ASPIRE signs on to letter to FDA regarding Complex Generics

ASPIRE cosigned the Association for Accessible Medicines’ letter to the FDA urging them to prioritize patient access to more safe, effective, and affordable complex generic medicines in Generic Drug User Fee Amendment (GDUFA III). Please see the list of other organizations that signed on as well.

The undersigned groups represent patients and consumers who rely now – and will in the future – upon complex medicines that treat a variety of serious and chronic illnesses. Greater availability of generic versions of these medicines would improve accessibility and affordability for those patients who are most likely to already have high medical costs.

Many American adults–nearly 60 million, according to some recent consumer surveys–have difficulty affording their prescription drug medicines even with insurance, putting their health and financial priorities at odds. Complex generics have the potential to generate significant savings for patients and the health care system. But market dynamics and regulatory complexities are seen as significant hurdles.

Looking ahead, we urge FDA to commit to twin goals: 1/ increased efficiency of generic reviews; and 2/ greater attention to the next generation of generic drugs – complex generics – that, by their nature, require a more intensive review. Appropriated and user fee funding needs to be sufficient to do both.

  • Association for Accessible Medicines
  • Allergy & Asthma Network
  • Alliance for Patient Access
  • Alliance to Solve PANS & Immune-Related Encephalopathies
  • Asthma and Allergy Foundation of America
  • Consumer Action
  • Friends of Cancer Research
  • International Pemphigus Pemphigoid Foundation
  • National Alliance on Mental Illness
  • Prevent Cancer Foundation


Leave a comment