No Rare Disease Patient Should be Required to Use Non-FDA Approved Products
WASHINGTON, Jan. 7, 2026 /PRNewswire/ — Alternative Funding Programs (AFPs) are shorthand for providing access to illegally procured specialty care and rare therapies. These programs force beneficiaries to jump through administrative and funding hoops to access therapies, and when these are exhausted the programs utilize importation schemes that require patients to use products sourced from countries without FDA approved labels, US warnings and patient information.
In an amicus brief filed by patient groups in the case of Gilead Sciences vs. Meritain Health, Inc., those organizations stressed “the obvious and serious risks to patient health created by Appellants’ conduct.” Further, an FDA warning letter issued to an AFP flatly concluded that importation of foreign drugs “pose significant health risks to U.S. consumers.”
According to an article in Health Affairs by Ashira Vantrees, Counsel at Aimed Alliance, “AFPs are third-party companies that work with employer-sponsored health plans to identify alternative sources for the plan participants’ specialty drugs. These alternative sources typically include PAPs, international importation, and copay assistance programs.”
These AFPs specifically classify important specialty medications (including rare or orphan therapies) as non-essential health benefits (non-EHBs) that are not subject to the ACA’s EHB coverage protections. This allows the AFP to demand that consumers utilize the AFP or be responsible for a 100% coinsurance that won’t count toward their deductible and annual out-of-pocket limit. Thus, with no other option, consumers are coerced into using the AFP to access their medication.
And in the case of Gilead Sciences vs. Meritain Health, Inc., the drug was sourced from another country with no US safety labeling or FDA approved patient educational information.
“When patients and their employers utilize the insurance that they pay for, they should be assured that the products they use are safe and labeled with FDA approved information,” said Michael Eging, Executive Director of the Rare Access Action Project (RAAP). “No plan should be pressuring patients into alternative funding schemes to avoid taking responsibility for the coverage and risk they are paid to manage. We support this amicus brief and encourage the courts to rule against these practices that threaten patient access to critical therapies, and place patients in unnecessary risk—all to protect profits.”
*Employer Plans Beware: Alternative Funding Programs May Be Riskier Than They Appear, Health Affairs, November 2024. https://www.healthaffairs.org/content/forefront/employer-plans-beware-alternative-funding-programs-may-riskier-than-they-appear
RAAP, the Rare Access Action Project, is a coalition of life sciences and patient stakeholders that explore creative policy solutions to address structural issues in access and coverage. Our priority is to help ensure rare disease patients have access to the care and treatments they need. RAAP is a registered 501 c4 non-profit organization.
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SOURCE Rare Access Action Project (RAAP)
