books

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet SarpatwariBeatrice Brown, Neeraj Patel, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues.

Below are the citations for papers identified from the month of October. The selections feature topics ranging from a commentary calling for reconsideration of the FDA’s risk evaluation and mitigation strategy (REMS) program for mifepristone, to an analysis of clinical development times for biosimilars seeking FDA approval, to an editorial describing the challenges of using the Defense Production Act to address drug shortages. A full posting of abstracts/summaries of these articles may be found on our website.

Read More

Person typing on computer.

Substantial Obstacles after June Medical Services: ACOG v. FDA

By Rachel Rebouché

In June Medical Services v. Russo, the Supreme Court held that a Louisiana law requiring that physicians obtain admitting privileges at a nearby hospital was unconstitutional. Had the law taken effect, all but one provider would have lost the ability to deliver abortion care in the state. Despite the result, a number of commentators have expressed concern about the future of abortion rights. The source of their concerns is the Chief Justice’s application of the undue burden test—the standard for judging the constitutionality of an abortion restriction—established in Planned Parenthood v. Casey.

Justice Breyer, who wrote the judgment of the Court in June Medical Services, balanced the benefits and burdens conferred by the law, finding that the statute offered no benefit for people’s health and created significant burdens on the delivery of abortion. The admitting-privileges requirement does not protect patients’ safety because complications from abortion are rare and thus rarely will a patient need admission to a hospital. Moreover, admitting privileges, which the district court found each provider had pursued in good faith, do not determine a physician’s competency or credentials.

Although Chief Justice Roberts’s concurrence provided the fifth vote to strike down the law, Roberts wrote separately to emphasize that whether the Louisiana law had any identifiable benefit for patients was immaterial. The Court need only address what burdens the law imposed—if a law establishes “significant obstacles” to abortion. Roberts’s concurrence clearly departs from Breyer’s approach of weighing the law’s benefits against its burdens. Breyer’s formulation would render a law unconstitutional if it had no health benefits but erected a minimal obstacle to abortion care. Roberts’s approach would not: a law only fails the undue burden test—no matter how unsuccessful legislation is in achieving its purported goals—if the restriction renders abortion access substantially more difficult.

Read More

“That I Don’t Know”: The Uncertain Futures of Our Bodies in America

By Wendy S. Salkin

I. Our Bodies, Our Body Politic

On March 30, at a town hall meeting in Green Bay, Wisconsin, an audience member asked then-presidential-hopeful Donald J. Trump: “[W]hat is your stance on women’s rights and their right to choose in their own reproductive health?” What followed was a lengthy back-and-forth with Chris Matthews. Here is an excerpt from that event:

MATTHEWS: Do you believe in punishment for abortion, yes or no as a principle?
TRUMP: The answer is that there has to be some form of punishment.
MATTHEWS: For the woman.
TRUMP: Yeah, there has to be some form.
MATTHEWS: Ten cents? Ten years? What?
TRUMP: I don’t know. That I don’t know. That I don’t know.

Much has been made of the fact that President-Elect Trump claimed that women who undergo abortion procedures should face “some sort of punishment.” Considerably less has been made of the fact that our President-Elect, in a moment of epistemic humility, expressed that he did not know what he would do, though he believed something had to be done. (He later revised his position, suggesting that the performer of the abortion rather than the woman undergoing the abortion would “be held legally responsible.”)

I am worried about the futures of our bodies, as, I think, are many. That a Trump Presidency makes many feel fear is not a novel contribution. Nor will I be able to speak to the very many, and varied, ways our bodies may be compromised in and by The New America—be it through removal from the country (see especially the proposed “End Illegal Immigration Act”), removal from society (see especially the proposed “Restoring Community Safety Act”), or some other means (see especially the proposed “Repeal and Replace Obamacare Act”).

But, I am like President-Elect Trump in this way: Like him, “I don’t know.” I don’t know what to say about what will happen to our bodies or to our body politic. So instead, today, I will take this opportunity to point to one aspect of the changing face of access to reproductive technologies that has already become a battleground in the fight over women’s bodies and will, I suspect, take center stage in the debate over the right and the ability to choose in coming years. Read More