National Survey of Factors Associated with Physician Antibiotic Prescribing Preferences.

Background: The development of new infectious disease therapies has become a public health priority given the suboptimal efficacy and adverse effects with current drugs for some patients. Understanding the factors associated with physician antibiotic prescribing preferences can help guide policymakers seeking to incentivize the development of interventions that improve patient outcomes for the treatment and prevention of infectious diseases.

Objectives: To determine the factors associated with physician decision-making when prescribing antibiotics for community-acquired pneumonia (CAP), uncomplicated urinary tract infection (UTI), and cellulitis.

Differential Legal Protections for Biologics vs Small-Molecule Drugs in the US.

Importance: Biologics approved by the US Food and Drug Administration (FDA) receive 12 years of guaranteed protection from biosimilar competition compared with 5 years of protection from generic competition for new small-molecule drugs. Under the 2022 Inflation Reduction Act, biologics are exempt from selection for Medicare price negotiation for 11 years compared with 7 years for small-molecule drugs. Congress codified these differing legal protections on the premise that biologics require more time and resources to develop and have weaker patent protection, necessitating additional protections for manufacturers to recoup their development costs and generate adequate returns on investment.

Does Policy Uncertainty Boost Vaccine Hesitancy? Political Controversy, the FDA and COVID-19 Vaccine Hesitancy in Fall 2020.

Context: Vaccine hesitancy is associated with political and institutional distrust, but there is little research on how people's trust responds to political events. We revisit the fall of 2020 when evaluation of new COVID-19 vaccines collided with an impending national election. Drawing on a political Bayesian perspective, we assess abrupt changes in attention to political events and test hypotheses on subpopulation response: (1) partisan, (2) educational, and (3) ethnic and racial.

Comparing supplemental indications for cancer drugs approved in the US and EU.

Importance: Cancer drugs initially granted regulatory approval for one disease may also prove useful in treating other diseases. In these cases, manufacturers may seek to add supplemental indications to their drug labels. The extent to which manufacturers seek supplemental indications for cancer drugs may differ in the US and EU.