When patients and voters like you speak up on health care issues, you make it possible for millions of Americans to experience savings at the pharmacy counter and to lead healthier and more productive lives.
Access to Samples (REMS/CREATES Act)
Current FDA-mandated Risk Evaluation and Mitigation Strategies (REMS) are designed to serve a clear public health purpose – that of ensuring that the benefits of a drug outweigh its safety risks. AAM and the Biosimilars Council are working to strengthen REMS programs to ensure that they are properly used to protect patients and cannot be used to promote anti-competitive business practices.
The Generic Drug User Fee Amendments (GDUFA) represent a historic FDA program that aims to promote safety, access, and transparency in the generic pharmaceutical industry. AAM and its members share and fully support FDA's GDUFA objectives.
Prescription drugs treat conditions and improve patient health. But when drug prices are too high, access to medicines becomes out of reach for far too many patients. Access to generic and biosimilar medicines provides a market-based solution for lowering drug prices for all Americans.
AAM opposes abuses of the patent system by brand-name drug companies, and we advocate for patent reform that lends itself to timely patient access to safe, effective and more-affordable medicines for patients in the United States.