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  1. Guidance, Compliance, & Regulatory Information

FDA Drug Competition Action Plan

Helps remove barriers to generic drug development and market entry so that consumers can get access to needed medicines

Bringing more drug competition to the market and addressing the high cost of medicines 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 at affordable prices.

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

  1. improving the efficiency of the generic drug development, review, and approval process
  2. maximizing scientific and regulatory clarity with respect to complex generic drugs; and 
  3. closing loopholes that allow brand-name drug companies to “game” FDA rules in ways that delay the generic competition Congress intended

This page features news and information about the Drug Competition Action Plan, FDA efforts and accomplishments under the Plan, and related updates. Additional Resources are also included.

Recent DCAP Updates

  • In March 2020, FDA issued the guidance Competitive Generic Therapies. This guidance describes the process that potential ANDA applicants should follow to request designation of a drug as a CGT, outlines the criteria for designating a drug as a CGT, provides information on the actions FDA may take to expedite the development and review of ANDAs for drugs designated as CGTs, and explains how FDA implements the statutory provisions providing for a 180-day exclusivity period for certain first approved applicants that submit ANDAs for CGTs.
  • In December 2019, FDA updated the List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic. FDA maintains this list to improve transparency and encourage the development and submission of applications for drugs with limited competition.
  • In November 2019, FDA issued the draft guidance Transdermal and Topical Delivery Systems – Product Development and Quality Considerations. This guidance provides recommendations to applicants and manufacturers of transdermal and topical delivery systems regarding the pharmaceutical development and quality information to include in NDAs and ANDAs.  

Actions intended to improve the efficiency of the generic drug development, review, and approval process

The following initiatives help bring greater transparency to the generic drug review and approval process, with the ultimate goal of more approvals. 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.

To view the guidances listed below, go to Guidances for Drugs and filter by category Drug Competition Action Plan

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Actions intended to maximize 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.

To view the guidances listed below, go to Guidances for Drugs and filter by category Drug Competition Action Plan

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Actions intended to close loopholes that allow brand-name drug companies to “game” FDA rules in ways that delay the generic competition Congress intended

The third component of the Drug Competition Action Plan is aimed at reducing 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.

To view the guidances listed below, go to Guidances for Drugs and filter by category Drug Competition Action Plan

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Additional Resources

Further information on the Administration’s plan for bringing down the high price of drugs and reducing out-of-pocket costs for the American consumer, as well as additional details on FDA’s Drug Competition Action Plan, is available at the links below.

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