To amend the Federal Food, Drug, and Cosmetic Act, with respect to eligibility for approval of a subsequent generic drug, to remove the barrier to that approval posed by the 180-day exclusivity period afforded to a first generic applicant that has not yet received final approval, and for other purposes.
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.
Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.
Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
Subcommittee Consideration and Mark-up Session Held.
Forwarded by Subcommittee to Full Committee by Voice Vote .
Committee Consideration and Mark-up Session Held.
Ordered to be Reported by Voice Vote.
Reported by the Committee on Energy and Commerce. H. Rept. 116-46.
Reported by the Committee on Energy and Commerce. H. Rept. 116-46.
Placed on the Union Calendar, Calendar No. 24.
checking server…
Ask anything about this bill. The AI reads the full text to answer.
Enter to send · Shift+Enter for new line