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This Note proceeds in four parts. Part I briefly looks back at the FDA’s history and the impact of two significant drug crises in establishing the agency’s current framework before explaining the current drug development process. Part II recounts previous challenges to this regulatory framework, which ultimately led to the development of the current expanded access program. Part II also examines the current expanded access program and, more specifically, the evaluation criteria applied by three of its key decisionmakers: the treating physician; the manufacturer; and the FDA.
Part III traces the beginnings of the right to try movement, examining the rationale for the laws and exploring how social media and increased direct-to-consumer advertising of approved drugs possibly created an opening for widespread support of these laws. Part III also explores why the FDA’s efforts to address criticisms of the expanded access program were unable to dissuade enactment of the Right to Try Act. Part IV provides an overview of the Right to Try Act and how the Act differs from expanded access. Part IV further explores why, in general, mainstream industry likely will not adopt the right-to-try pathway, before arguing that pharmaceutical and biotechnology companies should avoid maintaining their current positions regarding pre-approval access, and instead address some of the criticisms raised during the right-to-try movement by (1) revising their existing expanded access policies and (2) improving clinical trial access.
Lawmakers are looking for Affordable Care Act savings in the wrong place. Removing sick people from risk pools or reducing health plan benefits—the focus of lawmakers’ attention—would harm vulnerable populations. Instead, reform should target the $210 billion worth of unnecessary care prescribed by doctors, consented to by patients, and paid for by insurers.
This Article unravels the mystery of why the insurance market has failed to excise this waste on its own. A toxic combination of mismatched legal incentives, market failures, and industry norms means that the insurance market cannot solve the problem absent intervention.
In recent years the False Claims Act (“FCA”) has become the Department of Justice’s (“DOJ”) favorite tool to combat large-scale fraud—particularly healthcare fraud. In fact, from 2009 to 2016 alone, the DOJ recovered over $19.3 billion in health care fraud—“more than half the health care fraud dollars recovered since the 1986 amendments to the False Claims Act.” In general, the statute prohibits (1) knowingly submitting false claims to the federal government or causing another to submit a false claim, (2) knowingly creating a false record or statement to get a false claim paid by the federal government, and (3) retaining funds improperly received from the federal government.
Although the FCA originated during the Civil War, Congress has periodically strengthened the FCA through amendments, which have converted it into a “modern weapon” that the DOJ and whistleblowers use to punish providers who knowingly submit false claims or false records or retain funds improperly received from the government. The amendments have permitted larger damages, which in turn have incentivized whistleblowers and the DOJ to use whatever means available to prove liability in as many false claims as possible. During the last five years in particular, that has meant turning away from proving liability for each individual claim and instead using statistical sampling as proof of liability for a much larger number of claims.
For nearly a decade, health care reform has been at the center of American politics. The development, enactment, and reform of the Patient Protection and Affordable Care Act (PPACA)-“Obamacare,” in the parlance of both opposition and advocates-dominated the election cycles of 2010, 2012, 2014, and 2016, and continued policy changes and market instabilities are all but certain to remain in the spotlight through 2018 and 2020. The endurance of this debate should come as no surprise: national attempts to expand access to affordable medical services have a long history, beginning not with Barack Obama, Mitt Romney, Bill Clinton, or even Lyndon Johnson, but with Teddy Roosevelt and the Progressive Party in 1912. Along the way, while employer-provided insurance came to form the cornerstone of American health care coverage, a wide range of proposals sought to extend benefits to the uninsured, including efforts to create tax subsidies, to introduce single-payer government care, and to impose employer and individual mandates. Of course, it was that final option-the individual mandate, requiring that taxpayers either carry insurance or pay for their failure to do so-that featured in the law finally passed by Congress in 2010. Of “critical importance,” the mandate was “the price for the [insurance] industry’s cooperation.” However, “perhaps because prominent Republicans had [originally] endorsed the idea, Democrats underestimated the problems it would cause.” While the mandate still survives in full through 2018, it will continue only nominally thereafter: shortly before this Note went to press, the narrow Republican majorities in Congress-following years of promises to “repeal and replace” -reduced the mandate’s penalty to $0 for 2019 and beyond, although procedural limitations required them to leave intact the theoretical command.
The mandate has been the subject and survivor of substantial litigation, as well as of considerable scholarship. Underexplored, however, is a provision within the mandate giving special consideration and accommodation to those who obtain membership in a type of medical collective known as a health care sharing ministry: such members are entirely exempt from the PPACA’s requirements. This provision is unique in federal law. Unlike traditional conscientious-objector exemptions (which the PPACA also grants), the sharing ministry exemption demands no showing of a religious burden: to avoid the demands of the individual mandate, one need only join a club structured around shared ethical principles. And as a nation, join we have: sharing ministry membership has expanded dramatically since 2010, so dramatically that the exemption may have helped to accelerate the destabilization of the very risk pools that the Act was meant to supply. But the ability to join is not universal to people of all faiths and creeds, for the exemption contains a cutoff-date clause that not only forecloses the formation of new sharing ministries, but also limits the benefit of an exemption to members of just those sharing ministries which were in operation ten years before the PPACA’s passage. Whether by accident or design, the effect of this limitation is to enshrine in law an accommodation for only five ministries-each one explicitly Christian in its tenets and joining requirements.
The history of the treatment of mental illness in the United States is anything but simple. While both social and scientific understanding of mental illness have developed tremendously in recent decades, there remain significant barriers to implementing effective treatment and rehabilitation programs for people with mental illness. Inherent in this intersection of law and mental health is the delicate balance between preserving liberty and autonomy interests on the one hand, and providing for individual and societal safety on the other. This balance is not easily achieved and remains the core debate surrounding much of today’s mental health legislation.
In March 2014, Gordon Johnston issued an urgent warning to members of Congress: the Food and Drug Administration was “[d]isregarding decades of regulatory stability” by proposing a new regulation that “raises patient safety concerns and threatens the system that created thousands of affordable options for consumers.” Johnston, himself a former deputy director at the FDA, was joined at a press briefing by economist Alex Brill, who estimated that the proposed regulation, if approved, would raise annual U.S. health care costs by $4 billion.
Just what, exactly, was the FDA proposing to do? In the Agency’s words, it sought to “clarify procedures” allowing drug manufacturers “to change . . . product labeling to reflect certain types of newly acquired information.” In plain English, the ultimate consequence of the rule would be explicitly to permit generic drug manufacturers to update their labels with new safety warnings on a temporary basis, pending subsequent agency approval. Under current regulations, brand-name drug manufacturers are already able to update their warning labels in a similar fashion. However, the Agency has taken different positions over the years regarding whether generic drug manufacturers may update their labels. The proposed rule, announced in November 2013, would eliminate the ambiguity by establishing parity between both types of drug manufacturers with respect to label updates.
On September 30, 2012, California became the first state in the nation to place restrictions on the practice of attempting to change an individual’s sexual orientation. The passage of this landmark legislation, known as Senate Bill (“SB”) 1172, set off a firestorm of protest, with multiple lawsuits being filed within twenty-four hours of the bill’s passage. Though the issue of SB 1172’s validity has been decided by the Ninth Circuit, which upheld the law in August 2013, other states are considering passage of similar measures, and many issues were debated minimally or not at all in the California cases. Thus, this Note seeks to examine the potential claims that may be brought on behalf of parents and children against these laws and how such challenges may be overcome. As it is thus far the only law of its kind, SB 1172 is treated as a case study and model in many parts of this Note, and some time is spent discussing the law itself in detail. For the purposes of analysis and simplicity, it is assumed that future laws will be substantively similar to SB 1172.