Recently, the House Energy and Commerce Committee and Senate Health, Education, Labor and Pensions (HELP) Committee introduced a bipartisan discussion draft of legislation to reauthorize the Food and Drug Administration’s (FDA) user fee programs. The legislation reauthorizes fees for pharmaceuticals, generics, biosimilar and medical devices through 2022. A section –by–section summary of the draft prepared by the HELP Committee is here.
The reauthorization of the FDA user fee programs normally serves as the platform for an array of legislative proposals that could not move on their. However, Congress this time around stuck to the fees and provisions negotiated between the FDA and industry.
The Fiscal Year (FY) 2018 base fee structures and selected changes to the programs are as follows (taken from the section–by–section document):
- Prescription Drug User Fee Amendments (PDUFA VI): $878,590,000 up from $718,669,000 in FY 2017. The draft proposes to change the fee structure from the current one-third from facility fees, one-third from various application fees, and one-third from product fees to 20 percent application fees and 80 percent program fees for approved products.
- Generic Drug User Fee Amendments (GDUFA II): $493,600,000, up from $299,000,000 in FY 2017. The draft proposes to change the applicant program fee by tying it to the number of applications the applicant has approved by the FDA under the following scheme:
- 20 or more approved applications pays the full fee;
- Six to 19 approved applications pays 40 percent of the full fee; and
- Five or fewer approved applications pays 10 percent of the full fee.
- Biosimilar User Fee Amendments (BsUFA II): $45,000,000, up from $20,000,000 in FY 2017. The draft establishes an independent fee structure for biosimilars for the first time based on the following types of fees:
- Initial Biosimilar Development Fee for the first year once a sponsor begins clinical trials for a new biosimilar;
- Annual Biosimilar Development Fee for subsequent years a sponsor is developing a new biosimilar;
- Biosimilar Program Fee for sponsors of approved biosimilars; and
- Application Fee for new biosimilar applications.
- Medical Device User Fee Amendments (MDUFA IV): $183,280,756, ending at $213,687,660 in FY2022, up from $130,184,348 in FY2017. The draft adds authority to collect fees for “de novo classification” requests. According to the FDA, these classifications for are “novel devices of low to moderate risk that had automatically been placed in Class III after receiving a ‘not substantially equivalent’ (NSE) determination in response to a premarket notification.” The draft also updates the target base fee amounts for each year and allows the Secretary of HHS to, if necessary, increase the fees to meet the base target.
To meet the statutory September 30, 2017 deadline for reauthorizing the user fees, the House and Senate committees will have to hold mark-ups in mid-May and then bring the bills to a vote before Memorial Day. While the bipartisan leadership of Energy and Commerce and HELP Committees are optimistic these steps can accomplished, the precise timing may be impacted by negotiations with various factions in Congress to not bog down the process by offering amendments with extraneous provisions (i.e., drug pricing) during consideration. We will be watching the process and politics closely.