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          FDA Drug Competition Action PlanGuidance, 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
	
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    PrintBringing 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.

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 October 2023, FDA revised section 5200.14 of the Manual of Policies and Procedures, “Filing Review of Abbreviated New Drug Applications (ANDAs),” to reflect the current ANDA filing review process. This MAPP, which was first published in 2017, outlines the policies and procedures for the conduct of a filing review of an ANDA.
	In June 2023, FDA published the guidance for industry, “Cover Letter Attachments for Controlled Correspondences and ANDA Submissions,” which is intended to assist prospective applicants, applicants, and holders of ANDAs with optional attachments that can be used when preparing cover letters that accompany controlled correspondence to the FDA, as well as original ANDAs, amendments to ANDAs, and supplements to approved ANDAs submitted to FDA.
	In April 2023, FDA revised two draft guidances for industry related to the design and conduct of studies for evaluating transdermal and topical delivery systems (TDS) submitted in supported of abbreviated new drug applications (ANDAs). These guidances are “Assessing Adhesion with Transdermal and Topical Delivery Systems for ANDAs” and “Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs.”Additional Resources

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

FDA-USPTO Collaboration Initiatives
	Complex Generics News

                                                                                  Content current as of:
      01/26/2024
              
              
Regulated Product(s)
		 Drugs
			  			     			  						              
			
			
			
			
						  Generic DrugsTopic(s)
			  Compliance
				    				       				    					
				  
				    
				  Pharmaceutical QualityGuidance, Compliance, & Regulatory Information

          
                        Good Review Practices | GRPs


                        Guidances | Drugs
          Electronic Drug Registration and Listing System (eDRLS)
          CDER FOIA Electronic Reading Room
          CDER International Program
          Enforcement Activities | FDA
          Human Drug Compounding
          Human Drug Exports
          Human Drug Imports
          Laws, Acts, and Rules
          Postmarketing Requirements and Commitments: Introduction
          Surveillance: Post Drug-Approval Activities
 
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