The Food and Drug Administration (FDA) is a critical federal agency for protecting public health. Its many areas of oversight include ensuring that prescription medications marketed in the US are sufficiently safe and effective. Research from PORTAL has been critical for informing FDA policies, including how to ensure rigorous pre-market evidence generation and appropriate post-approval monitoring.
Research Areas We Explore:
- Evidentiary Standards for FDA Approval: The quality and rigor of clinical evidence supporting FDA drug and device approval decisions, including the growing reliance on surrogate measures and the increasing use of expedited regulatory pathways like accelerated approval to bring drugs to market.
- Post-Market Surveillance and Safety: How the FDA monitors drugs and devices after approval, including oversight of manufacturer adherence to post-marketing study requirements and commitments, the effectiveness of Risk Evaluation and Mitigation Strategies (REMS), and the role of evidence gathered from routine clinical use in safety monitoring.
- Comparative Effectiveness and Clinical Decision-Making: Generating head-to-head comparative evidence that patients and physicians need to make informed treatment decisions, and evaluating the role of academic detailing and evidence-based prescribing programs to clearly communicate drug benefits and risks.
- Public Input and Transparency: The role and use of FDA advisory committees, the influence of patient testimony and public comment on regulatory decisions, and the reforms needed to strengthen the independence, transparency, and consistency of FDA decision-making to maintain public trust.
- Off-Label Use and Drug Advertising: The legal and regulatory issues related to the FDA’s authority to restrict off-label drug marketing and the influence of direct-to-consumer advertising and industry promotion on prescribing behavior.
