HR 938 116th Congress House Health Competition and antitrust Drug safety, medical device, and laboratory regulation Health care costs and insurance Health care coverage and access Licensing and registrations Marketing and advertising Prescription drugs

BLOCKING Act of 2019

Introduced: January 31, 2019 See on congress.gov

Everywhere this bill has been 9 steps

Introduced

In committee

Reported out

Passed House

Passed Senate

To President

Became law

May 2, 2019

Placed on the Union Calendar, Calendar No. 24.

May 2, 2019

Reported by the Committee on Energy and Commerce. H. Rept. 116-46.

Apr 3, 2019

Ordered to be Reported by Voice Vote.

Apr 3, 2019

Committee Consideration and Mark-up Session Held.

Mar 27, 2019

Forwarded by Subcommittee to Full Committee by Voice Vote .

Mar 27, 2019

Subcommittee Consideration and Mark-up Session Held.

Feb 2, 2019

Referred to the Subcommittee on Health.

Jan 31, 2019

Referred to the House Committee on Energy and Commerce.

Jan 31, 2019

Introduced in House

Plain-English summary Congressional Research Service

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.

What's happening now May 2, 2019

Placed on the Union Calendar, Calendar No. 24.

Committees of jurisdiction 2