FDA Drug Competition Action Plan
What is DCAP?
In 2017, FDA announced the Drug Competition Action Plan (DCAP) to further encourage robust, timely market competition for generic drugs and help bring greater efficiency and transparency to the generic drug review process, without sacrificing the scientific rigor underlying our generic drug program. Through DCAP, FDA is helping remove barriers to generic drug development and market entry, and spur competition that improves consumers’ access to the medicines they need. DCAP also aligns with most recent reauthorization of the Generic Drug User Fee Amendments (GDUFA III), which includes new enhancements designed to maximize the efficiency and utility of each assessment cycle, with the intent of reducing the number of review cycles for generic drug applications and facilitating timely access to quality, affordable, safe and effective generic medicines. Bringing more drug competition to the market is a top priority of the Administration, Department of Health and Human Services (HHS), and FDA.
DCAP Priorities
The Agency has focused its efforts under DCAP in three key areas:
Streamlining standards for complex generic drugs
Complex generic products are typically harder to develop, which means that many complex products face less competition than other products, and therefore, can be more expensive and less accessible to the patients who need them. The initiatives below aim to ensure that FDA’s regulatory requirements for complex generic drugs are streamlined, predictable, and science-based, to help reduce the time, uncertainty, and cost of drug development.Closing loopholes to prevent delays by brand-name companies
FDA aims to reduce the so-called “gaming” that frustrates and delays generic drug approvals and extends brand monopolies beyond what Congress intended with the Hatch-Waxman Amendments of 1984. Such practices upset the careful balance that Congress sought between product innovation and access, and can make the development and approval process unpredictable and potentially more costly for generic manufacturers. By preventing these delays, FDA can improve access to generic drugs.Improving the generic drug approval process
By clarifying FDA’s regulatory expectations for new entrants and experienced drug developers alike, FDA is supporting prospective generic drug developers and improving the overall quality of ANDAs submitted to the Agency for approval. At the same time, FDA continues to implement new initiatives to enhance its own review process efficiency to improve the speed and predictability of the generic drug review process, while maintaining rigorous scientific standards.
Recent DCAP Updates
- In October 2024, FDA revised 814 draft Product-Specific Guidances (PSGs) for many immediate-release oral drug products. The revised PSGs recommend that ANDA applicants conduct one BE study for products with a non-high risk of bioinequivalence due to food effect, under either fasting or fed conditions, rather than conducting two BE studies.
- In October 2024, FDA published the guidance for industry, "Review of Drug Master Files in Advance of Certain ANDA Submissions under GDUFA." This guidance provides information and recommendations on GDUFA III program enhancements related to the early assessment of certain Type II drug master files (DMFs) 6 months prior to the submission of certain ANDAs or associated PASs.
- In October 2024, FDA published the guidance for industry, "Requests for Reconsideration at the Division Level Under GDUFA." This guidance provides recommendations on the procedures for ANDA applicants that wish to pursue a request for reconsideration within the review discipline at the division level or original signatory authority.
- In September 2024, FDA published the guidance for industry, "ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFA ." This guidance describes how the assessment goals under GDUFA III apply to amendments to either ANDAs or prior approval supplements (PASs) submitted to FDA. FDA has recorded a webinar providing a guidance overview.
- On August 19, 2024, OGD published the guidance for industry, "Product-Specific Guidance (PSG) Meetings Between FDA and ANDA Applicants Under GDUFA." The guidance provides recommendations on PSG meetings between FDA and prospective applicants or applicants that have submitted ANDAs.