Comparative drug policy analysis (CPA) is alive and well, and the emergence of robust alternatives to strict prohibition provides exciting research opportunities. As a multidisciplinary practice, however, CPA faces several methodological challenges. This commentary builds on a recent review of CPA by Ritter and colleagues to argue that the practice is hampered by a hazy definition of policy that leads to confusion in the specification and measurement of the phenomena being studied. This problem is aided and abetted by the all-too-common omission of theory from the conceptualization and presentation of research. Drawing on experience from the field of public health law research, this commentary suggests a distinction between empirical and non-empirical CPA, a simple taxonomic model of CPA policy-making, mapping, implementation and evaluation studies, a narrower definition of and rationale for “policy” research, a clear standard for measuring policy, and an expedient approach (and renewed commitment) to using theory explicitly in a multi-disciplinary practice. Strengthening CPA is crucial for the practice to have the impact on policy that good research can.
Theory and Methods in Comparative Drug Policy Research: Response to a Review of the Literature by Scott Burris :: SSRNJanuary 21, 2017
This study examines the patterns and causes of shortages in generic non-injectable drugs (e.g., tablets and topicals) in the United States. While shortages for injectable drugs have garnered more attention, shortages of other forms of prescription drugs have also been on the increase. In fact, they follow a strikingly similar trend with a number of important tablet drugs having recently been affected by shortage. This poses important questions about the root causes of these trends since most explanations found in the literature are specific to generic injectable drugs. Using a simple heuristic framework, three contributing factors are explored: regulatory oversight, potential market failures in pricing/reimbursement, and competition. This paper features an empirical examination of the contribution of changes in regulatory oversight to drug shortages. A pooled dynamic regression model using FDA data on inspections and citations reveals a statistically significant relationship between FDA regulatory activity (inspections and citations) and drug shortage rates. This result cuts across both injectable and non-injectable drugs, and could reveal a transition in equilibrium quality that should be transitory in nature, but it should also be interpreted with care given the other factors likely affecting shortage rates.
Drug prices are in the news. “Pharma Bro” Martin Shkreli increased the price of Daraprim, a treatment for fatal parasitic infections, by 5000%. Mylan found itself on the hot seat for raising the price of the anaphylaxis-treating EpiPen 15 times in 7 years, resulting in a 400% increase to more than $600. Politicians rail about the harms of high drug prices.
What can the next Administration do? A lot. This article shows how — even without directly regulating price — it can use antitrust law to reduce prices by challenging an array of anticompetitive behavior. It can target settlements by which brand drug firms pay generics to delay entering the market. It can go after “product hopping,” by which a brand firm switches from one version of a drug to another to forestall generic competition. It can target distribution restrictions that brands have instituted to block generics. And it can challenge other conduct in the industry. In short, antitrust law has a vital role to play.
Antitrust is about competition, which lowers prices and increases choice. Consumers in the pharmaceutical industry suffer harms as directly in this setting as anywhere. High drug prices have resulted in patients not being able to take vital medicines or splitting pills in half. To add insult to injury, this anticompetitive behavior typically is not justified based on innovation or patents. The agencies in the next Administration have important tasks ahead of them in targeting conduct in the pharmaceutical industry.
The Scope of Preemption under the 2009 Family Smoking Prevention and Tobacco Control Act by Sam Halabi :: SSRNDecember 14, 2016
The 2009 Family Smoking Prevention and Tobacco Control Act endeavored to alter the regulatory regime for tobacco products in the United States by allocating authority to regulate tobacco products to the U.S. Food and Drug Administration (FDA). While the law aims at greater transparency in the constituent components of cigarettes and non-combustible tobacco products, it also includes a provision which will bring FDA’s consumer protection and tobacco control mandates into tension: Section 911’s process for the approval of modified risk tobacco products. That provision allows tobacco manufacturers to submit applications to label products as “reduc[ing] the harm or the risk of tobacco-related disease associated with commercially marketed tobacco products.” As public health researchers have noted, Section 911 threatens to codify and authorize long-standing industry practices of asserting or implying health-promotion or harm-limiting claims that are in fact intended and shown to have precisely the opposite outcome including most recently the use of descriptors like “mild”, “light”, “ultra-light” and “low.” In 2014, FDA opened a comment period for the first modified risk tobacco product produced by Swedish Match as part of a joint venture with Philip Morris. One of the most effective ways of policing industry use of modified-risk tobacco labeling is product liability claims based on state common law torts. Section 916 of the Tobacco Control Act provides an ambiguously phrased preemption provision which will implicate the reach of Article VI preemption for FDA-approved products. This article is the first to analyze the heretofore unanswered question: what is the scope of constitutional preemption when Section 911 (modified risk tobacco products) and Section 916 (preemption of state law) are read together against the broader background of U.S. Supreme Court precedent that will shape that inquiry? Tobacco consumers will inevitably use state law causes of action to allege that the content of tobacco manufacturers’ modified risk claims are misleading, that modified risk claims extend use of non-modified risk claim products, and that modified risk tobacco products are used to shape risk perception across other product lines. At stake in answering the preemption question correctly is how the tobacco industry may use Section 911 to continue historical practices with FDA’s approval and the public health implications of doing so as well as the broader relationship between the 2009 Act and state law as FDA and federal courts shape the law’s implementation.
Clinical Trials for New Drug Development: Optimal Investment and Application by Panos Kouvelis, Joseph Milner, Zhili Tian :: SSRNDecember 10, 2016
Phase III clinical trials are expensive, require enrolling and treating hundreds or thousands of patients at many sites. The time and cost required to do so is uncertain as is the economic value of the drug upon completion. We consider the problem of determining when and how many test sites should be opened, and the rate patients should be recruited. We model the problem as a discrete-time, discounted dynamic program with the objective of maximizing the expected net present value of a drug based on the costs of conducting the trial, and on the drug’s quality-moderated likelihood of approval and its subsequent expected revenue stream if approved. We show the optimal policy is characterized by a series of thresholds on the number of patients enrolled over time that indicate when additional test centers should be opened and how many patients should be targeted. We demonstrate using data from completed clinical trials that for lowto-moderate valued drugs, these thresholds are relevant to the firm’s decisions. We extend the problem to the case with multiple interim analyses and demonstrate that optimizing the clinical trial capacity and its utilization provides significant value in addition to the option value of stopping the trial early.
There is growing interest in states regulating pharmaceuticals in ways that challenge the U.S. Food and Drug Administration’s (FDA) federal oversight. For example, in 2013 Maine enacted a law to permit the importation of unapproved drugs, reflecting concerns that federal requirements are too restrictive, while in 2014 Massachusetts banned an FDA-approved painkiller, reflecting concerns that federal requirements are too lax. This Article provides an account of this recent state interest in regulating drugs and considers its consequences. It argues that these state regulatory efforts, and the nascent litigation about them, demonstrate that the preemptive reach of the FDA’s authority extends into medical practice regulation in some circumstances. It then begins to explore implications outside of the preemption context, arguing that state regulatory efforts may also help to inform our general understanding of both the scope of the FDA’s jurisdiction and the relationship between the FDA and the states.
Not Quite the Same: Regulatory Intermediaries in the Governance of Pharmaceuticals and Medical Devices by Martino Maggetti, Christian Ewert, Philipp Trein :: SSRNDecember 5, 2016
This article compares the role of regulatory intermediaries in the governance of pharmaceuticals and medical devices in Australia and Switzerland. We argue that the creation, selection, and activation of specific intermediaries depend on the organizational capacity of the regulator and on the capture potential of the target. To limit the risk of capture of intermediaries where the regulated industries are powerful, regulators tend to keep intermediaries under their control. To do so, the regulator must be well-funded and well-staffed, or supported by its political principal. However, when the target has limited capture potential, regulators will rely more heavily on externalized intermediaries. These intermediaries typically consist of transnational organizations in charge of multiple regulatory issues in several jurisdictions, and can provide unique expertise in an efficient way. Four case studies of the Australian and Swiss regulatory regimes for therapeutic products support this argument.