Tagged: Health Law

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FAN 70.1 (First Amendment News) Amarin v. FDA –Important Commercial Speech Case May be Decided Soon

The FDA has long sought to ban manufacturers from promoting off-label uses of approved drugs and medical devices.  In taking the position that manufacturers and their agents cannot promote off-label uses, the FDA suggests they are safeguarding the public from misbranded medical products and ensuring that manufacturers do not circumvent the drug and device approval processes. Critics, however, have long contended that the FDA’s position violates the First Amendment to the extent it prohibits truthful speech. — Evelien Verpeet, ReedSmith, June 18, 2015

Should pharmaceutical companies be able to advertise drugs for uses not  approved by the FDA? It seems like a no brainer — of course not! But as with so many other things in life and law, the answer (especially the First Amendment answer) is not so obvious.

→ The caseAmarin Pharma, Inc. v. United States Food & Drug Administration (Dist. Ct., S. Dist. NY).

→ Judge: The matter was argued before U.S. District Judge Paul A. Engelmayer on July 7, 2015. A ruling is expected soon.

Unknown5→ Plaintiff’s Claim: “Amarin Pharma wants to provide healthcare professionals with truthful, non-misleading information about its prescription drug Vascepa®, and four doctors who want to receive that information, as they determine when and whether to prescribe that drug. If Amarin provides that information, however, it is at high risk of criminal and civil sanctions being sought against it by the United States.”

U.S. Atty. Preet Bharara

U.S. Atty. Preet Bharara

→ Government’s Claim: “Plaintiffs seek a court order that would allow Amarin to distribute its drug Vascepa under circumstances which could establish that Amarin intends an unapproved new use for Vascepa, i.e., a use for which FDA has not determined that the drug is safe and effective. But Plaintiffs’ legal arguments strike at the very heart of the new drug approval process, and a court decision in Plaintiffs’ favor has the potential to establish precedent that would return the country to the pre-1962 era when companies were not required to prove that their drugs were safe and effective for each of their intended uses.”

The FDA has long banned promotion of drugs for uses other than those it has approved. Yet so-called off-label uses are legal and account for about 20% of all prescriptions. Some off-label uses of drugs have even become the standard of care for particular conditions. But the drug’s manufacturer and its agents—and only them—cannot legally talk about this. Patients can—and do—discuss off-label uses of drugs endlessly in online forums. Doctors certainly exchange information about these uses. — David B. Rivkin Jr. &  Andrew Grossman, WSJ, May 21, 2015

 P’s Counsel: Floyd Abrams is the lead counsel for the Plaintiff with Joel Kurtzberg and Michael B. Weiss (see here re P’s complaint)

→ Gov.’s CounselPreet Bharara is the attorney for the Defendant along with Ellen London and Benjamin Mizer

→ Amicus Briefs: Pharmaceutical Research and Manufacturers of America and Washington Legal Foundation — both in support of the Plaintiff / Public Citizen in support of the United States

→ FDA Letter to Judge Engelmayer, June 8, 2015 (see here for a discussion of the mootness issue raised by this letter)

Excerpts from United States v. Caronia (2nd Cir. 2012) re off-label promotions 

The government’s construction of the FDCA asprohibiting off-label promotion does not, by itself, withstand scrutiny under Central Hudson’s third prong [that the regulation directly advance the government’s interests] . . . . The last prong of Central Hudson requires thegovernment’s regulation to be narrowly drawn to further the interests served. . . Here, the government’s construction of the FDCA to impose a complete and criminal ban on off-label promotion by pharmaceutical manufacturers is more extensive than necessary to achieve the government’s substantial interests. . . . We conclude simply that the government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the lawful, off-label use of an FDA-approved drug. Judge Denny Chin for the majority.

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[T]he majority calls into question the very foundations of our century-old system of drug regulation. I do not believe that the Supreme Court’s precedents compel such a result. . . . If drug manufacturers were allowed to promote FDA-approved drugs for non-approved uses, they would have little incentive to seek FDA approval for those uses. — Judge Debra Ann Livingston dissenting

Summary of Amarin’s First Amendment Arguments Read More

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Prohibitions on Egg and Sperm Donor Anonymity and the Impact on Surrogacy

Egg and sperm donations are an integral part of the infertility industry. The donors are usually young men and women who donate relying on the promise of anonymity. This is the norm in the United States. But, internationally things are changing. A growing number of countries have prohibited egg and sperm donor anonymity. This usually means that when the child who was conceived by egg or sperm donation reaches the age of eighteen he can receive the identifying information of the donor and meet his genetic parent.

An expanding movement of commentators is advocating a shift in the United States to an open identity model, which will prohibit anonymity. In fact, last year, Washington state adopted the first modified open identity statute in the United States. Faced by calls for the removal of anonymity, an obvious cause for concern is how would prohibitions on anonymity affect people’s willingness to donate egg and sperm. Supporters of prohibitions on anonymity argue that they only cause short-term shortages in egg and sperm supplies. However, in a study I published in 2010, I showed that unfortunately that does not seem to be the case. My study examined three jurisdictions, which prohibited donor gamete anonymity: Sweden, Victoria (an Australian state) and the United Kingdom. It showed that all these jurisdictions share dire shortages in donor gametes accompanied by long wait-lists. The study concluded that although prohibitions on anonymity were not the sole cause of the shortages, these prohibitions definitely played a role in their creation.

In a new article, titled “Unintended Consequences: Prohibitions on Gamete Donor Anonymity and the Fragile Practice of Surrogacy,” I examine the potential effect of the adoption of prohibitions on anonymity in the United States on the practice of surrogacy. Surrogacy has not been part of the international debate on donor gamete anonymity. But the situation in the United States is different. Unlike most foreign jurisdictions that adopted prohibitions on anonymity, the practice of surrogacy in the United States is particularly reliant on donor eggs because of the unique legal regime governing surrogacy here.  Generally, there are two types of surrogacy arrangements: traditional surrogacy and gestational surrogacy. In a traditional surrogacy arrangement the surrogate’s eggs are used and she is the genetic mother of the child, while in gestational surrogacy the intended mother’s eggs or a donor’s eggs are used and the surrogate is not the genetic mother of the conceived child. Most U.S. states that expressly allow surrogacy provide legal certainty only to gestational surrogacy, which relies heavily on donor eggs, while leaving traditional surrogacy in a legal limbo. Without legal certainty, the intended parents may not be the legal parents of the conceived child, and instead the surrogate and even her husband may become the legal parents. Infertility practitioners endorse the legal preference for gestational surrogacy also for psychological reasons, believing that a surrogate who is not genetically related to the baby is less likely to change her mind and refuse to hand over the baby.

The adoption of prohibitions on anonymity in the United States could destabilize the practice of surrogacy in a way that did not occur in other countries that adopted these prohibitions. If, as has happened elsewhere, prohibitions on anonymity will play a role in creating shortages in donor egg supplies in the United States, this could affect the practice of surrogacy in two ways. Individuals seeking surrogacy may need to resort to traditional surrogacy, which does not rely on donor eggs, with the accompanying legal uncertainty. Alternatively, those deterred by the uncertainty enveloping traditional surrogacy may refrain from seeking surrogacy altogether, resulting in a significant contraction of  the practice of surrogacy in the United States. These potential complications suggest that those supporting the adoption of prohibitions on anonymity in the United States, should consider these changes with great caution and think beyond the traditional debate about the privacy of the donors, the privacy and procreational interests of the intended parents, the best interests of the children and the direct effect on gamete supplies.

 

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Waldo’s Optimal Fragmentation

Thank you Frank, Glenn, and Concurring Opinions for inviting me to participate in the online Fragmentation book review symposium.  As serendipity would have it, your timing could not have been better, for two reasons.

First, just last week in my Health Care Finance class here at the University of Georgia, we began the chapter on “The Structure of the Health Care Enterprise,” which opens, as those familiar with the Furrow, Greaney, et al. Health Law casebook know, with a classic fragmentation scenario:  Our 35-year-old patient, Waldo, a recurring character throughout the casebook, must navigate the late 1970s health care system and all of its poorly coordinated care, minimal attention to quality, self-interested referrals, fee-for-service payment, and balance-billing flaws.  Students are urged to observe the deficiencies and incentives driving the U.S. health care “system” — or lack thereof — and prepare, in future chapters, to compare Waldo’s treatment under, first, 1980s managed care and, later, contemporary consumer-driven health care.  Preparing for this Symposium primed me for discussing the Waldo example with my students.

Second, over the weekend I presented at the Midwestern Law and Economics Association conference, where I had the good fortune to see my friend and mentor, David Hyman.  Thanks again to the upcoming Symposium, I had just read David’s chapter on my flight to Denver and could engage his thoughts on the Fragmentation book.  As I commented to David, what I find so refreshing and valuable about this book is that it does not start from the well-worn and, to me, uninteresting, suggestion made whenever one is asked to talk about what’s wrong with the United States health care system:  “Well, really, don’t we just need universal health care, a single-payor system?  If Canada can do it, why can’t we?”  (I mean no disparagement to Vickie Williams’s excellent post earlier today on this point, for those who are less jaded than I.)  Instead, the book accepts the system we have — an admittedly disjointed amalgam of government programs and regulations, along with competitive markets and incentives — and asks how it might be improved.

David’s chapter focuses on payment systems as a source of fragmentation and provides some nice examples even within particular health care programs or payors.  For example, Medicare A (hospitalization) providers have no incentive to consider Part B (outpatient and physician services) providers’ costs because the Parts operates as “payment silos,” under distinct reimbursement methodologies, with no need to coordinate care or service delivery.  With dually eligible beneficiaries, the fragmentation is even worse:  Medicare faces higher costs if poor quality care in Medicaid-covered long-term care settings precipitates an acute hospitalization, while Medicaid faces higher long-term care costs if Medicare prescription drug coverage fails to treat beneficiaries’ chronic conditions.  The chapter suggests some payment reform strategies, such as medical homes, pay-for-performance, and bundled payments, which have been debated and adopted to varying degrees by government and private payors, including in the recent Patient Protection and Affordable Care Act.

The end of the chapter was the most provocative.  In David’s characteristically contrarian, and, to me, always entertaining way, he concludes by begging the question:   Before we get all worked up about fragmentation and how to fix it, we should step back and consider that, at least in some cases, we seem to (and, he would suggest, at least sometimes, should) prefer fragmented health care delivery.  He points to the popularity of Wal-Mart retail clinics, medical tourism, and specialty hospitals.  And I would add the decline of managed care, rise of concierge medicine, and popularity of $4 prescription drugs.  Of course, as David acknowledges, those trends reveal other, deeper flaws in our health care delivery “system.”  But before jumping on the de-fragmentation bandwagon, Waldos should consider carefully what they may have to give up.

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Integrated Delivery Systems as a Panacea

In “Curing Fragmentation with Integrated Delivery Systems,” Alain Enthoven, the father of “managed competition,” extols his creation as a cure for what ails America’s fragmented health system.  Indeed, many of Enthoven’s proposals for reducing fragmentation in our health care system, such as regional health insurance exchanges, were incorporated into the Patient Protection and Affordable Care Act (“PPACA”), the health care reform bill signed into law on March 23, 2010.

Although a proliferation of integrated delivery systems competing with each other for business may be a step in the right direction, it will do little or nothing to cut down on the enourmous amount of health care resources spent on compliance with ever-expanding numbers of billing rules.  Even Professor Enthoven acknowledges that a single-payer system could solve many of the same problems as his integrated delivery system proposal, but he believes that Americans do not have the political will to accept such a system.  Professor Enthoven also fails to consider that even less-radical changes to our health care system, such as adopting a system of encrypted medical records that a patient carries with her, like the French “carte vitale,” would greatly cut down on or eliminate poor medical outcomes that are attributable to fragmentation in the system.

A well-managed single-payer system could  satisfy the American appetite for market competition, and achieve more than the integrated delivery systems proposed by Professor Enthoven.  Competition could still take place at the insurer level, much like in Germany, or it could take place amongst providers, such as in Japan (whose system author T.R. Reid cleverly describes as “Bismarck on Rice” in his recent book The Healing of America (Penguin Press 2009)).

Professor Enthoven’s example of the “epitome of integrated delivery system[s]” is Kaiser Permanente (for which Enthoven is also a consultant, according to his Stanford University on-line biography).  His vision is for the American people to have a choice of many Kaiser Permanente-like organizations.  This presumes that people want choices when it comes to picking a health plan, a presumption shared by PPACA.  I believe that is incorrect.  What people want is choice of providers.  Nobody loves their payers; they love their doctors.  They want to make sure they don’t receive numerous bills for every little service they receive, but they don’t really care about who pays those bills.  Only the ultimate integrated delivery system, a single-payer one with a compensation system based on outcomes, not services, will achieve this.

It is true that many of the single-payer systems in use around the world are underfunded and under inflationary pressure.  A single-payer system in the United States would be no exception.  Despite our current economic woes, we remain the richest country in the world.  As Dr. Marcia Angell, former editor-in-chief of the New England Journal of Medicine stated in the 2000 PBS documentary “Healthcare Crisis:  Who’s at Risk?,” the amount of our GDP that we spend on health care is not really important.  What is important is that we get good outcomes and the customer satisfaction that we are paying for.  Managed competition and “integrated delivery systems” although a step in the right direction, will not solve our problems in the long run.