Medicines for the prevention, diagnoses, treatment, or curing of disease are an integral part of modern health care, while questions of access, affordability, value, and continued innovation are increasingly central to the health policy conversation.
This panel provided a high-level overview of health care coverage programs in the United States, such as Medicare, Medicaid, the Affordable Care Act, and employer-based insurance, as well as recent changes to coverage such as bolstering subsidies. This Session:
The U.S. Food and Drug Administration (FDA) is responsible for “the safety and efficacy” of biologic products and medical devices, along with other veterinary, food supply, and cosmetic products that are marketed or sold in the U.S. It carries out this authority by reviewing manufacturers’ applications to sell these items in the United States. During […]
This event was Part IV of the Alliance’s Health Policy Roundup and 2022 Forecast series. Download a summary of this event » Since the passage of the first User Fee Act in 1992, user fee programs have helped finance the Food and Drug Administration (FDA)’s review of human medical products such as drugs and medical devices. By authorizing the collection of user […]
In the United States, it is estimated that 1 in 10 Americans are affected by rare diseases, which is defined as any disease that affects fewer than 200,000 Americans at any given time. In order to obtain a clinical diagnosis, many patients undergo a process called the diagnostic odyssey. This process begins when a patient […]
Download an overview of this event for easy sharing » The Centers for Medicare & Medicaid Services is the largest payer for health care in the United States. Nearly 38 million Americans rely on health care benefits through this program, 61 million when Medicare Advantage beneficiaries are included. Since taking effect in 2006, Medicare beneficiaries […]
This multi-day virtual academy equipped staffers at the start of their career in health policy (or those that needed a refresher) with practical knowledge about fundamental facets of the health care system and the policymaking process. Sessions will feature speakers with experience working in/with federal policy institutions, including Congress and the executive branch. Topics addressed […]
Download an overview of this event for easy sharing » The journey to a post-COVID era is a difficult one. Although two promising vaccines are currently authorized for emergency use and more than 4.2 million people received the first of two required doses as of January 3, 2021, the United States fell short of its goal […]
As of December 2020, 27% of the public says that they probably or definitely would not receive a COVID-19 vaccine, even if it were free and deemed safe by scientists. Reasons for hesitancy include worries about potential side effects, lack of trust in the government, concern that the vaccine is too new, and concern about […]
Biosimilars Toolkit: Unpacking Complex Issues
The Alliance for Health Reform has released a new toolkit, “Biosimilars: Unpacking Complex Issues.” The Affordable Care Act created an expedited licensure pathway for biosimilars, and, in March 2015, the U.S. approved the first biosimilar, leaving policy makers, regulators, providers and stakeholders to grapple with regulatory and financial questions.
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 […]
Members of Congress, Congressional and agency staff, federal, state, and local legislators.
Health Care Stakeholders
Industry stakeholders, practitioners and providers, patient advocates, community organizations, academics.
Members of the press, journalists, public relations professionals.