10 Observations About the Supreme Court Argument in Whole Woman’s Health

Supreme Court

Flickr Creative Commons—Andrew Raff

By Gregory M. Lipper

On Wednesday, the Supreme Court heard oral argument in Whole Woman’s Health v. Hellerstedt, a constitutional challenge to a pair of Texas restrictions on abortion providers. The first provision requires doctors who perform abortions to have admitting privileges from a hospital no more than 30 miles from their clinic; for a variety of reasons, these privileges are very difficult for abortion providers to obtain. The second provision requires abortion clinics to meet the rigorous—and often prohibitively expensive—requirements governing ambulatory surgical centers (this was referred to as the ASC law). If allowed to take effect, these requirements would cause 3/4 of Texas abortion clinics to close and leave just 10 clinics to serve over 5 million women.

The requirements were struck down by the district court, reinstated by the Fifth Circuit, and temporarily blocked by the Supreme Court, which is now hearing the merits of the challenge.

Based on my review of the transcript, here are ten observations about the argument:

1. Justice Ginsburg opened the argument with a procedural curveball.

With the law’s challengers going first, most people presumably expected the argument to start with sharp questioning from, say, Justice Alito. Instead, the Center for Reproductive Rights’s Stephanie Toti got just two sentences out before she was interrupted by Justice Ginsburg. The former civil-procedure professor wanted to know about claim preclusion: in particular, whether the challenges, in this case, to the admitting-privileges requirement were foreclosed by the plaintiffs’ unsuccesful facial challenge, in an earlier case, to those same requirements. This and other procedural inquiries dominated Toti’s argument.

2. All roads lead to the record.

Several of the conservative Justices interrogated Toti about the proof that the law’s requirements would cause clinics to close. Toti provided some infromation about how laws would affect clinics, but also repeatedly alluded to more detailed information that she would supply during her rebuttal. This approach may have prolonged the questioning on this point:

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Policy Surveillance Summer Institute, and a Convening

There are a lot of interesting things going on with policy surveillance.  That’s the term for the systematic, scientific collection and analysis of laws of public health significance. I want to share two in particular with Bill of Health readPSP-SI2016_Registerers.

On June 9-10, the Policy Surveillance Program at Temple University will be hosting its first policy surveillance Summer Institute. We’ve been tasked by the Robert Wood Johnson Foundation with increasing the use of policy surveillance and legal mapping, a process encouraged by the IOM that can promote morerapid diffusion of recommended policies and promising innovations. Historically, the impulse to track law is an old one, but the process for systematically and scientifically collect, code and publish that data is relatively new. It’s essential, though, to the continued integration of public health law practice and legal epidemiology to improve health and well-being (Read more about the transdisciplinary approach to public health law here). Continue reading

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

By Ameet Sarpatwari 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, in-depth analyses, and thoughtful editorials on pharmaceutical law and policy.

Below are the papers identified from the month of February. The selections feature topics ranging from the publication and reporting of clinical trial results across academic medical centers, to the completeness of serious adverse event drug reports submitted to the FDA, to an assessment of the merits of the expiry of brand name trademark protection upon generic entry. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Chen R, Desai NR, Ross JS, Zhang W, Chau KH, Wayda B, Murugiah K, Lu DY, Mittal A, Krumholz HM. Publication and reporting of clinical trial results: cross sectional analysis across academic medical centers. 2016 Feb 17;352:i637.
  2. Doshi P, Jefferson T. Open data 5 years on: a case series of 12 freedom of information requests for regulatory data to the European Medicines Agency. 2016 Feb 11;17(1):78.
  3. Hwang TJ, Kesselheim AS. Vaccine Pipeline Has Grown During The Past Two Decades With More Early-Stage Trials From Small And Medium-Size Companies. Health Aff (Millwood). 2016 Feb 1;35(2):219-26.
  4. Kesselheim AS, Gagne JJ Franklin JM, Eddings W, Fulchino LA, Avorn J, Campbell EG. Variations in Patients’ Perceptions and Use of Generic Drugs: Results of a National Survey. J Gen Intern Med. 2016 Feb 16. [Epub ahead of print]
  5. Lyapustina T, Rutkow L, Chang HY, Daubresse M, Ramji AF, Faul M, Stuart EA, Alexander GC. Effect of a “pill mill” law on opioid prescribing and utilization: The case of Texas. Drug Alcohol Depend. 2016 Feb 1;159:190-7.
  6. Moore TJ, Furberg CD, Mattison DR, Cohen MR. Completeness of serious adverse drug event reports received by the US Food and Drug Administration in 2014. Pharmacoepidemiol Drug Saf. 2016 Feb 10. [Epub ahead of print]
  7. Phillips AT, Rathi VK, Ross JS. Publication of Clinical Studies Supporting FDA Premarket Approval for High-Risk Cardiovascular Devices Between 2011 and 2013: A Cross-sectional Study. JAMA Intern Med. 2016 Feb 22. [Epub ahead of print]
  8. Sarpatwari A, Kesselheim AS. The Case for Reforming Drug Naming: Should Brand Name Trademark Protections Expire upon Generic Entry? PLoS Med. 2016 Feb 9;13(2):e1001955.

Can the United States Use Mortgage-Like Loans to Pay for High Cost Drugs?

By Elizabeth Guo

Pharmaceutical companies are making breakthrough drugs to cure diseases, but no one knows how to pay for them. In 2013 and 2014, FDA approved Solvaldi and Harmoni, which can cure hepatitis C in more than 90% of patients. Solvaldi and Harmoni cost $84,000 and $95,000, respectively, for a standard course of treatment. Government payers and health plans, without a good solution for providing Solvaldi and Harmoni to patients who need them, have restricted coverage of the drug to only those patients with advanced hepatitis C. Last year, Germany approved Glybera, a gene therapy that enables patients with lipoprotein lipase deficiency to produce the deficient enzyme. Glybera is expected to cost $1 million, and it is doubtful whether any payer could shoulder such a price.

Last week, MIT professor Andrew Lo proposed a new way of paying for these high-priced therapies: securitized consumer healthcare loans (HCLs). HCLs would function as mortgages for large healthcare expenses. Because the benefits of some therapies occur upfront, HCLs would allow consumers to pay for the value of their therapies over time, instead of in one upfront payment. The paper proposed two frameworks to govern HCLs. The first is a consumer-funded loan, where the patient borrows a loan to pay the upfront costs of the drug, and pays back the loan over time. The second framework operates similarly to the consumer-funded loan, except that private payers and government agencies assume the debt. Under this model, insurance companies could take the debt associated with the patient’s treatment then shift the debt onto the next payer if the patient changes insurance companies. Continue reading

Minnesota: Leading The Way In Patient Safety

By John Tingle

The UK Government and the Department of Health are taking patient safety very seriously and, since the publication of ‘An organisation with a memory’ in 2000, the UK has like the USA been a world leader in the field of patient safety policies, practices and developments.

In the UK we have a very sophisticated patient NHS (National Health Service) patient safety infrastructure and system along with a NHS Adverse incident reporting system, the NRLS (National Reporting and Learning System). Despite having such a ‘Rolls Royce’, well-established patient safety infrastructure and system, terrible patient safety incidents such as that which happened in Mid Staffordshire a few years ago seem to plague the NHS. Patients died because of poor care and, according to the report, “[t]he Inquiry identifies a story of terrible and unnecessary suffering of hundreds of people who were failed by a system which ignored the warning signs of poor care and put corporate self-interest and cost control ahead of patients and their safety.”Our patient system missed the terrible care failings identified in this inquiry report. We are working hard on improving the system and my posts will provide regular updates on what is happening in the UK, Europe and beyond in patient safety.

Patient Safety: A World Problem Continue reading