Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2019 or the BLOCKING Act of 2019
This bill modifies provisions related to market exclusivity for a generic drug.
Currently, the Food and Drug Administration (FDA) awards 180 days of exclusivity on the market to a first applicant to file a qualifying application for market approval of a generic drug. Generally, this exclusivity period begins upon a first applicant's commercial marketing of the drug.
The bill authorizes the FDA to approve a subsequent generic drug application prior to a first applicant's first date of commercial marketing if (1) the subsequent application is ready for full approval, (2) a first applicant's application has been pending for at least 30 months, and (3) the approval of a first applicant's application is not precluded by patent infringement claims asserted against that first applicant.
| Action Date | Type | Text | Source |
|---|---|---|---|
| 2019-05-02 | Calendars | Placed on the Union Calendar, Calendar No. 24. | House floor actions |
| 2019-05-02 | Committee | Reported by the Committee on Energy and Commerce. H. Rept. 116-46. | House floor actions |
| 2019-04-03 | Committee | Ordered to be Reported by Voice Vote. | House committee actions |
| 2019-04-03 | Committee | Committee Consideration and Mark-up Session Held. | House committee actions |
| 2019-03-27 | Committee | Forwarded by Subcommittee to Full Committee by Voice Vote . | House committee actions |
| 2019-03-27 | Committee | Subcommittee Consideration and Mark-up Session Held. | House committee actions |
| 2019-02-02 | Committee | Referred to the Subcommittee on Health. | House committee actions |
| 2019-01-31 | IntroReferral | Referred to the House Committee on Energy and Commerce. | House floor actions |
| 2019-01-31 | IntroReferral | Introduced in House | Library of Congress |