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Bill116th CongressFiled Jan 31, 2019Health
H.R. 938

BLOCKING Act of 2019

Bill journey · stage 2 of 5

Under committee review

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What it doesSummary reported to house (May 2, 2019)

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 just happenedMay 2, 2019

Placed on the Union Calendar, Calendar No. 24.

Who’s behind it

Rep. Schrader, Kurt [D-OR-5](D-OR)Sponsor
16 cosponsors13 D3 R
Read on Congress.gov
16cosponsors1committees11actions3related bills7subjects
  1. May 2, 2019CalendarsH12410

    Placed on the Union Calendar, Calendar No. 24.

  2. May 2, 2019CommitteeH12200

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

    Energy and Commerce Committee
  3. May 2, 2019Committee5000

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

    Energy and Commerce Committee
  4. Apr 3, 2019Committee

    Ordered to be Reported by Voice Vote.

    Energy and Commerce Committee
  5. Apr 3, 2019Committee

    Committee Consideration and Mark-up Session Held.

    Energy and Commerce Committee
  6. Mar 27, 2019Committee

    Forwarded by Subcommittee to Full Committee by Voice Vote .

    Health Subcommittee
  7. Mar 27, 2019Committee

    Subcommittee Consideration and Mark-up Session Held.

    Health Subcommittee
  8. Feb 2, 2019Committee

    Referred to the Subcommittee on Health.

    Health Subcommittee
  9. Jan 31, 2019IntroReferralH11100

    Referred to the House Committee on Energy and Commerce.

    Energy and Commerce Committee
  10. Jan 31, 2019IntroReferralIntro-H

    Introduced in House

  11. Jan 31, 2019IntroReferral1000

    Introduced in House

Reported to HouseMay 2, 20197

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.

Introduced in HouseJan 31, 2019

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.

BLOCKING Act of 2019 — Informed