Recommended Reading: Recent Scholarship on Drug and Device Regulation
Written on December 2, 2011 by George Moowattin
In Patients Over Politics Addressing Legislative Failure in the Regulation of Medical Products (forthcoming in the 2011 volume of the Wisconsin Law Review and available on SSRN), Efthimios Parasidis proposes a significant expansion of drug and device companies responsibility to engage in active post-market analysis of drugs and devices, to be coupled with a new rule that only companies that conducted such analysis would benefit from preemption of state tort claims. Professor Parasidis article includes a nuanced and revealing analysis of the historical and other reasons for the Food and Drug Administrations heavy focus on pre-market review of drugs at the expense of post-market surveillance, as well as useful updates on both the caselaw regarding the preemption of claims involving branded drugs, generic drugs, devices, and vaccines and the ongoing efforts to use health information technology to glean information about the safety and efficacy of marketed products. Most notable, though, is the articles thorough explication of Professor Parasidis interesting proposal that preemption laws, which often are enacted pursuant to industry lobbying efforts [be linked to] protocols that further the public health.
In Enforcing Integrity (forthcoming in the 2011 volume of the Indiana Law Journal and available on SSRN), Katrice Bridges Copeland makes a strong case for her conclusion that neither the exclusion of pharmaceutical manufacturers from Medicare and Medicaid a punishment which the government is reluctant to impose because it would spell the end for the company nor the use of corporate integrity agreements coupled with large fines which manufacturers agree to in order to avoid exclusion works to deter illegal marketing activities. As Professor Copeland notes, numerous companies have learned that the punishment for multiple offenses is simply another CIA and another fine. She recommends that the government consider a number of alternative penalties for repeat offenders, including (1) requiring that manufacturers fund clinical trials studying the off-label uses for which they promoted their products, (2) requiring that they license the product or products at issue to other manufacturers, (3) holding high-level individuals criminally liable under the responsible corporate officer doctrine, and (4) amending the Social Security Act to allow for the exclusion of particular drugs (as opposed to entire companies) from Medicare and Medicaid.
Finally, I recommend Seton Hall Laws own Jordan Paradises fascinating article, Claiming Nanotechnology Improving USPTO Efforts at Classification of Emerging Nano-Enabled Pharmaceutical Technologies (forthcoming in the 2011 volume of the Northwestern Journal of Technology and Intellectual Property and available on SSRN), in which she argues that the United States Patent and Trademark Offices system for classifying patents on nanotechnology-related inventions, [w]hile undoubtedly helpful for internal purposes, cedes too much to the courts. Reviewing the facts of the recent case Elan Pharma International v. Abraxis Bioscience, which involved a dispute over two patents describing nano or near-nano scale versions of the same existing cancer-fighting agent and was tried to a jury verdict, Professor Paradise points out several ways in which the patents claims potentially overlap. She argues that the courts are a clumsy forum for sorting out the complex patent law issues that arise based on scale, size, and interactions at the nanoscale that transcend previously envisioned physical and chemical boundaries[,] and offers concrete recommendations for steps the USPTO can take to improve its classification efforts to reduce the number of patents with potentially overlapping claims thereby making court involvement less necessary.
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