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:
- improving the efficiency of the generic drug development, review, and approval process;
- maximizing scientific and regulatory clarity with respect to complex generic drugs; and
- 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- In November 2022, FDA published a new draft guidance for industry entitled “Sameness Evaluations in an ANDA – Active Ingredients.” The guidance is intended to assist applicants preparing an abbreviated new drug application (ANDA) by providing recommendations on demonstrating sameness between the active ingredient in a proposed generic drug product and its reference listed drug (RLD) as required under section 505(j)(2)(A)(ii) of the Federal Food, Drug, and Cosmetic Act.
- In October 2022, FDA published three draft guidances and 80 product-specific guidances providing general recommendations for physicochemical and structural characterization tests, in vitro release test (IVRT) studies, and in vitro permeation test (IVPT) studies for topical generic drug products, and one draft guidance for topical dermatological corticosteroids in vivo bioequivalence studies. These publications include:
- Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs Draft Guidance
- IVRT Studies for Topical Drug Products Submitted in ANDAs Draft Guidance
- IVPT Studies for Topical Drug Products Submitted in ANDAs Draft Guidance
- Topical Dermatologic Corticosteroids: In Vivo Bioequivalence Draft Guidance
- A batch of more than 80 product-specific guidances for topical drug products, including recommendations on Q3 characterization tests, IVRT studies, and/or IVPT studies
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.
- Final Guidance for Industry: ANDA Submissions – Prior Approval Supplements Under GDUFA (October 2022)
- Final Guidance for Industry: Information Requests and Discipline Review Letters under GDUFA, and an accompanying Manual of Policies and Procedures, Issuance of Information Requests and/or Discipline Review Letters for Abbreviated New Drug Applications (MAPP 5220.5) (October 2022)
- Final Guidance for Industry: Competitive Generic Therapies (October 2022)
- Revisions to the Prioritization of the Review of Original ANDAs, Amendments, and Supplements MAPP (October 2022, November 2017, June 2017)
- Post-Complete Response Letter Clarification Teleconferences Between FDA and ANDA Applicants Under GDUFA Revised Final Guidance (October 2022)
- Communicating ANDA Review Status Updates with Industry MAPP (October 2022)
- A public docket to solicit comments on Appendix A of FDA’s July 2018 Guidance Entitled ANDA Submissions – Amendments to Abbreviated New Drug Applications Under GDUFA (August 2022)
- Draft Guidance for Industry: Evaluation of Therapeutic Equivalence (July 2022)
- List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic (Updated June 2022, December 2021 (added OTC products), June 2021, December 2020, June 2020, December 2019, June 2019, December 2018, June 2018, December 2017; originally published June 2017)
- Final Guidance for Industry: Good ANDA Submission Practices (January 2022)
- Draft Guidance for Industry: Revising ANDA Labeling Following Revision of the RLD Labeling (January 2022)
- Guidance for Industry: Cover Letter Attachments for Controlled Correspondences and ANDA Submissions (December 2021)
- Guidance for Industry: Controlled Correspondence Related to Generic Drug Development (December 2020)
- Guidance for Industry: Referencing Approved Drug Products in Abbreviated New Drug Application (ANDA) Submissions (November 2020)
- Draft guidance for Industry: Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe (September 2020)
- Final guidance for Industry: ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs (September 2020)
- Draft Guidance for Industry “Transdermal and Topical Delivery Systems – Product Development and Quality Considerations” (November 2019)
- 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)
- 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: 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)
- Post-Complete Response Letter Clarification Teleconferences Between FDA and ANDA Applicants Under GDUFA Revised Final Guidance (October 2022)
- Communicating ANDA Review Status Updates with Industry MAPP (October 2022)
- 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)
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.
- Draft Guidance for Industry: Sameness Evaluations in an ANDA – Active Ingredients (November 2022)
- Draft Guidance for Industry: Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs (October 2022)
- Draft Guidance for Industry: IVRT Studies for Topical Drug Products Submitted in ANDAs (October 2022)
- Draft Guidance for Industry: IVPT Studies for Topical Drug Products Submitted in ANDAs (October 2022)
- Draft Guidance for Industry: Topical Dermatologic Corticosteroids: In Vivo Bioequivalence (October 2022)
- Guidance for Industry: Formal Meetings between FDA and ANDA Applicants of Complex Products under GDUFA (November 2020)
- Manual of Policies and Procedures (MAPP): Evaluating Requests for and Conducting Product Development and Pre-Submission Pre-ANDA Meetings (October 2022)
- Draft Guidance for Industry: How To Obtain a Covered Product Authorization (September 2022)
- Manual of Policies and Procedures (MAPP): Classifying Approved New Drug Products and Drug-Device Combination Products as Complex Products for Generic Drug Development Purposes (April 2022)
- Draft Guidance for Industry: Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use (April 2022)
- Guidance for Industry: Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA (August 2021)
- Guidance for Industry: ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin (May 2021)
- Draft guidance for industry, Orange Book Questions and Answers, which is intended to assist prospective and current drug product applicants and approved application holders in effectively using the Orange Book. (May 2020)
- A public docket to solicit comments on how stakeholders and the public use the Orange Book and whether and how it can be improved. (May 2020)
- A public docket to solicit comments on the listing of patent information in the Orange Book. (May 2020)
- Public Workshop: Complex Generic Drug Product Development (September 2019)
- Launched website with information on Upcoming Product-Specific Guidances for Complex Generic Drug Product Development (April 2019)
- Revised Draft Guidance for Industry “Assessing Adhesion With Transdermal and Topical Delivery Systems for Abbreviated New Drug Applications” (October 2018)
- Draft Guidance for Industry “Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for Abbreviated New Drug Applications” (October 2018)
- FDA/DIA Regulatory Science Public Workshop: Complex Generic Drug-Device Combination Products (October 2018)
- Regulatory Science Public Workshop: Complex Generic Drug Product Development (September 2018)
- Regulatory Science Public Meeting: FY 2018 Generic Drug Regulatory Science Initiatives (May 2018)
- Regulatory Science Public Workshop: New Insights for Product Development and Bioequivalence Assessments of Generic Orally Inhaled and Nasal Drug Products (January 2018)
- Final Guidance for Industry: General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products (November 2017)
- Regulatory Science Public Workshop: Topical Dermatological Generic Drug Products (October 2017)
- Draft Guidance for Industry: Determining Whether to Submit an ANDA or a 505(b)(2) Application (October 2017)
- Regulatory Science Public Workshop: Demonstrating Equivalence of Generic Complex Drug Substances and Formulations (October 2017)
- Regulatory Science Public Workshop: Leveraging Quantitative Methods and Modeling to Modernize Generic Drug Development (October 2017)
- Draft Guidance for Industry: ANDAs for Certain Highly Purified Synthetic Peptide Drug Products that Refer to Listed Drugs of rDNA Origin (October 2017)
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.
- Final Guidance for Industry “Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act” (September 2019; Revised Draft published October 2018)
- Manual of Policies and Procedures (MAPP): Development of a Single, Shared System (SSS) Risk Evaluation and Mitigation Strategy (REMS) or a Separate REMS with Elements to Assure Safe Use (ETASU): Responsibilities and Procedures (February 2019)
- Draft Guidance for Industry: Development of a Shared System REMS (June 2018)
- Draft Guidance for Industry: Waivers of the Single, Shared System REMS Requirement (June 2018)
- Draft Guidance for Industry: Use of a Drug Master File for Shared System REMS Submissions (November 2017)
- Public Meeting: Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access (July 2017)
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.
- Complex Generics News
- HHS: Drug Pricing
- Advancing Patient Care Through Competition
- Capturing the Benefit of Competition for Patients
- Statement from FDA Commissioner Scott Gottlieb, M.D. on new steps to facilitate efficient generic drug review to enhance competition, promote access and lower drug prices
- Reducing the Hurdles for Complex Generic Drug Development
- FDA Tackles Drug Competition to Improve Patient Access
- FDA Working to Lift Barriers to Generic Drug Competition