The pharmaceutical industry is a competitive business. Companies spend billions of dollars researching and developing new drugs. Many drugs never make it to market. For the limited drugs that make it through the experimental, regulatory, and clinical rigors of drug development, companies recoup their lost expenditures for the drugs that previously failed.

Pharmaceutical companies face increasing pressure to bring new treatments to market in order to survive. The economic reality of survival and profits may distort a company's decision-making process regarding full disclosure on a particular new drug. An example of this type of conflict was seen in the silicone breast implant fiasco in the 1970s, 1980s, and 1990s. Dow Corning, the manufacturer of the implants, withheld important data from long-term animal models that demonstrated adverse effects from the breast implants. Further, Dow failed to conduct long-term studies on breast implants, even when armed with data indicating that such studies were necessary to ensure the continued health of the patients.

In this Article, I advance a new frame through which to organize discourse on disability and the law: the notion of ambivalence. I make two claims, one descriptive and one normative. Descriptively, I argue that ambivalence pervades encounters with disability. Disability attracts because it is a force that makes us human and disability repels because it is a force that threatens our humanity. The tension between these sentiments is not easily tolerated and tends to prompt denials of ambivalence; we embrace a conscious view of disability that belies our mixed sentiments and we suppress reactions to disability that conflict with this conscious view. Normatively, I argue that the law should express and expose ambivalence about disability. When we deny ambivalence, I argue, we cannot account for our genuine sentiments and we cannot prevent suppressed sentiments from emerging, intensified, in harmful and unanticipated forms. To avoid these dangers, the law should prevent the embrace of unequivocal views of disability as valued, devalued, or neutral, and seek to expose ambivalence about disability to the public. This prescription calls into question the prevailing orthodoxies of disability law.

The healthcare system is sick. The players are incentivized to maximize their own benefit and externalize their costs onto the other parties. This paper examines the warped incentives that underlie the system. The tort system, lacking expertise and slow to adapt, is unable to overcome cognitive biases to adequately solve the problems. Clinical practice guidelines could pose a solution, but not as they are currently developed. Guidelines promulgated by healthcare associations are infected by a web of conflicts of interest with every player in the industry. Government agencies, and their revolving doors, are underfunded and also subject to the industry's web of conflicts. Even if adequate guidelines could consistently be produced, state legislatures and courts have been unwilling and unable to substantially incorporate guidelines into the legal landscape. Lastly, this article proposes a private regulation regime that could be a solution which would align all of the players' incentives to society's interests.

The role of Medicare in our national market for acute care hospital services is that of a power buyer. Medicare beneficiaries in 2008 included some 45.2 million people. Total benefits paid in 2008 were $462 billion, including 29% of all hospital spending. Medicare's dominance in the buyer's market for acute care hospital beds renders the program particularly wellsuited to scrutinize the role of acute care hospital services in producing effective and efficient outcomes for Medicare beneficiaries. “[I]f there are to be far-reaching changes in the way medicine is practiced in this country, Medicare will have to drive them.” It is a historical irony that a program, a scaled-down version of national health insurance, could have grown to this power buyer status; but the history of Medicare is full of ironies—the greatest of which may prove to be that Medicare reforms now sit at the very center of the funding mechanisms for the 2010 Patient Protection and Affordable Care Act (PPACA).

The Patient Protection and Affordable Care Act (PPACA), as amended by the Health Care and Education Reconciliation Act of 2010, initiated comprehensive health reform for the healthcare sector of the United States. PPACA includes strategies to make the American healthcare sector more efficient and effective. PPACA's comparative effectiveness research initiative and the establishment of the Patient-Centered Outcomes Research Institute are major strategies in this regard. PPACA's comparative effectiveness research initiative is one in a long line of federal initiatives to address the rising costs of healthcare as well as to obtain better value for healthcare expenditures. The key question is whether the governance and design features of the institute that will oversee the initiative will enable it to succeed where other federal efforts have faltered. This Article analyzes the federal government's quest to ensure value for money expended in publically funded healthcare programs and the health sector generally. This Article will also analyze what factors contribute to the possible success or failure of the comparative effectiveness research initiative. Success can be defined as the use of the findings of comparative effectiveness to make medical practice less costly, more efficient and effective, and ultimately, to bend the cost curve.

Off-label promotion of prescription drugs has become a source of substantial controversy in the past decade. Before a new drug reaches the market, its safety and efficacy must be certified by the Food and Drug Administration (FDA). But the FDA does not simply approve a drug for general use. Rather, it approves drugs for the specific uses requested by manufacturers, who choose the universe of possible indications when they undertake pre-marketing clinical trials. The approval is therefore tied to a particular disease that is the subject of the manufacturer's pre-approval testing and the FDA's formal review. The conditions for which the product is approved are spelled out in the official drug label, including the dose evaluated by the FDA, and the details of administration in which the FDA has determined the drug showed efficacy. The label also describes the safety concerns related to the use.

This article provides an overview of how the constitutional protections for commercial speech affect the Food and Drug Administration's (FDA) regulation of drugs, and the emerging issues about the scope of these protections. A federal district court has already found that commercial speech allows manufacturers to distribute reprints of medical articles about a new off-label use of a drug as long as it contains disclosures to prevent deception and to inform readers about the lack of FDA review. This paper summarizes the current agency guidance that accepts the manufacturer's distribution of reprints with disclosures.

Allergan, the maker of Botox, recently maintained in a lawsuit that the First Amendment permits drug companies to provide “truthful information” to doctors about “widely accepted” off-label uses of a drug. While the case was settled as part of a fraud and abuse case on other grounds, extending constitutional protections generally to “widely accepted” uses is not warranted, especially if it covers the use of a drug for a new purpose that needs more proof of efficacy, and that can involve substantial risks.

A health law academic pointed out in an article examining a fraud and abuse case that off-label use of drugs is common, and that practitioners may lack adequate dosage information about the off-label uses. Drug companies may obtain approval of a drug for a narrow use, such as for a specific type of pain, but practitioners use the drug for similar uses based on their experience. The writer maintained that a controlled study may not be necessary to establish efficacy for an expanded use of a drug for pain. Even if this is the case, as discussed below in this paper, added safety risks may exist if the expansion covers a longer period of time and use by a wider number of patients. The protections for commercial speech should not be extended to allow manufacturers to distribute information about practitioner use with a disclosure about the lack of FDA approval. Distributions of information about unapproved uses should not be acceptable unless experts consider the expanded use to be generally recognized as safe and effective based on adequate studies.

The last part of this paper considers the need to develop better research incentives to encourage more testing and post-market risk surveillance by drug makers on off-label uses of their drugs. Violations of the Federal Food Drug and Cosmetic Act (FFDCA) can be considered violations of the False Claims Act, which opens the way to fraud and abuse suits. The scale of penalties involved in these suits may lead to more examination of the scope of FDA regulation and commercial speech protections. Thus this symposium's consideration of these issues is timely and important.

Children with significant disabilities may qualify for Medicaid benefits, regardless of household income, if their state elects to offer the Tax Equity Fiscal Responsibility Act (TEFRA) option. However, a significant number of children with serious medical problems presently are being denied eligibility for, or terminated from, this Medicaid program. This Article describes the ways in which the existing health insurance system inadequately meets the needs of children with significant disabilities, recounts the history and development of the TEFRA Medicaid coverage option, and analyzes the eligibility criteria used by the various states. It proceeds to consider how disability should be legally defined in the health care context and proposes reforms to modernize the eligibility standards so that these benefits can be more effectively, efficiently, and fairly allocated. To accomplish this goal, the federal statute and regulation that define disability, as well as corresponding state laws, must be reformed so that the law can keep pace with advances in modern medical science, and people with disabilities are not, in effect, penalized for receiving currently accepted preventative care that maintains health but will never cure the underlying disease.

In this Article, I describe and examine the severe shortcomings in women's autonomy in the context of reproductive choices in the medical arena. The reproductive choices I explore are those choices that involve gestation: abortion, fertility treatments, and interventions during pregnancy. Due to state and medical interests in the fetus, I describe how information conveyed to patients making reproductive choices is biased towards fetal interests, relies on female stereotypes, and is still conveyed with the objective authority of the medical profession. Moreover, reproductive choices implicate women's values and identity interests that reach beyond medical concerns, which are not part of the informed consent doctrine at all. The narrow, individualistic informed consent torts doctrine intended to protect patient autonomy does not do enough in this context to balance bias nor does it mandate discussion of important identity interests and values. Accordingly, I argue that when faced with reproductive choices, women are not provided the balanced and comprehensive information needed to promote their autonomy.

In response to the breakdown in patient autonomy I describe, instead of leaving women alone to make choices or regulating in order to protect them from their choices, a broader framework for supporting reproductive choices should be established. In light of the interdependence of woman and fetus, as well as the broader social context shaping these decisions, I argue that a more contextual, relational perspective of autonomy should be the goal of informed consent in the context of reproductive choices. I suggest a number of reforms that aim to optimize patient autonomy from a relational perspective. I suggest a broad, deliberative doctor-patient consultation and legal reforms that create more balance between the pull towards intervention and fetal protection on the one hand, and non-intervention and protection of women's personal identity interests on the other.

Critics of the Food & Drug Administration's ban on off-label promotion often claim that it violates the First Amendment because it suppresses pharmaceutical manufacturers' truthful speech about their legal—and beneficial—products. Characterizing the ban on off-label promotion in this way has more than rhetorical significance. Bans on truthful, non-misleading speech elicit special skepticism because of the belief that they “usually rest solely on the offensive assumption that the public will respond ‘irrationally’ to the truth.” The legislative history of the provisions of the Food Drug and Cosmetic Act that underlie the ban on off-label promotion, however, reveals that Congress was concerned that physicians were responding rationally to false and misleading promotional claims. In this Article, I explore the doctrinal questions raised by conceiving of the ban on off-label promotion not as a ban on “truthful speech to physicians” but instead as a prophylaxis against false and misleading pharmaceutical promotion. I review the evidence that false and misleading claims were commonplace before the ban's adoption and persist today, along with the enforcement challenges the FDA confronted at that time and would confront were the ban lifted, and conclude the government likely could develop the factual record necessary to establish that Congress' rejection of an after-the-fact case-by-case approach to combating false and misleading prescription drug promotion is constitutional.

Arguably the most controversial change to the U.S. healthcare system written into the Patient Protection and Affordable Care Act (“PPACA” or the “Act”) is what has been colorfully termed the Act’s “individual mandate,” the provision that establishes tax penalties for those who do not maintain health insurance in 2014 and beyond. Though the health insurance mandate does not go into effect until 2014, it has already faced numerous constitutional challenges in district and circuit courts, with entirely inconsistent results. Conflicting decisions regarding the Act’s constitutionality at the circuit court level cry out for Supreme Court review. But while the individual mandate’s validity under either the Commerce Clause or Congress’s taxing power has been the focal point of litigation thus far, another aspect of the individual mandate may undermine the goal of establishing universal, affordable healthcare coverage for all Americans. As currently written, the religious conscience exemption from the PPACA’s individual mandate threatens the efficacy of the Act and potentially exposes it to legal challenges under the Constitution’s Religion Clauses.

Imagine the following scenario:

Biologics include a wide range of products, such as vaccines, allergenics, gene therapies, and tissues, among others. Biologics are complex combinations of sugars, proteins, or nucleic acids that are produced by biotechnology methods or other advanced technology. Biologics often represent the only medical treatment for complex medical conditions such as: Hepatitis B; Measles, Mumps, Rubella and Varicella; and Tetravalent meningococcal conjugate among others. As a result, biologic sales are growing at twice the rate of chemical pharmaceuticals and are expected to exceed $158 billion by 2015. Various interest groups, including patients, insurers, and regulatory agencies, raised concerns about the financial impact that biologics may have on health care costs. Congress and the Food and Drug Administration (FDA) faced pressure to provide a solution to the soaring biologic costs, namely through a regulatory pathway for generic biologics (“follow-on biologics”) to manufacture cheaper products. Although a regulatory pathway for generic chemical pharmaceuticals (“generic”) exists under the Hatch-Waxman Act, a similar regulatory pathway for follow-on biologics did not exist prior to 2010.

Historically, government has been given more leeway when invoking its interests in safeguarding the public health than when asserting other state interests. Thus, for example, when considering a constitutional challenge to mandatory smallpox immunization in Jacobson v. Massachusetts, the Supreme Court employed its highly deferential, rational basis review rather than the stricter level of scrutiny that it normally employs when individuals assert interests in bodily integrity. Similarly, Congress and the Food and Drug Administration (FDA) have imposed greater restrictions on the speech of pharmaceutical companies than have been considered acceptable for speech in other commercial settings.

In recent years, however, it appears that a trend is developing toward applying the same level of constitutional scrutiny to health regulation. In Abigail Alliance, a three-judge panel in the U.S. Court of Appeals for the D.C. Circuit overrode FDA regulations to recognize a constitutional right of access for patients to experimental chemotherapy.

Victoria, a pregnant inmate housed in a Louisiana state prison, brought a civil rights action challenging the prison’s policy of requiring her to obtain a court order to receive an elective abortion. Although Louisiana state law purported to allow Victoria to obtain an elective abortion, Victoria was unable to obtain her abortion because of procedural delays. Victoria was released from prison before she gave birth but her pregnancy was too far along for her to legally obtain an abortion. She was therefore forced to carry her pregnancy to term and forced to place her newborn child with adoptive parents. Had she given birth in prison, she would have been shackled to her hospital bed, as Louisiana policies require.

Little information regarding pregnancy, prenatal care, perinatal outcomes, and access to elective abortions for female inmates exists. We know, however, that between six and ten percent of the women entering jail or prison are pregnant and that more women may become impregnated in prison as a result of rape by prison guards.

In order to protect the nation from harmful or worthless drugs and devices, the Food and Drug Administration (FDA or the Agency) is legislatively authorized to restrict the sale of prescription drugs or medical devices to those whose efficacy and safety have been reviewed and approved by the Agency. Drugs and devices are approved for a specific medical purpose. In numerous instances, however, the medical profession has discovered that treatments approved for one purpose may also serve other valuable medical purposes. Indeed, on a number of occasions such “off-label” treatments have proven to be essential to the successful treatment of some very serious illnesses.

In these off-label situations, the FDA is faced with a dilemma. On the one hand, off-label use of prescription drug and devices gives rise to a series of major problems for the FDA. While the drug and devices in question have been vetted and approved by the FDA for their designated purpose, at no point has the FDA reviewed the supporting scientific data to determine efficacy for the off-label purpose.