Helping remove barriers to generic drug development and market entry so consumers can access needed medicines

Bringing more drug competition to the market is a top priority of the Administration, the Department of Health and Human Services (HHS), and FDA. 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.

DCAP Priorities

To date, the Agency has focused its efforts under the Drug Competition Action Plan in three key areas:

• Maximizing scientific and regulatory clarity with respect to 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 that allow brand-name drug companies to “game” FDA rules in ways that delay the generic competition Congress intended
  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 efficiency of the generic drug development, review, and 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 April 2024, FDA published the draft guidance for industry, “Data Integrity for In Vivo Bioavailability and Bioequivalence Studies.” This draft guidance provides recommendations to applicants and testing site management on achieving and maintaining data integrity for the clinical and bioanalytical portions of bioavailability (BA) and bioequivalence (BE) studies submitted in support of investigational new drug applications, new drug applications, and abbreviated new drug applications.
• In March 2024, FDA published the draft guidance for industry, Handling and Retention of BA and BE Testing Samples. The guidance provides recommendations for study sponsors and/or drug manufacturers, contract research organizations (CROs), site management organizations (SMOs), and investigators regarding the procedures for handling reserve samples from relevant bioavailability (BA) and bioequivalence (BE) studies.
• In March 2024, FDA published the guidance for industry, Controlled Correspondence Related to Generic Drug Development. This guidance provides information regarding the process by which generic drug manufacturers and related industry can submit controlled correspondence to FDA requesting information related to generic drug development and the Agency’s process for providing communications related to such correspondence.

Additional Resources

Further information on FDA’s Drug Competition Action Plan is available at the links below.

• FDA-USPTO Collaboration Initiatives
• Complex Generics News