make this decision on his own what they needed a four quart ? >> justice alito stayed the order to see my is now before

the full court to weigh in on whether they should stay the order from the fifth circuit. >> mayor: our first call comes from larry in indiana, republican line. good morning, go ahead. >> caller: good morning you all. why are you thinking the pharmacy is more important than the doctor? he's doing the doctor's work instead of you go to the doctor to get checked out, if it wasn't good healthcare you should see a doctor . where will it stop? have a great day.

>> guest: i believe the question was going to the doctor versus a pharmacy. the safety program the fda has is a mitigation strategy so under that and under the current regulation, patients don't have to getit from a certified prescriber so that can be a doctor or a physician . >> ..