Promote Regulatory Certainty By Reauthorizing UFA


The House passed bipartisan legislation last week that could help reduce costs and ensure continued innovation for the future. While this legislation might not be covered as extensively as other issues, it nonetheless represents meaningful progress.

This week, the Senate HELP Committee passed the Senate version, the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act, a reauthorization of Prescription Drug User Fee Act (PDUFA), the Biosimilars User Fee Act (BsUFA), and the Generic Drug User Fee Amendments (GDUFA). These UFA programs are widely recognized as cooperative success stories that fundamentally improve patient outcomes. Consequently, these Acts deserve swift reauthorization, which must be done every five years, without the baggage that may come from any unrelated policy issues.

The UFA process provides the FDA with the resources and authority to expeditiously approve new medicines. A more efficient FDA drug approval process is critical for achieving the dual goals of improved drug affordability and increased drug innovation.

BsUFA and GDUFA expedite the approval of new lower-cost competitive medicines that expand affordability. The huge and growing amount of annual savings from both generics and biosimilars are due, in part, to the efficient UFA process.

GDUFA has helped the FDA increase the number of full and tentative generic drug approvals to more than 1,000 from 2017 to 2019. Thanks to the robust generics market, low cost generic medicines now represent 90% of all drugs prescribed. Since 92% of generics are filled for $20 or less, GDUFA has been an important enabler of the more than $300 billion in drug savings from generic medicines.

Similarly, the growth in the biosimilars market has been facilitated, in part, by the more efficient drug approval process BsUFA has fostered. As a result, patients are saving billions of dollars annually. In fact, in a forthcoming analysis, I estimate that the steep decline in prices incentivized by biosimilars have reduced expenditures by more than $11 billion compared to the prices that prevailed pre-competition in the high-cost/high-value biologic drug classes.

Perhaps more important for the BsUFA reauthorization, future biosimilar competition promises even greater savings for patients in the future. For instance, should the biosimilar competitors to Humira and Enbrel price themselves at the average current discount of 50% to the pre-competition price, and these drugs achieve a 75% market share, these medicines would generate nearly $6 billion in savings.

The UFA process is just as important for spurring innovation as it is for driving affordability. Innovative medicines have significantly improved patient outcomes across a wide range of diseases such as cancer and autoimmune diseases. Importantly, there are many exciting future possibilities. Take Facioscapulohumeral muscular dystrophy (FSHD) as an example.

FSHD is a rare muscle disease that affects patients’ face, shoulders, upper arms, and lower legs. It is a progressive disease, so time delays matter to the patient community. Currently there are no treatments for FSHD, but there is hope. Exciting treatments for FSHD, such as Fulcrum’s Losmapimod, are demonstrating potential promise and are at different stages of review with the FDA. An efficient UFA process helps expedite the review process for these drugs and could hopefully result in the availability of an efficacious treatment for patients who currently have none.

Whether it is PDUFA, BsUFA, or GDUFA, the UFA programs play an invaluable role strengthening the FDA’s ability to review new drug applications. The revenues generated by the user fees provide an efficient mechanism to fund the necessary regulatory infrastructure and personnel to review the drugs. The reauthorizations also contain timely updates.

For example, the re-authorizations increase flexibility in the filing and review processes, accelerates supplemental reviews, expands the use of patient preference data, and advances the use of novel clinical trial designs. Updates such as these to the review process ensure that the regulatory review process better reflects the needs for modern drug development.

Over decades, UFAs have demonstrated their value by accelerating patients’ access to safe and efficacious medicines. They are unqualified successes. Bogging down the process by attaching irrelevant legislation to these user fee agreements injects unnecessary uncertainty and could create delays that risk the fundamental benefits these Acts enable. Patient welfare is best served by passing clean UFA reauthorizations that ensure these important bills do not suffer needless delays.


Nothing contained in this blog is to be construed as necessarily reflecting the views of the Pacific Research Institute or as an attempt to thwart or aid the passage of any legislation.

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