The Congress recently introduced a bill on the COMBAT Act (Curb Opioid Misuse By Advancing Technology Act of 2016) to incentivize the development of abuse-deterrent opioids by amending the Federal Food, Drug, and Cosmetic Act to extend the exclusivity period for certain drug products developed or labeled so as to reduce drug abuse, and for other purposes.
Implications on Exclusivity to Certain New Drug Applications (NDAs) –
The COMBAT Act would amend Section 505(c)(3)(E) of the Federal Food, Drug, and Cosmetic Act i.e. 21 U.S.C. 355(c)(3)(E) by adding at the end the following:
(vi) With respect to an application described in clause (iii) or a supplement to an application described in clause (iv), if such application or supplement is approved on or after the date of enactment of the Curb Opioid Misuse By Advancing Technology Act of 2016, the 3-year period specified in each such clause shall be extended for an additional period of 12 months if the person submitting such application or supplement provides documentation to the Secretary demonstrating that the drug that is the subject of the application or supplement—
(I) is approved, in whole or in part, on the basis of one or more new clinical abuse potential studies; and
(II) is approved with labeling that characterizes the abuse-deterrent properties of the drug product.
Implications on Exclusivity to Certain Abbreviated New Drug Applications (ANDAs) –
The COMBAT Act would amend Section 505(j)(5) of the Federal Food, Drug, and Cosmetic Act i.e. 21 U.S.C. 355(j)(5) as following
(1) in subparagraph (B), by adding at the end the following:
''(v) With respect to an abbreviated application described in clause (iv), if such application is approved on or after the date of enactment of the Curb Opioid Misuse By Advancing Technology Act of 2016, the 180-day period specified in such clause shall be extended for an additional period of 60 days if the first applicant submitting the abbreviated application provides documentation to the Secretary demonstrating that the listed drug referred to paragraph (2)(A)(i) and referenced in the abbreviated application—
(I) is approved, in whole or in part, on the basis of one or more new clinical abuse potential studies; and
(II) is approved with labeling that characterizes the abuse-deterrent properties of the drug product.
(2) in subparagraph (F), by adding at the end the following:
''(vi) With respect to an application described in clause (iii) or a supplement to an application described in clause (iv), if such application or supplement is approved on or after the date of enactment of the Curb Opioid Misuse By Advancing Technology Act of 2016, the 3-year period specified in each such clause shall be extended for an additional period of 12 months if the person submitting such application or supplement provides documentation to the Secretary demonstrating that the drug that is the subject of the application or supplement—
(I) is approved, in whole or in part, on the basis of one or more new clinical abuse potential studies; and
(II) is approved with labeling that characterizes the abuse-deterrent properties of that drug product.
Access copy of the bill here
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