FDA Drug Competition Action Plan
What is DCAP?
In 2017, FDA announced the Drug Competition Action Plan (DCAP) to further encourage robust and 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 this plan, FDA is helping remove barriers to generic drug development and market entry in an effort to spur competition so that consumers can get access to the medicines they need. Bringing more drug competition to the market is a top priority of the Administration, the 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 are aimed at ensuring 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. - 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 is implementing initiatives to enhance its own review process efficiency to improve the speed and predictability of the generic drug review process while maintaining our rigorous scientific standards.
Recent DCAP Updates
- 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.
- In June 2024, FDA published an update to the “List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic” (OPOE list). The OPOE list includes approved new drug applications for drug products that are not protected by patents or exclusivities at the time of each update, and for which FDA has not approved an abbreviated new drug application referencing that NDA.