The U.S. Senate’s approval of the Food and Drug Administration Reauthorization Act of 2017
, which includes the Generic Drug User Fees (GDUFA) program, was a big win for SOCMA’s Bulk Pharmaceuticals Task Force (BPTF)
members and, ultimately, U.S. consumers and patients. GDUFA, initially enacted in 2012, is specifically designed to improve the quality and availability of drugs throughout the supply chain.
Reauthorization of GDUFA allows the federal government to continue to work toward bringing generic drugs to consumers faster than ever. A major component of the negotiations was to adjust the fee allocation structure to better align with the beneficiaries of these faster Abbreviated New Drug Application (ANDA) approvals. For BPTF members the new fee structure will significantly reduce the costs for active pharmaceutical ingredient (API) manufacturers. In the end, industry stakeholders concluded the new fee structure was more equitable than the fee structure authorized in the original GDUFA I authorization five years ago.
BPTF was a key stakeholder in GDUFA I negotiations, and when renegotiations for GDUFA II started more than two years ago, we once again took our place at the table and worked with FDA officials and other stakeholders to share insights and discuss concerns about implementation of the program.
Most recently, during a June 29 meeting with FDA and other industry stakeholders, BPTF provided insights and feedback on the increasing number of challenges presented by the Drug Master File (DMF) review process since GDUFA I was enacted. DMF deficiencies result in excessive information requests and longer review periods. We discussed the need for DMF enhancements as part of GDUFA II, and all stakeholders and the FDA agreed that more dialogue is needed for a more efficient review process.
Pre-submission facility correspondence and the need to reduce the increased time for review of ANDAs were also among discussions with FDA.
These on-going quarterly meetings between FDA and industry stakeholders have proven to be very productive and several key issues that will benefit all API manufacturers and DMF holders were included in the final version of the bill.
Key highlights of GDUFA II include:
- Manufacturers that have been paying API facility fees and fixed dosage form (FDF) facility fees will pay only one fee instead of two if they are located within the same facility.
No facility fees will be required until an approved ANDA references the facility, and no payment will be required while the ANDA is pending.
- The DMF Holder Fee proposed by FDA during negotiations for GDUFA II was removed in final negotiations.
- The total fee allocation structure has been adjusted better align with the beneficiaries of faster ANDA approvals.
- Total user fees collected will increase by 65 percent under GDUFA II. BPTF successfully negotiated a reduced share of the total user fees to be paid under API manufacturing facility fees and DMF application fees. The net result is that the actual cost to API manufacturers and DMF holders remains essentially unchanged. The change in the user fee allocation structure is a great benefit to API manufacturers, including many BPTF member companies.
- The new user fee structure also includes relief for small business, contract manufacturing organizations (CMOs), and pending first-time applicants, as well as FDF and joint operation (FDF/API & API + Excipient) manufacturers.
BPTF will continue working with FDA during implementation of GDUFA II, which will go into effect October 1.
To learn more about BPTF and opportunities to participate in the development and implementation of regulations impacting the pharmaceutical industry, contact Executive Director, John DiLoreto at firstname.lastname@example.org.