Digital Commons Network^™

The Role Of State Attorneys General In Improving Prescription Drug Affordability, Michelle M. Mello, Trish Riley, Rachel Sachs

Scholarship@WashULaw

Impact litigation initiated by state attorneys general has played an important role in advancing public health goals in contexts as diverse as tobacco control, opioids, and healthcare antitrust. State attorneys general also play a critical role in helping governors and legislatures advance health policies by giving input into their drafting and defending them against legal challenges. State attorneys general have entered the prescription drug affordability arena in both these ways—for example, by initiating lawsuits relating to price fixing by generic drug manufacturers and defending state laws requiring disclosures of pharmaceutical prices. Yet the scope of their collective efforts is not …

New Innovation Models In Medical Ai, W. Nicholson Price Ii, Rachel Sachs, Rebecca S. Eisenberg

Scholarship@WashULaw

In recent years, scientists and researchers have devoted considerable resources to developing medical artificial intelligence (AI) technologies. Many of these technologies—particularly those that resemble traditional medical devices in their functions—have received substantial attention in the legal and policy literature. But other types of novel AI technologies, such as those related to quality improvement and optimizing use of scarce facilities, have been largely absent from the discussion thus far. These AI innovations have the potential to shed light on important aspects of health innovation policy. First, these AI innovations interact less with the legal regimes that scholars traditionally conceive of as …

Reforming Reimbursement For The Us Food And Drug Administration’S Accelerated Approval Program To Support State Medicaid Programs, Rachel Sachs, Julie M. Donohue, Stacie B. Dusetzina

Scholarship@WashULaw

Importance The US Food and Drug Administration (FDA) has an accelerated approval program that has become the subject of scholarly attention and criticism, not only for the FDA’s oversight of the program but also for its implications for payers.

Observations State Medicaid programs’ legal obligations to provide reimbursement for accelerated approval products have created fiscal challenges for Medicaid that have been exacerbated by industry’s changing use of the accelerated approval program over time. Although strategies for accelerated approval reforms have been proposed, most focus on reforming the FDA’s accelerated approval pathway and product regulation without taking into account the implications …