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- In June 2020, FDA published the draft guidance for industry, Orange Book Questions and Answers, and two public dockets on the use of the Orange Book and patent information listings:
- 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.
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: Competitive Generic Therapies (March 2020)
- List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic (Updated December 2019, June 2019, December 2018, June 2018, December 2017; originally published June 2017)
- 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)
- 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)
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, 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.
- A public docket to solicit comments on how stakeholders and the public use the Orange Book and whether and how it can be improved.
- A public docket to solicit comments on the listing of patent information in the Orange Book.
- Public Workshop: Complex Generic Drug Product Development (September 2019)
- Manual of Policies and Procedures (MAPP): Evaluating Requests for and Conducting Product Development and Pre-Submission Pre-ANDA Meetings (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: Formal Meetings between FDA and ANDA Applicants of Complex Products under GDUFA (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.
- Updates to the Reference Listed Drug (RLD) Access Inquiries Webpage (September 2019, February 2019; originally published May 2018)
- 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)
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.
- 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