President Obama Introduces Evidence Generation Strategy to Reduce High Drug Costs

By Elizabeth Guo

Addressing the high cost of drugs was at the top of President Obama’s list in his fiscal year 2017 budget, released last week. Many of his proposals were familiar. The President hoped to increase manufacturer contributions to prescription drug coverage under Medicare Part D and wanted to shorten the length of biologic market exclusivity from twelve to seven years. These proposals were also in the President’s fiscal year 2016 budget but were not put into place.

However, the budget also included a number of surprising, new proposals that underscore how post-market evidence might play an increasing role in controlling drug prices in coming years. Rachel Sachs has written about the role that the Centers for Medicare and Medicaid Services (CMS) can play in keeping down drug prices, and it seems like some of these ideas are gaining traction:

Modify reimbursement of Part B drugs. The White House estimates that changes to Medicare Part B payments could save the country $7.75 billion over ten years. Medicare Part B covers drugs and services dispensed in an outpatient setting. Many of the most expensive biologic drugs are currently covered under Medicare Part B. The budget proposal did not elaborate on how the White House hopes to change Part B payments, but the proposal likely refers to recommendations released by the Medicare Payment Advisory Commission (MedPAC) last June. MedPAC’s 2015 report recommended that Congress link Part B payments to clinical effectiveness evidence. For example, the government could group drugs with similar health effects and pay all drugs in each group the rate of least costly product in the group. This approach relies on having reliable clinical effectiveness data so that researchers can easily compare the relative effectiveness of two or more drugs. Continue reading

TOMORROW (2/18)! Assessing the Viability of FDA’s Biosimilar Pathway

16.02.18, FDA Biosimilars Pathway posterAssessing the Viability of FDA’s Biosimilar Pathway
February 18, 2016 12:00 PM
Pound Hall, Room 100
Harvard Law School
1536 Massachusetts Ave., Cambridge, MA


The 2010 passage of the Biologics Price Competition and Innovation Act was intended to create a pathway for the approval of biosimilar drugs, to bring to market less expensive versions of innovators’ biologic therapeutics in the same way the Hatch-Waxman Act has worked so well for FDA approval of generic small-molecule drugs. But the Act has been mired in a host of statutory, regulatory, and scientific complication and delays, and five years later, the FDA has approved just one biosimilar product.  Continue reading

Working conference on ethics of randomized trials in development economics and health policy

An opportunity for graduate students and young scholars; application deadline March 11

Applications are invited for participating in a five day working conference and summer school on ethical issues posed by randomized trials in development economics and health policy, to be held June 20-24 at the beautiful Brocher Foundation villa in Hermance, Switzerland.

The conference offers trainees and younger scholars in development economics, global health, ethics, and related fields and areas of practice an opportunity to participate in five full days of debate and discussion with leading scholars. Those include Angus Deaton (Princeton; this year’s Nobel Laureate in Economics), Michael Marmot (UCL; current President, World Medical Association), Josh Angrist (MIT), Adam Wagstaff (World Bank), Tyler Cowen (George Mason University), Will MacAskill (University of Oxford), Nancy Cartwright (Durham), and many others.

Selection of the applicants will be made by the conference directors, Profs. Nir Eyal and Daniel Wikler (Harvard University), Dr. Anders Huitfeldt (Stanford University), Prof. Samia Hurst (University of Geneva).

The application deadline is March 11, 2016. Further information is available at the Brocher website. For remaining questions, please email Dr Huitfeldt, at

Expanding Coercive Treatment Is The Wrong Solution For The Opioid Crisis

By Leo BeletskyWendy Parmet, and Ameet Sarpatwari

Cross posted from Health Affairs Blog

Amidst a surging crisis of opioid abuse and overdoses, many policymakers have called for expanded use of coercive treatment. Many states, including Massachusetts, already allow physicians, police, and court officers to seek a court order authorizing involuntary addiction treatment (formally referred to as substance use disorder (SUD)). But new legislation, The Act Relative to Substance Use Treatment, Education, and Prevention (STEP) currently before the Massachusetts state legislature (H.3944) could expand the scope of involuntary treatment and reduce judicial oversight.

This proposal is an ill-considered response to a public health crisis. To be sure, policymakers face an understandable pressure to take decisive action. But this approach fails to balance that imperative for speed and public confidence with sound scientific, legal, and ethical principles.

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The Testosterone Rule Strikes Again – New Policy to Address Transgender Athletes

New Guidelines issued by the IOC (International Olympic Committee) offer a new policy for the participation of transgender athletes in sports competitions. According to the new policy, transgender athletes should be given the option to compete without having to undergo genital re-construction surgery. Female to Male (F-M) transgender athletes will be allowed to compete without further limitations, however Male to Female (M-F) transgender athletes would be allowed to compete only after receiving hormonal treatment intended to keep testosterone levels under a fixed threshold for at least a year before the competition. This is a significant change to the previous guidelines, which recommended that transgender athletes be eligible to compete only after a genital re-construction surgery and two years of hormonal therapy. The committee explained that the change of policy was due to “current scientific, social and legal attitudes on transgender issues”. The overriding objective of all policies according to the IOC was ‘fair competition’, so whereas genital appearance was not considered to affect fairness, testosterone levels are still understood to generate a competitive edge.

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‘The Week in Health Law’ Podcast

By Nicolas Terry

This week we interviewed Charles Ornstein, a senior reporter for ProPublica covering health care and the pharmaceutical industry. ProPublica has been at the cutting edge of twihl 5x5technology, health, and privacy reporting, and Ornstein’s work there has exposed both the personal narratives and hard data behind an American epidemic of privacy violations. We cover some of his recent hits in this conversation, and reflect on what it would take to see an effective health privacy regime in the US. HITECH geeks will love the discussion of “accounting of disclosures” at the end.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at iTunes, listen at Stitcher RadioTunein and Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw

Medicaid and the Primaries

By Emma Sandoe

The candidates have said little about health care over the 2016 campaign season. But the debates over Medicaid expansion continue to loom large over the primary elections as the politics within states are put on display. In all of the states that are showcasing early primaries, the state legislatures are actively debating Medicaid policy.


Iowa was the second state to expand Medicaid using the 1115 waiver authority. Since the state expanded coverage about 116,000 Iowans have gained Medicaid coverage through expansion or through the other Medicaid eligibility programs that the state offers.

Separate from the conversation about expansion the governor has proposed a controversial change to move all of the Medicaid beneficiaries onto private health insurance plans paid for by Medicaid. This ambitious plan required additional complexities such as setting up provider networks and informing beneficiaries of the change. The federal Centers for Medicare & Medicaid Services (CMS) recently asked the state to delay the implementation date. In other states, the private plans are phased in by population group (pregnant women, children, people with disabilities, etc) and often people with disabilities are excluded. Private insurers are often not equipped to provide services to high need individuals and the payment system incentivizes these high utilizers to be denied care Continue reading

High Deductibles and Consumer-Based Health Care

By Zack Buck

Last week, the New York Times highlighted a recent study by Zarek C. Brot-Goldberg, et al., with fascinating implications for cost control within American health care. The paper, entitled, What Does A Deductible Do? The Impact of Cost-Sharing on Health Prices, Quantities, and Spending Dynamics, and posted by the National Bureau of Economic Research, shares that while deductibles do cause patients to use less health care, the type of health care that patients cut represents both high-quality, high-value care as well as low-value, wasteful care.

The study tracks the results of an insurance switch by a large employer—from a plan that provided free health care to a high deductible plan for its employees—and noted that the switch reduced overall spending by about 12 percent. However, while spending dropped, beneficiaries were cutting the wrong type of health care. The authors concluded that there was “no evidence of consumers learning to price shop after two years in high-deductible coverage,” finding that the beneficiaries “reduced low-value medical services and medically important ones at about the same rate, raising questions about their long-term health.” According to the authors, “90 percent of all spending reductions occur[red] in months that began under the deductible.”

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TOMORROW (2/10) Fetal Pain: An Update on the Science and Legal Implications

fetalpain_slideFetal Pain: An Update on the Science and Legal Implications
February 10, 2016 12:00 PM
Wasserstein Hall, Milstein East C
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Amanda Pustilnik, JD and Maureen Strafford MD will discuss fetal pain, including advances in neuroscience and treatment and their implications for the law. 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 January. The selections feature topics ranging from the relationship between pharmaceutical marketing and innovation, to an analysis of off-label promotion rulings by the United Kingdom Prescription Medicines Code of Practice Authority, to the trends in direct-to-consumer advertising of prescription pharmaceuticals. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Arnold DG, Troyer JL. Does Increased Spending on Pharmaceutical Marketing Inhibit Pioneering Innovation? J Health Polit Policy Law. 2016 Jan 5. [Epub ahead of print].
  2. Barbour V, Burch D, Godlee F, Heneghan C, Lehman R, Perera R, Ross JS, Schroter S. Characterisation of trials where marketing purposes have been influential in study design: a descriptive study. Jan;17(1):31.
  3. Choudhry NK, Denberg TD, Qaseem A; Clinical Guidelines Committee of the American College of Physicians. Improving Adherence to Therapy and Clinical Outcomes While Containing Costs: Opportunities From the Greater Use of Generic Medications: Best Practice Advice From the Clinical Guidelines Committee of the American College of Physicians. Ann Intern Med. 2016;164(1):41-9.
  4. Greene JA, Anderson G, Sharfstein JM. Role of the FDA in Affordability of Off-Patent Pharmaceuticals. 2016 Jan 4. [Epub ahead of print].
  5. Kesselheim AS, Hwang TJ. Breakthrough Medical Devices and the 21st Century Cures Act. Ann Intern Med. 2016 Jan 19. [Epub ahead of print].
  6. Lieberman DA, Polinski JM, Choudhry NK, Avorn J, Fischer MA. Medicaid prescription limits: policy trends and comparative impact on utilization. BMC Health Serv Res. 2016;16(1):15.
  7. Vilhelmsson A, Davis C, Mulinari S. Pharmaceutical Industry Off-label Promotion and Self-regulation: A Document Analysis of Off-label Promotion Rulings by the United Kingdom Prescription Medicines Code of Practice Authority 2003-2012. PLoS Med. 2016;13(1):e1001945.
  8. Wu MH, Bartz D, Avorn J, Seeger JD. Trends in Direct-to-Consumer Advertising of Prescription Contraceptives. 2016 Jan 22. [Epub ahead of print].

Zika Messes with Texas

Photo: Texas + Fence

Flickr Creative Commons—Adam Simmons

By Gregory M. Lipper

For an ambitious, aggressive disease like Zika, Texas is an ideal home. Earlier this week we learned that Zika—a nasty virus that has spread to over 25 countries—was transmitted by sex to a resident of Dallas. Six more cases of Zika have also been confirmed in Harris County, Texas. The appearance of Zika in Texas may be happenstance, but Texas’s health policies will make it easier for Zika to spread. Among other problems, Texas (1) fails to teach students about safe sex and reduces access to affordable, effective contraceptives; (2) has blocked access to Medicaid for up to 2 million low-income residents; and (3) is trying to restrict if not eliminate access to safe abortion. Not a bad place for a communicable disease that can spread through sex and cause birth defects.

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Et tu, CDC?

The CDC has a new message for women: stop drinking alcohol unless you’re on birth control.

Fetal Alcohol Spectrum Disorders (FASD) are birth defects that can occur when women drink during pregnancy, and may include physical, psychosocial, and intellectual disabilities. There’s no disagreement in the health care community that FASD are a tragedy, all the worse because they are 100% preventable. However, the amount of alcohol consumption that is considered safe for pregnant women has long been the subject of (unresolved) debate, though most advice tends towards complete abstention.

This week, the CDC took this conversation in a new direction, initiating a FASD prevention campaign that implicates all women of childbearing age by claiming that 3 million women are at risk of injuring a baby because they are “drinking, having sex, and not using birth control”. As a strong supporter of their mission, I was dismayed to see the CDC join the long list of actors holding women individually responsible for public policy goals. To be clear, the concern about FASD is well founded, and women’s health behaviors are an important part of prevention. But the singular focus on women’s personal decisions without regard for the other factors driving alcohol consumption during pregnancy is disappointing from the nation’s leading public health agency.

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Blinding as a Solution to Bias

Blinding Bias

We’re pleased to announce that a new book by Petrie-Flom Center affiliates Christopher Robertson and Aaron Kesselheim will be available this week.  The edited volume — Blinding as a Solution to Bias: Strengthening Biomedical Science, Forensic Science, and Law — grew from a 2013 conference at Harvard co-sponsored by the Petrie-Flom Center.  From the fascinating history of blinding (starting in Ben Franklin’s living room to test the healing powers of Mesmerism) to the sham surgeries being used today, and the future novel uses of blinding in the courts, the book moves the debate forward.  What are the advantages and limitations of blinding compared to other solutions for biases? How can we quantify the biases in unblinded research? Can we develop new ways to blind decision-makers?  What are the ethical problems with withholding information?  Fundamentally, questions about who needs to know what open new doors of inquiry for the design of scientific research studies, regulatory institutions, and courts.  With a foreword by Larry Lessig, the book surveys the theory, practice, and future of blinding, drawing upon leading authors with a diverse range of methodologies and areas of expertise, including medicine, law, forensic sciences, philosophy, economics, psychology, sociology, and statistics.  It is available for pre-order from the publisher and

Liability for Mobile Health and Wearable Technologies

Lindsay Wiley and I just posted Liability for Mobile Health and Wearable Technologies that is forthcoming in Annals of Health Law. As we argue–Most of the legal commentary regarding mobile health has focused on direct regulation leveraging existing laws and regulators such as HIPAA privacy through HHS-OCR or device regulation by the FDA. However, much of the mobile health revolution likely will play out in lightly regulated spaces bereft of most of the privacy, security, and safety rules associated with traditional health care. This article examines the potential for common law liability models to bridge these gaps (even on a temporary basis).
Download the paper on SSRN here.

Does the NAM Recommendation of Sex Selection for Mitochondrial Replacement Therapy Violate the Equal Protection Clause (Part III on my take on the NAM report)

As I said in one of my earlier posts today one of the most interesting parts of the NAM report on mitochondrial replacement therapy was its recommendation that only male embryos be implanted and not female ones. The argument is that this will eliminate the risks of germ-line transmission of anything untoward. I will leave it to others more versed in the risk factors to discuss whether this is an over-reaction (the UK did not adopt this in their recommendation) or reasonable. In the last post I discussed why politically/ethically this may get them in some hot water, but here  I want to raise a different question. Would such a recommendation be unconstitutional?

If FDA were to adopt this rule it would clearly be state action. It seems to be a state-law that favors one gender (males) over another (females) in that only males can be produced in this way. If that is right, under existing Supreme Court precedent it would be judged under “intermediate scrutiny.” To pass intermediate scrutiny, the challenged law must further an important government interest by means that are substantially related to that interest. Would this rule satisfy that test? Continue reading

‘The Week in Health Law’ Podcast

By Nicolas Terry

This week featured Deven McGraw, Deputy Director for Health Information Privacy at the U.S. Department of Health and Human Services’ Office for Civil Rights. Deven has been an influential figure in health law for years, both as a partner at Manatt, Phelps & Phillips, LLP (and co-chair of its Privacy and Data Security practice) and as head of CDT’s Health Privacy Project.

twihl 5x5Our lightning round featured Nic’s takes on a recent certificate of need case, a JAMA article on high-deductible plans, and superbugs on duodenoscopes. Frank covered the NY Times’s blockbuster article on drug shortages, and Politico’s data-driven angle on Biden’s “cancer moonshot.”

We then focused on Deven’s work, covering many topics in health privacy and security. OCR hopes that its recent guidance on access to health records will empower patients. Cloud computing and the “internet of health things” are huge concerns. OCR is innovatively offering FAQ pages for developers and others on the frontlines of health care’s technological advance, and welcomes their (and your) questions!

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at iTunes, listen at Stitcher RadioTunein and Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw

Why Senator Markey’s Message Hurts Children

Last week, Senator Edward Markey (D-MA) placed a hold on the Senate’s nomination of Robert Califf’s as head of the Food and Drug Administration (FDA). The move was less against Califf and more as political leverage against FDA’s approval of OxyContin. In August 2015, FDA approved OxyContin, a prescription painkiller, for pediatric patients ages 11 to 17. OxyContin is the painkiller most associated with United State’s prescription drug abuse epidemic, accounting for an increase in drug overdose and death over the last decade. FDA’s approval of OxyContin for children drew concern from Markey and others that the approval would lead to an increase in drug misuse for children and their family members. Markey, who has prioritized the fight against opioid addiction in his legislative agenda, hopes he can use the hold to convince FDA to reverse its August decision.

Senator Markey’s message is well intentioned, but may ultimately do more harm than good for children.

Before FDA approved OxyContin in August, children who suffered from severe, chronic pain due to cancer, extensive trauma, or serious surgeries had few drugs approved to treat their pain. Many physicians treating severe pain in children prescribed OxyContin off-label, without proof that OxyContin could safely and effectively treat children. These physicians often relied on their experience or intuition to not under or overprescribe the drug. FDA’s approval in August meant the pharmaceutical manufacturer finally provided physicians with instructions, backed by controlled studies, explaining how physicians could safely use OxyContin to treat children with severe pain. Continue reading

Breaking News: NAM Releases Report on Mitochondrial Replacement Therapy (Part II My First Take)

By I. Glenn Cohen

My last post was a summary of the NAM’s Recommendations on Mitochondrial Replacement Therapy (MRT). Now here is my take on the report. But keep in mind the report was just released and all I could give it was a quick read, so these are really more like initial impressions: Continue reading