Regulatory exclusivities consist of a period of time during which the Food and Drug Administration (FDA) protects an approved drug from competition in the marketplace. 75-717 (as amended), and Public Health Service Act, P. L. 78-410 (as amended), require the FDA to enforce 16 different regulatory exclusivities:
Twelve-Year Biologics Exclusivity, Ten-Year Transitional Exclusivity, Seven-Year Orphan Drug Exclusivity, Five-Year New Chemical Entity Exclusivity, Five-Year Enantiomer Exclusivity, Five-Year Qualifying Infectious (QI) Disease Product Exclusivity, Five-Year QI Act Antibiotic Exclusivity, Four-Year Biologics Exclusivity, Three-Year QI Act Antibiotic Exclusivity, Three-Year Clinical Investigation Exclusivity for an Original NDA, Three-Year Clinical Investigation Exclusivity for a Supplemental NDA, Two-Year Transitional Exclusivity, One-Year Interchangeable Biologics Exclusivity, Six-Month Pediatric Exclusivity, 180-Day Generic Exclusivity, and 180-Day Competitive Generic Therapy Exclusivity. To address this concern, the FDA Reauthorization Act of 2017, P.L. 115-52 , established a 180-day "competitive generic therapy" exclusivity period in circumstances of "inadequate generic competition." Proposed Reforms in the 115th Congress

Legislation introduced in the 115 th Congress would modify the current system of regulatory exclusivities. Duration of Protection

The Improving Access to Affordable Prescription Drugs Act, introduced as both H.R. 1776 and S. 771 , would modify the NCE exclusivity period. 1776 and S. 771 would instead allow the FDA to accept a generic drug application for the brand-name product three years after the brand-name product was approved. However, under this proposed legislation, the agency may not approve the ANDA until five years have passed since the brand-name product's approval date. This legislation would also reduce the regulatory exclusivity period for biologics from 12 to 7 years. 1776 and S. 771 would also limit the award of the three-year clinical investigation exclusivity to drugs that show "a significant clinical benefit over existing therapies manufactured by the applicant in the 5-year period preceding the submission of the application." Termination of Regulatory Exclusivities

H.R. 1776 and S. 771 would also call for the termination of a regulatory exclusivity if its proprietor engages in one of certain specified activities, including adulteration, misbranding, illegally marketing a drug, making false statements to the FDA, or entering into an anticompetitive settlement of patent infringement litigation. Abuse-Deterrent Opioids

The Abuse-Deterrent Opioids Plan for Tomorrow Act of 2017, H.R. 2025 , would limit the scope of the three-year clinical investigation exclusivity with respect to section 505(b)(2) applications that relate to abuse-deterrent opioids. 2025 would add the following language to the Federal Food, Drug, and Cosmetic Act:
A drug for which [a section 505(b)(2)] application ... is submitted shall not be considered ineligible for approval under this subsection on the basis that its labeling includes information describing the abuse-deterrent properties of the drug ... that otherwise would be blocked by [three-year clinical investigation] exclusivity ... if—
(I) the investigation or investigations relied upon by the applicant for approval of the labeling information were conducted by or for the applicant or the applicant has obtained a right of reference or use from the person by or for whom the investigation or investigations were conducted; and
(II) the drug has meaningful technological differences compared to the drug otherwise protected by exclusivity.... Orphan Drugs

The Orphan Products Extension Now Accelerating Cures and Treatments Act (OPEN ACT) of 2017, S. 1509 , would build upon the incentive structure of the Orphan Drug Act. That statute would require the FDA to extend by six months each existing exclusivity period for an approved drug or biological product when the product is additionally approved to prevent, diagnose, or treat a new indication that is a rare disease or condition. S. 1509 would clarify that the orphan drug exclusivity also does not bar the FDA from approving a new, clinically superior drug with the same active ingredient that will be marketed for treatment of the same disease or condition.
Regulatory exclusivities provide incentives for pharmaceutical innovation in the United States. Overseen by the Food and Drug Administration (FDA), regulatory exclusivities are alternatively known as marketing exclusivities, data exclusivities, or data protection. Each of the distinct regulatory exclusivities establishes a period of time during which the FDA affords an approved drug protection from competing applications for marketing approval.
Between them, the Federal Food, Drug, and Cosmetic Act, P.L. 75-717 (as amended), and the Public Health Service Act, P. L. 78-410 (as amended), require the FDA to enforce 16 different regulatory exclusivities. They include exclusivity terms of 12 years for biologics, 7 years for orphan drugs, 5 years for drugs that qualify as a new chemical entity (NCE), 3 years for certain clinical investigations, and 180 days for generic drug companies that challenge relevant patents under certain conditions. Other, more specialized regulatory exclusivities pertain to antibiotics, enantiomers, and qualifying infectious disease products.
Legislation introduced in the 115th Congress would modify the current system of regulatory exclusivities. One bill, the FDA Reauthorization Act of 2017, was signed into law on August 18, 2017, as P.L. 115-52. That legislation establishes a wholly new 180-day "competitive generic therapy" exclusivity period in order to address circumstances of "inadequate generic competition."
Other legislation has been introduced but not enacted. The Improving Access to Affordable Prescription Drugs Act, introduced as both H.R. 1776 and S. 771, would modify the NCE exclusivity period to allow FDA to accept a generic drug application for the brand-name product after three years rather than five. However, the agency may not approve the generic application until five years have passed since the brand-name product's approval date. This legislation would also limit the award of the three-year clinical investigation exclusivity to drugs that show significant clinical benefit over existing therapies manufactured by the applicant in the five-year period prior to the application.
H.R. 1776 and S. 771 would also reduce the regulatory exclusivity period for biologics from 12 to 7 years. The two bills would also call for the termination of a regulatory exclusivity if its proprietor engages in one of certain specified activities, including adulteration, misbranding, illegally marketing a drug, or making false statements to the FDA. In addition, the Abuse-Deterrent Opioids Plan for Tomorrow Act of 2017, H.R. 2025, would limit the scope of regulatory exclusivities with respect to so-called "505(b)(2) applications" that relate to abuse-resistant opioids.
Finally, the Orphan Products Extension Now Accelerating Cures and Treatments Act (OPEN ACT) of 2017, S. 1509, would require the FDA to extend by six months the exclusivity period for an approved drug or biological product when the product is additionally approved to prevent, diagnose, or treat a new indication that is a rare disease or condition. S. 1509 and another bill, S. 934, the FDA Reauthorization Act, would also clarify that the orphan drug exclusivity does not bar the FDA from approving a new, clinically superior drug with the same active ingredient that will be marketed for treatment of the same disease or condition. As well, the OPEN ACT would extend a "labelling carve out" to section 505(b)(2) applications with respect to pediatric uses.