A Prescription for Pharmaceutical’s Future:
Balancing Industry and Consumer Concerns in Pharmaceutical Drug Development
Friday, October 27, 2017 from 8:15 a.m.—4:00 p.m. (reception to follow)
Mondale Hall, University of Minnesota Law School
This event is free and open to the public. Attendees have the option of purchasing lunch through the registration form (cash or check accepted for payment).
CLE credits will be requested, and live streaming will be available the day of the event. Registration is available at: https://goo.gl/forms/Mm1Ksxv173RGGD5f1
Key Note Address by Dr. Jonathan Jarow, Senior Medical Advisor to the Director of the Center for Drug Evaluation and Research, U.S. Food and Drug Administration
- “FDA Regulation of Drugs and Biologics: Finding the Right Balance”
Introduction by Michelle M. Mello, Ph.D., J.D., Professor of Law, Stanford Law School, and Professor of Health Research and Policy, Stanford University School of Medicine
- “Why Ensuring Access to Affordable Drugs Is the Hardest Problem in Health Policy”
Address by Joanne Chan, J.D., Assistant General Counsel, Pharmaceutical Research and Manufacturers of America
Panel 1: Investigating the Pricing Equation: A Law and Economics Analysis
Pricing pharmaceutical drugs is a complex endeavor bogged down by disparate market forces and motivations. On one side of the equation, pharmaceutical companies gauge competitor prices by consulting insurers, consult providers to assess prices with treatment plans, assess input costs (such as research, development, marketing, FDA approval and other compliance measures, etc.), and determine desired profits for shareholders and the company, to name a few factors. On the other side of the equation, consumers want prescriptions and insurance premiums to be affordable and effective. The pricing process remains largely hidden, because partly Medicare cannot negotiate prices directly with drug companies. This panel confronts the underlying issues that need addressing in the pricing equation and what issues should change or remain the same.
- Arti K. Rai, J.D., Elvin R. Latty Professor of Law, Duke University Law School
- “Regulatory Gaming and Antitrust: Drugs vs. Biologics”
- Christopher Robertson, Ph.D., J.D., Professor of Law and Associate Dean for Research and Innovation, University of Arizona College of Law
- Rachel E. Sachs, M.P.H., J.D., Associate Professor of Law, Washington University School of Law
- “The Role of Reimbursement”
- Stephen W. Schondelmeyer, PharmD, Ph.D., Professor and Head of the Department of Pharmaceutical Care and Health Systems, Director of the PRIME Institute, University of Minnesota
Panel 2: “Safe & Effective” or “Now & Cheap”?: Finding the Right Role for the FDA
The FDA, its mission, and its powers are partially the result of Congressional response to a series of national incidents sparked by bad drugs and public outcries. Such a history lends itself to a potentially incoherent or incomplete mission. In fact, critiques of the FDA have suggested that its mission is in one sense too broad because it must investigate drugs for effectiveness and not merely safety. Others have suggested that the FDA’s commitment to be only scientific in its approval process is too narrow and does not allow for the consideration of other relevant factors, such as immediate need of the product. State right to try laws, in which terminally ill patient may try drugs before FDA approval, exemplify one way that lawmakers challenge the approval process. As with any administrative agency, there are also issues of “mission creep” and exceeding statutory bounds, often to consider factors in drug approval that are not statutorily permitted. This panel will explore potential changes to the statutory mission and authority of the FDA. What should be its fundamental mission? What factors should it be allowed to consider? Have we already struck the proper balance?
- Amy Kapczynski, M.A., J.D., Professor of Law and Faculty Director of the Global Health Justice Partnership, Yale Law School
- Jordan Paradise, J.D., Professor of Law, Loyola Chicago School of Law
- “Regulatory Silence at the FDA: Impact on Drug and Biologic Competition”
- Nicholson Price II, J.D., Ph.D., Assistant Professor of Law, University of Michigan Law School
- “Drug Approval in a Learning Health System”
Panel 3: Pharmaceuticals Around the Globe: Access and Delivery Issues for Consumers
A final vital aspect of pharmaceutical drug development concerns bringing these drugs to consumers. Due to the expense of drug research and development, pharmaceutical companies need to make careful decisions on what products to pursue. However, consumers, particularly those consumers in poor areas, can suffer from the unavailability of particular pharmaceuticals or underdeveloped pharmaceuticals. Moreover, the pharmaceutical drugs that even are available might not be delivered competently. How does the intellectual property regime influence this phenomenon? Is pharmaceutical research and development compatible with social justice, and how so? What kinds of reforms are needed, and what is feasible for businesses? This panel will tackle both the international community’s need to respond as well as the United States’ role in response efforts.
- Margo A. Bagley, J.D., Asa Griggs Candler Professor of Law, Emory University School of Law
- “Making Room at the (Drug Access) Table: Is There a Place for Traditional Medicine?”
- James Love, Director, Knowledge Ecology International
- Jerome H. Reichman, J.D., Bunyan S. Womble Professor of Law, Duke University Law School