The draft language reauthorizes FDA’s authority to assess user fees and proposes fee restructuring and increases.
On April 14, the health committees for both the US Senate and the US House of Representatives released a discussion draft of legislation to reauthorize the Food and Drug Administration’s (FDA’s) user fee agreements. The draft language restructures the various fee programs, establishing new fees and eliminating others, while also likely increasing overall fee obligations. The committees are seeking comments from stakeholders by April 28, 2017.
FDA’s authority to assess user fees is due to expire in September 2017. The draft language proposed by the congressional health committees would reauthorize FDA’s authority to assess user fees for another five years. Highlights of the draft language include the following:
For Fees Relating to New Drug Application (NDA) and Biologic License Application (BLA) Products
For Fees Relating to Generic Drug Products
For Fees Relating to Biosimilar Products
For Fees Relating to Medical Devices
Interested persons can submit comments by April 28, 2017.
Congress is trying to move quickly to reauthorize FDA’s user fee authority as the current bills will expire on September 30. In a Senate Committee on Health, Education, Labor & Pensions press release, senators and representatives from both parties reiterated the importance of timely reauthorization of the user fee statutes for FDA, patients and their families, and industry.
Specifically for prescription drugs, biologics, generic drugs, and biosimilar products, the proposed restructured fees appear to consolidate many ancillary fees. While companies may have fewer fees that will need to be paid, their overall fee obligations will likely increase as the revenue that FDA is authorized to collect is also increasing. This increased fee obligation will be spread across fewer fee categories, which, for some fee classes, will likely result in larger invoices.
The restructuring of the user fee programs will also potentially impact existing and new contractual arrangements among companies in the life sciences industry, such as joint ventures, licensing, and contract manufacturing and supply arrangements. Accordingly, if the draft language is passed, companies should assess their current and new contractual arrangements to accommodate the new fee structure and levels.
If you have any questions or would like more information on the issues discussed in this LawFlash, please contact any of the following Morgan Lewis lawyers:
 US Senate Committee on Health, Education, Labor & Pension, “Senate, House Health Committee Leaders Release Discussion Draft of FDA User Fees Reauthorization” (Apr. 14, 2017).
 Based on the allocation of biosimilar fees in the draft legislation, it appears that the drafters may have intended to also eliminate biosimilar product fees. The text of the draft legislation, however, currently leaves these fees intact.