Here’s a round up of FDA-law related readings posted to SSRN in August.
This excludes articles that were published before 2017 but posted on SSRN for the first time in August 2017. It also omits pieces for which the abstract, but not the article, was posted. As a result, for instance and unfortunately, it does not include Professor Jordan Paradise’s new piece, Regulatory Silence at the FDA: Impact on Drug and Biologic Competition. The abstract indicates she explores the agency’s “reluctance” to wade into issues relating to patent law as well as the contribution of this “silence” to anti-competitive action that harms consumers.
Joseph Lawless, Sex, Drugs, and Commercial Speech: The Contested Discourse of Truvada (forthcoming in the Columbia Journal of Law and Social Problems). Mr. Lawless graduated from Columbia Law School in 2017 and is a PhD candidate (American Studies) at William & Mary. This Comment focuses on a letter to FDA arguing that Gilead’s advertising of Truvada misleads viewers into believing the drug is safe and effective for situational use rather than for preexposure prophylaxis to reduce the risk of HIV infection. He situates the letter within the commercial speech cases relating to FDA regulation of “off label” speech, suggests that the agency is actually “hardening” its stance towards off-label speech (for instance through its new intended use regulation), and suggests that pursuing Gilead would amount to attacking a company that is providing medically important information to a community otherwise imperiled by lack of access to medical information and drugs.
On a related note, FDA has opened several dockets in the last year relating to communications about medical products, including this docket for comments on its January 19 memorandum discussing communications about unapproved uses. Most of the patient groups and consumers commenting in the docket seem to have opposed loosening restrictions on discussion of off label use (e.g., comments from the USA Patient Network) but at least some (such as NORD, in collaboration with other groups) have argued that current restrictions may limit the ability of some patients to learn about vital therapies.
Eileen M. Kane, Human Genome Editing: An Evolving Regulatory Climate (forthcoming in Jurimetrics). This paper appears in a symposium issue arising out of a conference on “Governance of Emerging Technologies: Law, Policy, and Ethics” at the Sandra Day O’Connor College of Law (Arizona State University) in May 2016. Professor Kane (Penn State Law) describes the history of human genetic modification technologies, starting with the first experiments to produce recombinant DNA in the 1970s, the establishment of the Recombinant DNA Advisory Committee (RAC) at NIH in 1974, and the Asilomar Conference in 1975, in the early years, all the way through to the recently developed CRISPR-Cas9 system for genome editing. Section III discusses “oversight of genome editing in the human germline” and helpfully canvasses both domestic and non-U.S. governmental oversight as well as formal and informal reactions/oversight within the scientific community. The concluding pages offer thoughts about the future, including about the prospect of human germline genetic modification (which seems unlikely to be permitted, at least for now). Professor Kane has a blog on law, policy, and biotechnology, here.
Jordan Paradise, Crowdsourcing Genomics: Exploring PrecisionFDA (working draft). In this brief but very detailed paper, Professor Paradise (Loyola University Chicago School of Law) discusses FDA’s efforts to inform and guide next generation sequencing (NGS), through its online portal (“PrecisionFDA”), which is intended to provide a community platform for NGS assay evaluation and regulatory science exploration. Her paper provides a useful overview of crowdsourcing to generate and manage large volumes of information about genetic variants and related biomarkers for disease (as well as drug response), as well as a thorough description of the PrecisionFDA platform. She ends with a few legal and regulatory questions that may emerge including, for instance, questions about the intellectual property status of information shared and collected. (Professor Paradise also posted Case Note: Sandoz v. Amgen, a short paper for the FDLI Update, summarizing the Supreme Court’s recent decision on the patent litigation provisions of the BPICA, as well as — as already noted — the abstract of a law review article relating to FDA’s “silence” on patent issues.)
Rachel Sachs, Administering Health Information (forthcoming in Cardozo Law Review). Professor Sachs (Washington University, in St. Louis) explores the potential for three federal healthcare agencies (NIH, CMS, and FDA) to collaborate in order to promote the development of new and innovative health technologies and improve access to those technologies. She starts with a description of the innovation incentives administered by each agency, taking a broad view of what constitutes an innovation incentive in the first place. (Thus, for instance, approval of a new drug is considered an incentive to produce information about its safety and effectiveness. And, as she has argued elsewhere, prescription drug insurance administered through CMS provides a reward for research and development and thus operates as an incentive.) Following a discussion of three methods of collaboration among these agencies – information sharing, research, and decision making (such as product approvals) – she discusses a variety of specific collaborations that might improve innovation incentives (broadly understood), noting their success and failure to date. For instance, she covers coordination between the FDA approval process and CMS coverage decisions, noting where it has been attempted and where it has not yet been used (publicly). The paper concludes with a discussion of the barriers to collaboration and ways to facilitate collaboration.