FDA User Fee Programs

Millions of Americans rely on medications to treat their condition. All medications are reviewed by the U.S. Food and Drug Administration, or FDA, and only those that are determined to be safe and effective are approved for use. This process, however, can be time consuming and costly. In recent decades, Congress has established programs to […]
Biologic Medication and Specialty Pharmacies: A Patient’s Guide

Getting the right care is critical to a patient’s health. But unlike traditional medications, biologics—innovative treatments made from natural and living sources designed to treat various health conditions— can be more challenging to access. Read One Pager >
Navigating Insurance Barriers for Biologic Medication

Accessing biologic medication—innovative treatments made from natural and living sources—isn’t always easy. These treatments, often injected or infused, are not always available to patients due to roadblocks from insurance companies. Read One Pager >
Focus on Access: Navigating Medicare Part B Negotiation and Its Unintended Consequences Brief

A cornerstone of the Inflation Reduction Act (IRA) of 2022 is the Medicare Drug Price Negotiation Program, which empowers the Centers for Medicare & Medicaid Services (CMS) to directly negotiate prices for a select number of high-expenditure Part D and, beginning in 2028, Part B drugs Read Brief >
Oncology and Care Pathways

Oncology care pathways are treatment guidelines designed to help clinicians deliver cancer care that is cost-effective and based on evidence. Typically developed by health systems and insurers, and endorsed by national cancer organizations, these pathways offer a structured approach to treating specific cancer types at varying stages. Read One Pager >
Access Barriers & Serious Mental Illness: Improving Timely, Consistent Access to Mental Health Treatment

More than 15 million Americans suffer from serious mental illness, or SMI. For each of them, access to effective, personalized care can be the difference between stability and crisis, independence and hospitalization — or even life and death. Yet far too many patients face real barriers that keep them from the clinicians, medications and therapies […]
Obesity in Rural America

Obesity is a chronic disease that impacts millions of Americans, but it is more prevalent in rural populations. Approximately 48% of adults in non-metropolitan areas live with obesity. Improving access to obesity care in rural areas will improve quality of life for many Americans. Read One-Pager >
Friedreich’s Ataxia: A Rare Condition Facing Common Access Challenges

Friedreich’s ataxia (FA) is a rare progressive neurological condition that usually presents in childhood with balance and gait issues but ultimately results in life-altering fatigue, loss of mobility, and for many, multi-system failure and premature death due to cardiomyopathy. Read paper >>
How Alternative Funding Programs Harm Rare Disease Patients

People with rare diseases deserve timely access to care for their condition. But alternative funding programs are a new threat to rare disease patients’ access. Read One-Pager >
Vaccines for Every Age

Immunizing as you age benefits adults and their communities. Read One-Pager >