The push to improve Americans’ use of effective and less-expensive generic medications is getting a much-needed push from the Generic Drug User Fee Act currently being negotiated between the Food and Drug Administration and the generics industry.
This act can help improve access to complex generic medicines. That’s important for people with almost any condition, and is especially important for those with asthma and allergies, who I represent as president and CEO of the Allergy & Asthma Network. The goal of the Generic Drug User Fee Act is to speed FDA approval of new generic drugs, which will stimulate competition for branded drugs and reduce drug prices for consumers.
I applaud the FDA for the success the program has yielded to date, but there is more work that needs to be done, specifically for complex generics — copies of medicines that are more complex than a conventional pill but that are not biologic medicines. Innovation is driving the development of these complex medicines, which are often more patient-centric. Yet many of these have taken years to win approval due to inefficiencies in the existing FDA process.
