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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

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
  • Draft Guidance for Industry: Harmonizing Compendial Standards with Drug Application Approval Using the USP Pending Monograph Process (July 2019)
  • Draft Guidance for Industry: Using the Inactive Ingredient Database (July 2019)
  • List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic (Updated June 2019, December 2018, June 2018, December 2017; originally published June 2017)
  • Updates to FDA’s website on Patent Certifications and Suitability Petitions (June 2019)
  • Final Guidance for Industry: Determining Whether to Submit an ANDA or a 505(b)(2) Application (May 2019)
  • Draft Guidance for Industry: Competitive Generic Therapies (February 2019)
  • Draft Guidance for Industry: CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality (February 2019)
  • Draft Guidance for Industry: ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs (January 2019)
  • Final Guidance for Industry: Amendments to Abbreviated New Drug Applications Under GDUFA (July 2018)
  • Draft Guidance for Industry: Good ANDA Submission Practices (January 2018)
  • MAPP: Good ANDA Assessment Practices (January 2018)
  • Addition of patent submission dates to Approved Drug Products with Therapeutic Equivalence Evaluations – known as the “Orange Book” – where available (November 2017)
  • Revisions to the Prioritization of the Review of Original ANDAs, Amendments, and Supplements MAPP (November 2017, June 2017)
  • Draft Guidance for Industry: ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications (Pre-Submission Facility Correspondence) (November 2017)
  • Updated Practice – FDA will issue product-specific or product-class specific guidance on how generic copies of newly approved, non-complex new chemical entity drugs can be developed, and make such guidance available at least two years prior to the first lawful ANDA submission date. (October 2017)

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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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