A New Cholesterol-Lowering Drug at What Price?

By Kate Greenwood
[Cross-posted at Health Reform Watch]

This summer, the Food and Drug Administration (FDA) is expected to approve the first entries in a new class of drugs that lower patients’ low-density lipoprotein (LDL) cholesterol levels by more than half, even those patients who are already taking other cholesterol-lowering medication. The new drugs are biologics—monoclonal antibodies—that target, and inhibit, the gene proprotein convertase subtilisin–kexin type 9 (PCSK9). In mid-March, the New England Journal of Medicine published the results of important studies (here and here) of the two PCSK9 inhibitors that the FDA is expected to pass judgment on this summer. These studies—of Repatha (evolocumab), which is sponsored by Amgen, and Praluent (alirocumab), which is sponsored by Sanofi and Regeneron—suggest, but do not definitively establish, that PCSK9 inhibitors will reduce not just LDL levels, but also a patient’s chance of a major cardiovascular “event”, like a heart attack or stroke.

The race to approval between Amgen and Sanofi and Regeneron has been dramatic. (Pfizer also has a monoclonal antibody PCSK9 inhibitor in development, but it has lagged behind the two leaders.) As John Carroll reported at FierceBiotech last summer, Sanofi and Regeneron jumped ahead of Amgen when they purchased a priority review voucher from BioMarin for $67.5 million dollars. BioMarin was awarded the priority review voucher, which shrinks the time the FDA takes to approve a drug from ten months to six, because it developed and sought approval for a treatment for a rare pediatric disease. Per the Wall Street Journal, “[t]he voucher was the first to be issued under the pediatric incentive program, and also the first to change hands.”

As I mentioned earlier this week here, speculation has begun about what the price of the new PCSK9 inhibitors will be. Weighing in favor of a high price, the evidence of their efficacy is impressive and growing. The drugs hold particular promise for patients who cannot tolerate statin medications, or whose cholesterol cannot be controlled by statins alone. And, they are biologics, which are more expensive to produce than small-molecule drugs. On the other hand, PCSK9 inhibitors are not without safety concerns. In addition, patients will have to inject themselves with the new drugs, which some will find undesirable (although some might prefer a once- or twice-a-month injection to a daily pill regimen). Finally, the new drugs will have to compete with generic statins.

Payers are very concerned. Continue reading

Recommended Reading: New Empirical Analysis of False Claims Act Whistleblower Litigation

By Kate Greenwood
[Cross-posted at Health Reform Watch]

Late last year, the Columbia Law Review published David Freeman Engstrom’s Private Enforcement’s Pathways: Lessons from Qui Tam Litigation, the fourth in a series of articles Professor Engstrom has written on the growth and evolution of qui tam litigation. (My colleague Associate Dean Kathleen Boozang wrote about the first three at Jotwell, here.) Private Enforcement’s Pathways, like the articles that precede it, brings a welcome dose of data and empirical analysis to a controversial area of the law, the debate over which has at times generated more heat than light.

Professor Engstrom’s analysis rests on a database he built containing information on the roughly 6,000 unsealed FCA cases that have concluded in a litigated judgments or settlement since 1986. In response to Freedom of Information Act requests, the Department of Justice provided information on the judicial district in which each case was filed, the date that DOJ decided whether or not to join each case, and the outcome of each case (including the amount, if any, that the government recovered and the whistleblower’s share of that recovery). DOJ also provided the date of filing for the 3,000 cases filed since 1986 that remain under seal, as well as for the 6,000 unsealed cases. From PACER, Professor Engstrom retrieved information on the parties, law firms, and individual lawyers involved in each unsealed case. Continue reading

A “Money Blind” for Research into Maternal-Fetal Medication Risk?

By Kate Greenwood
[Cross-posted at Health Reform Watch]

A week ago, the Food and Drug Administration announced the results of a review of the medical literature it conducted in response to “recent reports questioning the safety of prescription and over-the-counter (OTC) pain medicines when used during pregnancy.” The literature, FDA determined, is inconclusive. FDA found that all of the studies had “potential limitations in their designs” and that “sometimes the accumulated studies on a topic contained conflicting results that prevented us from drawing reliable conclusions.” As a result, the FDA chose not to update its current recommendations. The agency emphasized, though, that the use of pain medication should be “carefully considered” by pregnant women and their physicians.

One of the reports that triggered the FDA’s review was no doubt this study, published in JAMA in April 2014, which found an association between prenatal exposure to acetaminophen and a higher risk of developing attention deficit hyperactivity disorder. The study led to headlines like Acetaminophen Use While Pregnant Leads to ADHD, Study Says and Mom’s Tylenol Use, Dad’s Age Are Latest Suspects on ADHD Front. At the New York Times’ Motherlode, KJ Dell’Antonia wrote: “If there is a pregnant woman out there willing to take Tylenol after reading this research — or just the associated headlines — I’d be surprised.” But there are serious risks associated with other pain medications, too. Tylenol has long been considered a relatively safe option. Even white-knuckling it is not risk free. As the FDA pointed out in its announcement, untreated severe and persistent pain increases the change that a pregnant woman will develop anxiety, depression, and high blood pressure.

Continue reading

The Ethics of Using Placebo Controls in Ebola Clinical Trials

[Blogger’s Note: I am very pleased to share this post by my colleague at Seton Hall Law, Carl Coleman. This post was cross-posted at Health Reform Watch.]

By Carl H. Coleman

With well over 5,000 global deaths from Ebola already reported, drug developers are working fast to begin human clinical trials of promising experimental treatments.  Earlier this month, US government officials announced plans to launch a study of multiple Ebola interventions at the NIH Clinical Center, Emory University, and the University of Nebraska.  Shortly thereafter, the international relief organization Médecins sans Frontières (MSF) announced that it would soon begin testing of three experimental interventions at its treatment centers in West Africa, in collaboration with a coalition of European partners and the World Health Organization.

As predicted in an earlier blog post, a major area of contention in these trials involves the ethical acceptability of using placebo controls.  Plans for the US study are to give some participants the experimental drugs and others placebos, with everyone receiving the best supportive care available, such as fluid replacement and medications to fight off other infections.  In the MSF trials, by contrast, none of the participants will be given placebos; instead, everyone will receive one of three different experimental interventions.

From a methodological perspective, it is easy to see why the designers of the US study have chosen to use placebos.  Placebo-controlled trials are widely considered the “gold standard” of clinical research.  Using placebos makes it possible to identify the extent to which observed outcomes in participants are the result of the experimental intervention, as opposed to factors such as access to better health care facilities, receipt of supportive care, or psychological expectations (the so-called “placebo effect”).  Continue reading

Addressing the Dearth of Data on Fetal Death: The Role of Hospitals*

By Kate Greenwood
[Cross-posted at Health Reform Watch]

As I have blogged about before, including last year here, research and public health interventions aimed at preventing stillbirth are stymied by a dearth of data. In an article in this month’s Maternal and Child Health Journal, Erica Lee and colleagues at New York City’s Bureau of Vital Statistics evaluate data collection by New York City hospitals before and after the city’s implementation, in 2011, of the 2003 United States Standard Report of Fetal Death. The Standard Report aids reporters by setting forth “a series of checkboxes for potentially fatal fetal and maternal conditions.” Unfortunately, Lee’s research reveals a persistent and widespread failure to collect basic information when a baby dies in utero.

In New York City, Lee found, “fetal death reports frequently supplied ‘intrauterine fetal demise’, ‘stillbirth’, or other inadequate terms as causes of death.” As Lee points out, words and phrases like this, which merely describe what happened without assigning a cause to it, do not inform public health research. In many cases, of course, what caused a stillbirth truly is unknown. Prior research suggests that this is true 10-40% of the time. In New York City, though, even after the implementation in 2011 of the Standard Report, the percentage of reports with ill-defined causes of fetal death remained troublingly high, at 61%. There was also substantial variation from hospital to hospital. The hospitals that were the best reporters assigned a specific cause 87% of the time, while the worst assigned a specific cause 0% of the time.

As Lee and her colleagues explain,

“public health research aimed at preventing fetal deaths is substantially limited by the data available, particularly poorly-defined and nonspecific causes of fetal death. These data quality concerns have forced researchers to conduct resource intensive cohort studies and/or time consuming chart audits to fully understand the causes behind fetal deaths rather than relying on the more readily-available and routinely collected fetal death records.”

Lee suggests that the variation that exists between hospitals represents an opportunity for improvement, which leads to the question of what policy levers could be used to bring all hospitals up the level of the top performers.  Continue reading

Doctors’ Decision-Making: Regression Proof?

By Kate Greenwood
[Cross-posted at Health Reform Watch]

As I have blogged about before, last year, in Kaiser v. Pfizer, the First Circuit joined the handful of courts to have approved a causal chain of injury running from a pharmaceutical company’s fraudulent promotion, through the prescribing decisions of thousands of individual physicians, to the prescriptions for which a third-party payer paid.  To establish but-for causation in the case, Kaiser submitted an expert report and testimony from Dr. Meredith Rosenthal, a health economist at the Harvard School of Public Health. Dr. Rosenthal conducted a regression analysis to determine the portion of physicians’ prescribing of the drug Neurontin that was caused by the defendant’s fraudulent promotion, arriving at percentages ranged from 99.4% of prescriptions for bipolar disorder to 27.9% of prescriptions for migraine.

Pfizer argued that Dr. Rosenthal’s regression analysis should not have been admitted (and at least suggested that such an analysis should never be admitted in a third-party payer case) because regression analysis could not “take into account the patient-specific, idiosyncratic decisions of individual prescribing physicians.” Dr. Rosenthal’s report, the company argued, “merely demonstrated ‘correlation’ and not ‘causation.’”  The First Circuit disagreed, upholding the lower court’s determination that the challenged evidence was admissible under Federal Rule of Evidence 702, because “regression analysis is a well-recognized and scientifically valid approach to understanding statistical data” and because it “fit” the facts of the case.

Eric Alexander, a partner at Reed Smith, made a similar argument to Pfizer’s when he critiqued a decision issued in July in a third-party payer case in the Eastern District of Pennsylvania. Writing at the Drug and Device Law blog, Alexander criticized the court for failing to address “the fundamental—to us—issue of whether an economist [Dr. Rosenthal was the plaintiff’s expert in that case, too] can ever determine why prescriptions were written.”  Alexander points out that “[t]o get to millions of dollars of revenue from prescriptions, many physicians have to prescribe the drug to many patients[,]” and those physicians can “pretty much do what they want[.]” Economists, Alexander argues, should not be allowed to by-pass this complexity and simply “assume” causation.

I would argue that, as idiosyncratic as physician decision-making may be, it is not uniquely so.  Continue reading

What’s Next If the FDA Holds the Line on Social Media?

By Kate Greenwood
[Cross-posted at Health Reform Watch]

Earlier this week, the Food and Drug Administration announced that it was reopening the comment periods for the two draft guidances on the use of social media to promote prescription drugs and medical devices that it released in June:  Internet/Social Media Platforms with Character Space Limitations: Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices and Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices. Both guidances have drawn criticism from industry and observers, with the FDA being charged with, in the words of Pharmaguy at the Pharma Marketing Blog, “not being technically savvy enough to understand the nuances of social media and search engine advertising.”

In the draft guidance on social media platforms with character space limitations, such as Twitter and sponsored links on Google and Yahoo, the FDA states that “if a firm chooses to make a product benefit claim, the firm should also incorporate risk information within the same character-space-limited communication.” The draft guidance would allow companies to limit the risks that are presented within a character-and-space-limited communication to those that are the most serious, as long as the communication also includes a direct hyperlink to a destination (for example, a landing page) that is devoted exclusively to a complete discussion of the product’s risks. The FDA emphasizes in the draft guidance that “[i]f an accurate and balanced presentation of both risks and benefits is not possible within the constraints of the platform, then the firm should reconsider using that platform for the intended promotional message (other than for permitted reminder promotion).”  In the first round of comments, PhRMA commented that the amount of information that companies are required to include in a single communication “would make the use of Twitter and comparable platforms impossible in all but the rarest cases.” With regard to sponsored links, PhRMA also noted that the guidance assumes that advertisers have more control than they in fact do over “the appearance – and order of appearance – of information on such platforms.”

It will be interesting to see whether and how the FDA responds to these comments, as well as to any additional comments filed during the period that comments are reopened, which ends on October 29th. If the agency holds the line (as I think it should) and continues to require that companies provide at least some balance between risks and benefits in all advertising and labeling, regardless of platform, companies will no doubt (continue) to look for alternatives.  Continue reading

Lessons from Miss Idaho: Greater Acceptance of (but Not Necessarily Greater Access to) Diabetes Devices

By Kate Greenwood
[Cross-posted at Health Reform Watch]

Given the health law and policy topics that are this blog’s usual fare, some of you may have missed the fact that earlier this month the eighty-eighth annual Miss America pageant was held here in New Jersey, at Boardwalk Hall in Atlantic City. And you may have also missed it (I did) when, this past July, Miss Idaho, Sierra Sandison, a Type 1 diabetic, became a social and traditional media sensation after she competed in the swimsuit competition with her insulin pump clipped to her bikini bottom, visible for all to see. Sandison started a hashtag, #showmeyourpump, inspiring Type 1 diabetics from around the world to post photos of themselves with their pumps.

Although Sandison was the first contestant to compete in the Miss America pageant with her pump visible, she is not the first contestant with Type 1 diabetes, or the first to rely on a pump. In 1998, both Deana Herrerra, Miss New York, and Nicole Johnson, Miss Virginia, had the disease, and both relied on pumps to control it. Johnson went on to be crowned Miss America 1999, with a platform of diabetes awareness. Johnson explained to the Philadelphia Inquirer that, before getting the pump, “‘I stuck myself four or five times a day. I was getting scar tissue. I was feeling depressed, and I thought, `I’m never going to have an iota of freedom.'” Since getting the pump, Johnson said, “‘Now, I control the diabetes.”’

Sierra Sandison’s decision to wear her diabetes pump on her hip both contributed to and was the result of a trend toward greater acceptance of medical devices and our need for them. (As Miriam Tucker reported at NPR, “Amputees are increasingly using visible prostheses rather than covering them up. And the ostomy community has its own version of the ‘show me’ campaign.”) Nicole Johnson told Tucker that “‘Our culture seems to be more accepting today, as opposed to when I was diagnosed in 1993.'”

Perhaps unsurprisingly, the increase in acceptance has not translated into easy or uniform access to the medical devices that help diabetics manage their disease, including insulin pumps, insulin pens, and continuous glucose monitors. Continue reading

Discrimination on the Basis of Health Status in Health Insurance: “Market-Norm or Necessity”?

By Kate Greenwood
[Cross-posted at Health Reform Watch]

In recent months, advocates have alleged that discrimination on the basis of health status in health insurance continues, notwithstanding the Affordable Care Act’s attempts to level the playing field for people with chronic health conditions. How the government and industry should respond to the allegations is not clear, however, in part because what constitutes “discrimination” is not clear in this context. As Jessica Roberts has noted, there is an “intrinsic tension between an antidiscrimination framework and the practices of the private, for-profit health-insurance industry.” This tension makes it difficult to pinpoint where permissible cost-consciousness ends and impermissible discrimination begins.

As has been widely reported, at the end of May, the National Health Law Program, along with the Tampa-based organization The AIDS Institute, filed an administrative complaint with the United States Department of Health and Human Services’ Office of Civil Rights in which they allege that four qualified health plans offered through the federally-facilitated marketplace in Florida discriminate by “charg[ing] inordinately high co-payments and co-insurance for medications used in the treatment of HIV and AIDS.” The complainants go on to allege that because “[o]ther issuers vary tiering or place HIV drugs on more affordable tiers,” “the practice of placing all anti-retrovirals on the highest tier is not a market-norm or necessity.”

The complaint’s emphasis on whether the plans’ actions reflect a “market-norm or necessity” tracks the Centers for Medicare & Medicaid Services’ 2015 Letter to Issuers in the Federally-Facilitated Marketplaces, in which CMS writes that “to ensure nondiscrimination in [qualified health plan (“QHP”)] benefit design, CMS will perform an outlier analysis on QHP cost sharing (e.g., co-payments and co-insurance) as part of the QHP certification application process.” CMS goes on to specify that, with regard to prescription drugs, a plan will be considered an “outlier” if it has “an unusually large number of drugs subject to prior authorization and/or step therapy requirements in a particular category and class.”

As Sarah Rosenbaum has noted, “CMS does not provide a review methodology or define what is ‘unusually large’.” Even if it had, what if subjecting a large number of drugs to prior authorization or step therapy requirements did not make a plan unusual? Would that mean that doing so was not “discrimination”? Continue reading

Averting Mental Health and Fiscal Crises: Crisis Intervention Teams and Access to Meaningful Treatment for Mental Illness

[Blogger’s Note: I am very pleased to share this post by my colleague at Seton Hall Law, Tara Adams Ragone. This post was cross-posted at Health Reform Watch.]

By Tara Adams Ragone

Social media recently focused my attention on two very different law enforcement interactions with people with mental illness that reinforce the need for increased training of law enforcement in crisis intervention as well as the need for improved access to treatment for people with mental illness.

The first is a video of the fatal police shooting of Kajieme Powell in St. Louis, Missouri earlier this month.  Mr. Powell was twenty-five years old and suspected of shoplifting junk food from a convenience store.  The first eighty seconds of the video show Mr. Powell pacing and muttering on the sidewalk — with four pedestrians passing by without incident — before the police arrive.  The police then exited their vehicles with their guns drawn, shouted at Mr. Powell to drop his weapon, and fired about twelve shots fewer than twenty seconds after they arrived on the scene.

The second is an NPR story that included an audio recording of law enforcement officials in San Antonio, Texas responding to a 911 call about a twenty-four year old group home resident named Mason, who was off of his medications, had set his blanket on fire, and was a danger to himself and others.  When they arrived at the scene, the officers acknowledged that they did not use the “tough guy command voice” that they typically would in responding to a 911 call reporting suspected criminal activity.  Instead, in plain clothes and without their weapons drawn, they spoke calmly with Mason, reassuring him that they wanted to get him help.  They astutely noticed signs suggesting that Mason was experiencing tactile, auditory, and visual hallucinations, and with patience and skilled questioning, got him to acknowledge the hallucinations and seek psychiatric treatment.

The San Antonio officers were members of a six-person mental health squad that the city created to confront severe prison overcrowding. Continue reading

An Autism Diagnosis: Still the Key to Unlocking Needed Services?

By Kate Greenwood

Cross-Posted at Health Reform Watch

In a recent, very moving, post about her son’s diagnosis with autism at age eight, blogger Amy Storch writes: “I guess I should mention the obvious — district services for Autism are much more comprehensive than ADHD.” An autism diagnosis should not, as a matter of law, be the key that unlocks needed special education services. Both autism and ADHD “count” as disabilities under the Individuals with Disabilities Education Act (the relevant regulation is here), and the Act provides that a child with either diagnosis who needs special education services is entitled to an educational program “designed to meet their unique needs.” As a matter of fact, though, an autism diagnosis may mean—as it apparently does in Storch’s school district—a more comprehensive program. An autism diagnosis can also be the key to getting necessary services outside of the school setting, through private health insurance.

According to the advocacy group Autism Speaks, 37 states plus the District of Columbia and the United States Virgin Islands have enacted laws requiring state-regulated private health insurance plans to pay for applied behavior analysis and other therapies children with autism often need. As I blogged about previously here, some of these state insurance mandates are relatively broad—New Jersey’s law requires private insurers to cover applied behavior analysis for children with autism, but also to cover occupational, physical, and speech therapy for individuals with “autism or another developmental disability.” Other states’ mandates, however, are strictly limited to children on the autism spectrum. Daniela Caruso of Boston University School of Law writes about Florida’s decision to limit its insurance mandate to children with autism here, attributing it at least in part to advocates’ success persuading legislators to view autism through a “dual frame of beauty and invasion.”

The Patient Protection and Affordable Care Act’s requirement that individual and small group health insurance plans cover ten essential health benefits, and in particular its requirement that plans cover “rehabilitative and habilitative services and devices,” promised to ease access to applied behavior analysis and other therapies often needed by children by autism. Habilitative care is left undefined in the statute, but it is defined at HealthCare.gov as “[h]ealth care services that help you keep, learn, or improve skills and functioning for daily living,” for example “therapy for a child who isn’t walking or talking at the expected age.”

There is a wrinkle, however. Continue reading

Medicaid ACOs in New Jersey: At the Starting Line at Last

By Kate Greenwood

Cross-Posted at Health Reform Watch

Nearly three years ago, in July of 2011, Tara Adams Ragone wrote a blog post for Seton Hall Law’s Health Reform Watch blog entitled “Community Based Medicaid ACOs in New Jersey: A Signature Away”. As Professor Ragone explained, a month earlier the New Jersey legislature had passed Senate Bill 2443, which established a Medicaid accountable care organization (ACO) demonstration project, but Governor Chris Christie had not yet signed it. “It’s an exciting time for growth and innovation in the Garden State,” Professor Ragone wrote, “if we just get that signature.”

Governor Christie did go on to sign Senate Bill 2443 into law, in August of 2011, but the implementation process has been protracted. The act required the Department of Human Services to “adopt rules and regulations” that provided for oversight of the quality of care delivered to Medicaid recipients in the ACOs’ designated geographic areas and set standards for the gainsharing plans that participating ACOs must develop. The deadline for adopting the regulations was in June of 2012, but they were first issued, in draft form, in May of 2013. The final regulations were not adopted until earlier this week, one day before the proposed regulations were due to expire.

As Andrew Kitchenman reports here, with the regulations in place, the three community-based organizations that have been preparing to launch Medicaid ACOs, one in Camden, one in Trenton, and one in Newark, can finally get started. Unlike the State, they will have to move quickly; the deadline for applying to participate in the three-year demonstration is July 7th.

There is, in Kitchenman’s words, “a final piece to the puzzle”—the participation of managed care organizations (MCOs). Continue reading

Massachusetts’ Ban on “Prescribing and Dispensing” Zohydro: The Arguments For and Against Preemption

By Kate Greenwood

Cross-Posted at Health Reform Watch

As Kurt Karst reported at FDA Law Blog, here, drug maker Zogenix has filed a Motion for Temporary Restraining Order and Preliminary Injunction challenging Massachusetts’ decision to “prohibit the prescribing and dispensing” of the company’s extended-release hydrocodone capsule, Zohydro ER. At a hearing on Tuesday, Judge Rya Zobel told the parties that she is likely to decide in the company’s favor. While Zogenix argues that Massachusetts’ action is unconstitutional for a number of reasons, including that it violates the dormant Commerce Clause and the Contracts Clause, Karst predicts that Judge Zobel will grant Zogenix’ motion on preemption grounds.

Zogenix argues in its Memorandum that “[t]he emergency declaration issued by Governor Patrick, and related order by the Commissioner of the Department of Public Health (DPH), purported to ban Zohydro™ ER based on safety concerns that squarely conflict with – and are therefore preempted by – FDA’s determination that Zohydro ER® is safe and effective and may be marketed and sold in the United States.”  Zogenix notes that the reason Massachusetts gave for banning Zohydro—that the drug lacks abuse-deterrence features—was expressly considered by the Food and Drug Administration during the course of the approval process.  FDA concluded that Zohydro’s benefits, in particular the fact that it contains no acetaminophen, outweighed the risks posed by its lack of such features.

Zogenix acknowledges that the Supreme Court’s decision in Wyeth v. Levine stands for the proposition that when the FDA approves the contents of a drug’s label, the agency merely establishes “a ‘floor’ upon which state tort requirements may build.” But, the company argues, “this is not a labeling case; it is a case about the safety and efficacy vel non of a drug already found to be safe and effective.”  If Massachusetts’ ban is upheld, Zogenix concludes, “Congress’s objectives to promote the public health through FDA drug approvals could be directly contravened by a potential flood of state policy disagreements.”

While Massachusetts has not yet filed papers in opposition to Zogenix motion, there are a number of strong counter arguments it could make. Continue reading

Twitter Round Up

This week’s twitter round up features a variety of topics from our contributors, from discussions about health care spending and the Affordable Care Act to articles about environmental poisoning of soldiers in Iraq.

  • Amitabh Chandra tweeted that “Healthcare spending growth hits a 10yr high… so much for ‘ACA is bending the cost curve’” and shared an article from USA Today.
  • Frank Pasquale shared a blog entry by Larry Backer about Pennsylvania State University students’ worries about the rise of health care costs.
  • I. Glenn Cohen shared a link to an article in The New York Times entitled “‘Environmental Poisoning’ of Iraq Is Claimed” and states that many veterans suffer from environmental poisoning while the “IOM [is] not sure.”
  • Kate Greenwood retweeted Austin Frakt and an article from The Incidental Economist about the negative impact of the insurance market before the implementation of the Affordable Care Act on entrepreneurship.
  • Stephen Latham tweeted a link to his blog reporting on the recent announcement of the Public Health Committee of the Connecticut Legislature that it does not plan to vote on a bill addressing “Aid-In-Dying” or physician-assisted suicide despite “61% public support for the bill.”

Pom Wonderful v. Coca-Cola: Will the Supreme Court’s Decision Have Implications Beyond “Pomegranate Blueberry Flavored Blend of 5 Juices”?

By Kate Greenwood

Cross-Posted at Health Reform Watch

On April 21st, the Supreme Court will hear oral argument in Pom Wonderful v. The Coca-Cola Company, a case in which Pom sued Coke under Section 43(a) of the Lanham Act arguing that Coke’s product “Pomegranate Blueberry Flavored Blend of 5 Juices” was misleadingly named.  Coke countered that the suit should be dismissed because the name was specifically authorized by the Food and Drug Administration’s regulations governing flavored juice blends, and both the District Court and the Ninth Circuit Court of Appeals agreed.

In its opening brief filed last week, Pom argues that neither the provisions of the Food, Drug and Cosmetic Act governing food and beverage labeling generally, nor the regulations that specifically address juice blends, precludes the application of the Lanham Act to Coke’s misleading juice label.  This conclusion, per Pom,

“follows inexorably from this Court’s holding in Wyeth v. Levine … that FDA’s approval of a drug label does not displace state failure-to-warn suits challenging the adequacy of the warning. … Following Wyeth, there can be no serious argument that the provisions of the FDCA are in ‘irreconcilable conflict’ with the Lanham Act.  FDA does not even generally review—much less approve—particular food labels; nothing even arguably prevented Coca-Cola from designing its label to avoid misleading consumers; and FDA has given no indication that its juice-naming rules set the outer bounds of labeling regulation.” 

In its brief opposing Pom’s petition for certiorari, Coke distinguished Wyeth, noting that the provisions of the FDCA governing drug labeling do not expressly preempt state regulation.  The provisions of the FDCA governing food and beverage labels, by contrast, “expressly supplant State laws—including those that imposed more ‘stringent’ requirements[.]”  This, Coke argued, shows that the food and beverage statutory provisions and their implementing regulations “were not intended as a ‘floor’ but rather as the exclusive body of regulation to which food and beverage labels would be subject.”

In her latest article, The Magical Thinking of Food Labeling: The NLEA as a Failed Statute, Diana Winters decries the time and money courts deciding food and beverage labeling cases must spend “negotiating the interaction between federal and state law, with inconsistent outcomes”.  Continue reading

Twitter Round Up

This week’s twitter round up features a variety of topics from our contributors, from discussions about the troubles of patient matching to generic drug labeling and the readmission penalty.

Adrian Gropper shared a link to the most recent entry of his The Health Care Blog entitled “What You Need To Know About Patient Matching and Your Privacy and What You Can Do About It” in which he compares patient matching to “NSA surveillance.”

Amitabh Chandra tweeted that “the current readmission penalty, however well-intentioned, sure looks like a tax on minority and indigent serving hospitals.”

Frank Pasquale shared an article about the myths of high-protein diets and the potential consequences, including the quote that there is a “strong association between longevity and a low-protein, high-carbohydrate diet.”

I. Glenn Cohen shared a link to an article about “Intersextion: Germany Allows Patient to Choose ‘No Sex’ on Birth Certificate” and poses the question of whether or not the United States should follow Germany’s example in making such an allowance.

Kate Greenwood retweeted Alexander Gaffney including a link to a discussion of the new arguments being made about the generic drug labeling rule: “Opponents, Proponents of Generic Drug Labeling Rule Unleash New Argument and Supporters.”

Clinical Trials of Primary Care Drugs: Could Smaller Be Better?

By Kate Greenwood

Cross-Posted at Heath Reform Watch

Lately it seems that each passing day brings another article about the cost of orphan drugs.  Earlier this week at FiercePharma, Tracy Staton reported that the United Kingdom’s National Institute for Health and Clinical Excellence (NICE) has asked Alexion Pharmaceuticals to justify the price of its drug Soliris which is, per Staton, “the most expensive drug in the world” at around $569,000 a year.  Specifically, NICE seeks “‘clarification from the company on aspects of the manufacturing, research and development costs’” of the drug.  According to Staton, this latest development in a review process characterized by “halting progress” is “a departure from NICE’s usual calculations, which typically focus on quality-of-life years and the like.”

Pushback by NICE and other payers notwithstanding, the orphan drug market is growing.  As I blogged about here, in 2013 EvaluatePharma estimated that “the worldwide orphan drug market is set to grow to $127 [billion], a compound annual growth rate of +7.4% per year between 2012 and 2018[,]” which “is double that of the overall prescription drug market, excluding generics, which is set to grow at +3.7% per year.”  In a recent article in the New England Journal of Medicine, venture-capital investors Robert Kocher and Bryan Roberts note that “more than half of the 139 drugs approved by the FDA since 2009 are for orphan diseases” and suggest that there is a risk of “systematically underinvesting in other important areas of medicine.”

Kocher and Roberts’ explain that one reason that orphan drugs attract investment is that their development costs are low.  The problem or potential problem of underinvestment in diseases like depression and diabetes could therefore be addressed, they contend, by bringing the cost of developing treatments for these common conditions in line with the cost of developing treatments for rare diseases.  And, they argue, one promising approach to doing so is to reduce clinical trial costs by reducing the size of clinical trials. Continue reading

Professional Licensing Boards and Antitrust Liability

[Blogger’s Note: I am very pleased to share this post by my colleague at Seton Hall Law, Tara Adams Ragone, in which she discusses North Carolina Board of Dental Examiners v. FTC, drawing on both her scholarly work on the intersection of health care and antitrust law and on her deep experience prosecuting medical licensing actions for the state of New Jersey.]

By Tara Adams Ragone

Cross-Posted at Health Reform Watch

Should state professional boards, which regulate a growing and diverse array of professions and often are composed of professionals from the regulated community, be immune from federal antitrust liability if they engage in anticompetitive conduct?  The Federal Trade Commission thinks not in all cases, the Fourth Circuit agreed, and the North Carolina Board of Dental Examiners has asked the United States Supreme Court to review this decision.

Sasha Volokh recently devoted a 5-part series of blog posts to the major legal issues in play in this case.  He provides an overview of the antitrust state action immunity doctrine here, summarizes the facts underlying the case, North Carolina Board of Dental Examiners v. FTC, here, outlines the differing tests used in the circuits when applying the state action immunity doctrine to professional boards here, offers his opinion on how the Supreme Court ought to resolve these conflicts here (he leans towards the Fourth Circuit’s analysis), and suggests a possible way for the Board to work around the FTC’s injunction (by simply rephrasing its letters to threaten litigation) here.  Sasha’s posts provide an accessible and helpful primer on the case and relevant antitrust case law and are worth a read.

While we wait to learn if the Supreme Court will review this case, Professors Aaron Edlin and Rebecca Haw tackle the question of whether the actions of state professional licensing boards should be subject to antitrust scrutiny in their article, “Cartels by Another Name: Should Licensed Occupations Face Antitrust Scrutiny?” (available on SSRN and forthcoming in the University of Pennsylvania Law Review).  Although they use a question mark in their title, their characterization of licensing boards as cartels is a powerful tipoff to their ultimate conclusion – that licensing boards composed primarily of competitors regulating their own profession should not escape antitrust review: Continue reading

This Oscar Is No Grouch: Can Oscar Health Succeed in Making Health Insurance Fun?

By Kate Greenwood

Cross-Posted at Health Reform Watch

On Wednesday night, I went to a panel presentation sponsored by the group NYC Health Business Leaders on the roll out of New York State’s health insurance exchange.  Among the speakers was Mario Schlosser, the co-founder and co-CEO of the venture-capital-backed start-up health insurance company Oscar Health, which offers a full range of plans through New York’s exchange.  As NPR reportedlast month in a story about Oscar, “it’s been years since a new, for-profit health insurance company launched in the U.S.”, but the Affordable Care Act created a window of opportunity for new entrants.

Schlosser began his talk by giving us a tour of his personal account on Oscar’s website, www.hioscar.com.  Among other things, he showed us the Facebook-like timeline, updated in real time, which tracks his two young children’s many visits to the pediatrician.  He typed “my tummy hurts” into the site’s search engine and the site provided information on what might be wrong and on where he might turn for help, ranging from a pharmacist to a gastroenterologist, with cost estimates for each option.  Additional searches yielded information on covered podiatrists accepting new patients with offices near his apartment and on the out-of-pocket cost of a prescription for diazepam (which was zero, since there is no co-payment for generic drugs for Oscar enrollees).

As an audience member noted, none of this is new exactly.  What is new is to have this kind of data-driven, state-of-the-art user experience being offered by a health insurer.  Schlosser told the audience that Oscar’s pharmacy benefit manager and other vendors are providing the company with real-time data that other insurers have not demanded.  And, according to Schlosser, Oscar’s customers are responding.  Nearly all of them have used the company’s website.  A surprising five percent of them use the company’s website every day. Continue reading

Treating Addiction in Pregnant Women and New Mothers: A Promising Application for Social Impact Financing?

By Kate Greenwood

Cross-Posted at Health Reform Watch 

Last week, vtdigger.org ran an interesting article by Laura Krantz on the difficulties pregnant women and new mothers who are addicted to drugs have accessing not just drug treatment but also all of the other services and supports they need. Krantz reported on a hearing before the Human Services Committee of the Vermont House of Representatives at which a new mother in recovery from addiction, “a neonatalogist, a substance abuse clinician, a Health Department employee and a representative from the Phoenix House, a residential treatment facility in Brattleboro … all said women need not only treatment, but housing, transportation and help finding jobs.”

Alice Larned, a substance abuse clinician at the Lund Family Center in Burlington, told Krantz that spaces in residential detoxification facilities are increasingly scarce. The demand for transitional housing for women who have completed inpatient detoxification also exceeds the supply. Add to this the sad fact that women can wait a year or more for an appointment with a physician who can treat them with methadone or buprenorphine. Larned told Krantz that many of the women who start treatment with her are taking buprenorphine they bought illegally, an “indication they want help ‘yet we don’t have the legitimate means for them to get this medication[.]’”

In another story that ran last week on NPR, Steve Zind spoke with Harry Chen, the Commissioner of the Vermont Department of Public Health, who emphasized the complexities inherent in treating addiction in pregnant women and new mothers. To do so successfully, Commissioner Chen explained, “requires so many different systems working together well: the social service system, the health care system, the substance abuse system and even to some extent the correctional system.”

I confess that one reason that these two articles caught my attention is that Alice Larned is my sister.  Another reason, though, is that the problem described in the articles seems like a promising application for social impact financing, something that has been in the news here in New Jersey in recent weeks.

Continue reading