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Pharmaceutical Drugs Of Uncertain Value, Lifecycle Regulation At The Us Food And Drug Administration, And Institutional Incumbency, Matthew Herder

Articles, Book Chapters, & Popular Press

Policy Points

• The US Food and Drug Administration (FDA) has in recent years allowed onto the market several drugs with limited evidence of safety and effectiveness, provided that manufacturers agree to carry out additional studies while the drugs are in clinical use.
• Studies suggest that these postmarketing requirements (PMRs) frequently lack transparency, are subject to delays, and fail to answer the questions of greatest clinical importance. Yet, none of the literature speaks directly to the challenges that the FDA—as a regulatory institution—encounters in enforcing PMRs.
• Through a series of interviews with FDA leadership, this article analyzes and situates those challenges …

Revisionist History? Responding To Gun Violence Under Historical Limitations, Michael Ulrich

Faculty Scholarship

In the D.C. Circuit case Heller v. District of Columbia (Heller II), Judge Kavanaugh wrote that “Heller and McDonald leave little doubt that courts are to assess gun bans and regulations based on text, history, and tradition, not by a balancing test such as strict or intermediate scrutiny.” Now Justice Kavanaugh, will he find support on the highest court for what was then a dissenting view? Chief Justice Roberts, during oral arguments for Heller I, asked “Isn’t it enough to…look at the various regulations that were available at the time…and determine how these—how this restriction and the scope of this …

Unlocking Access To Health Care: A Federalist Approach To Reforming Occupational Licensing, Gabriel Scheffler

All Faculty Scholarship

Several features of the existing occupational licensing system impede access to health care without providing appreciable protections for patients. Licensing restrictions prevent health care providers from offering services to the full extent of their competency, obstruct the adoption of telehealth, and deter foreign-trained providers from practicing in the United States. Scholars and policymakers have proposed a number of reforms to this system over the years, but these proposals have had a limited impact for political and institutional reasons.

Still, there are grounds for optimism. In recent years, the federal government has taken a range of initial steps to reform licensing …

Drugs' Other Side Effects, Craig J. Konnoth

Publications

Drugs often induce unintended, adverse physiological reactions in those that take them—what we commonly refer to as “side-effects.” However, drugs can produce other, broader, unintended, even non-physiological harms. For example, some argue that taking Truvada, a drug that prevents HIV transmission, increases promiscuity and decreases condom use. Expensive Hepatitis C treatments threaten to bankrupt state Medicaid programs. BiDil, which purported to treat heart conditions for self-identified African-Americans, has been criticized for reifying racial categories. Although the Food & Drug Administration (“FDA”) has broad discretion under the Food, Drugs, and Cosmetics Act (“FDCA”) to regulate drugs, it generally considers only traditional …