Accelerated Approval, Clinical Trial Diversity Provisions Left Out Of Senate User Fee Bill

Two of the most prominent features of the House package are not addressed in the Senate measure, which predominantly focuses on cosmetics, dietary supplements and laboratory developed tests. The absence of competing proposals suggests a smooth conference process.

Capitol ven diagram — There's not much overlap in the content of the House and Senate user fee bills. • Source: Nielsen Hobbs; the Pink Sheet | Shutterstock image

The draft Senate bill reauthorizing US Food and Drug Administration user fee programs is strikingly different from the House version, as it does not address the accelerated approval pathway or clinical trial diversity, two of the most significant provisions in the House measure.

The leaders of the Senate Health, Education, Labor and Pensions (HELP) Committee released a discussion draft of the bill,...