Congress will soon have the chance to make generic drugs, including complex generics, more accessible and affordable for Americans.
Under current law, the Food and Drug Administration assesses a pharmaceutical company a fee when it applies for a generic drug approval. The resources are used to improve the timeliness and predictability of generic drug applications. The process is set up under the Generic Drug User Fee Amendments, which are up for reauthorization in 2022. Reauthorization presents an opportunity for policymakers to make federal processes more economical, efficient and effective.
As noted in a recent webinar by the Alliance for Patient Access, the FDA needs input from patients, families, caregivers and patient advocates, whose experiences can inform the FDA’s understanding of the multifaceted value of generic drugs. The Asthma and Allergy Foundation of America and Allergy & Asthma Network co-sponsored the webinar.
What Generic Drugs Offer Patients
A generic drug contains the same active pharmaceutical ingredient as the original medication and delivers equal medical benefits to patients. Generic drugs can:
- Expand treatment choices
- Lower prices
- Improve supply security
- Encourage pharmaceutical companies to explore innovative new medications.
With more than half of U.S. adults consistently taking at least one prescribed medication, drug affordability in particular is an important benefit. Across the United States, 90% of prescriptions are filled with generic products, which cost – on average – 80-85% less than brand-name drugs. Over the last decade, patients have saved more than $2.2 trillion by using generic drugs.
Increasing Competition Is Key
Participants in the webinar noted that patients want an increase in first-generation generic approvals and a focus on complex generic applications. The FDA defines a complex generic as a generic that could have a complex active ingredient, formulation, route of delivery or drug device combinations. The added complexity makes complex generic development and approval more difficult, but ensuring competition could lead to significant savings for patients.
Expanding generic drug competition is essential to lowering prescription drug prices for individual patients and reducing overall drug spending. The FDA can do its part to encourage competition by reducing the backlog of applications awaiting review. Incentivizing competition and speeding up drug approvals can, in turn, bring down costs, making prescription drugs more affordable and accessible for patients.
Collaboration & Progress
By educating and collaborating with the FDA to set priorities for generic drug development, advocates can bring the patient perspective to this important process. Patient input can inform FDA’s resourcing and prioritization of generic approvals, ultimately improving uptake and benefit from generic medications. The Generic Drug User Fee Amendments have delivered tremendous benefits for patients and the economy. With patients’ perspectives front and center, legislators and regulators can continue to prioritize access to generic medications in the years ahead.
