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The Pending Dobbs Decision Will Bring Significant Regulatory Challenges for Health Care Providers and Suppliers

As we await the Dobbs decision - expected to repeal Roe v. Wade, Reed Smith has established a working group to prepare clients for a post-Roe regulatory landscape. There are more questions than answers at this point, as many states have existing laws that outlaw abortion and others have prohibitions that are triggered by a repeal of Roe.  There are questions of preemption and potential actions by the Administration and Congress.  Will state legislatures change pharmacist or physician practice acts?  What about private rights of action?  And what about coverage by payors, especially when drugs are used for other purposes?  Or when drugs are used to manage miscarriages?  Who is going to document the varied circumstances that will make the difference between a crime, a lawsuit by a private actor, or no action at all?    

I was thinking about the use of drugs in abortions and the regulatory difficulties in identifying whether dispensing drugs (and which drugs) could create liabilities for pharmacists or prescribers.  A couple of weeks ago I listened to a NY Times Podcast on the History of Abortion in Mexico which discussed the use of an ulcer drug in Mexican abortion clinics.  In light of this example, I thought of a number of questions providers will need to consider if Roe v. Wade is repealed, such as: What about incomplete miscarriages?  Can you prescribe an abortion drug in this situation?  What kind of documentation will be required?

Providers, pharmacies, payors, drug manufacturers and many other companies operating in this industry may face complicated and unanticipated challenges in the wake of the Dobbs decision. These are just the questions our working group will consider over the coming weeks and months.

It’s actually an ulcer medication that often, through word of mouth, women came to realize could also function as an abortion pill. And as time goes on, the medical community gets wind that it’s being used in this way. And they look into it, and they realize, actually, this is really safe. And so, eventually, the World Health Organization recommends it formally, says it’s OK to use this. It’s safe to use this for abortions up to 12 weeks of pregnancy. And Verónica’s hearing about it and realizing, wow.

Tags

dobbs decision, health care & life sciences, post-roe

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