FDA Approval Pathways 101

During this session, panelists provided an overview of the role of the FDA particularly focusing on the approval process required to bring new medical products to market.

Background on FDA User Fee Programs

The Food and Drug Administration (FDA) was first authorized to collect user fees in 1992 under The Prescription Drug User Fee Act to provide funding to the agency during a period of federal budget cuts. Over the past 30 years, user fee programs have helped finance the FDA’s review of human medical products such as drugs and medical devices.

Medicare Part D Basics and Policy Options for Redesign

This briefing will clarify the defining characteristics of Medicare Part D including eligibility, coverage, and benefits. Attendees will understand the case for Medicare Part D redesign and the implications and tradeoffs of current policy options on beneficiaries and other stakeholders.

Modernizing Medicare Part D

During this congressional lunch briefing, analysts will outline the mechanisms of the Medicare Part D program under current law and discuss the potential implications of reforms put forward by Congress and the administration.

Basics of Biosimilars

During this briefing, panelists explained the mechanisms of biologic drugs, explore the impact of current regulations on the uptake of biosimilars, and discuss considerations for the biosimilars market in the United States.

Our 2018 Speakers

Prescription Drug Costs: Can Increased Competition Restrain Prices?

This webinar will focus on the first approach and will explore different perspectives on how increasing the number of generic and biosimilar options may affect the drug pricing market. Specifically, panelists discussed the main opportunities and challenges of the generic and biosimilar market, how past administrations have approached this issue, and how different stakeholders, including consumers, are impacted.

State Opportunities to Address Prescription Drug Costs in Medicaid

The purpose of this briefing was to orient federal policymakers and stakeholders to the legislative and regulatory actions that state officials are perusing to address the rising cost of prescription drugs in Medicaid. Panelists outlined the rationale for these actions, detailed the mechanisms of state policies, and described opportunities to leverage flexibility within federal parameters.