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HEAL Act

Introduced: February 12, 2015 Introduced by: DeLauro, Rosa L. Democratic · Connecticut See on congress.gov

Everywhere this bill has been 3 steps

Introduced

In committee

Reported out

Passed House

Passed Senate

To President

Became law

Feb 13, 2015

Referred to the Subcommittee on Health.

Feb 12, 2015

Referred to the House Committee on Energy and Commerce.

Feb 12, 2015

Introduced in House

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Plain-English summary Congressional Research Service

Helping Effective Antibiotics Last Act of 2015 or the HEAL Act

This bill amends the Federal Food, Drug, and Cosmetic Act to allow the Food and Drug Administration (FDA) to approve an antibacterial drug or biological product that is intended to treat a serious or life-threatening condition only for treating a well-defined population of patients. To be approved, the antibacterial product must produce superior outcomes over available therapies in the well-defined patient population.

A product approved by this pathway must include in its prescribing information the population of patients expected to benefit from using the product and the method for identifying members of that population. The FDA must require each product to have a risk evaluation and mitigation strategy.

The Centers for Disease Control and Prevention must monitor changes to bacterial drug resistance and changes to patient outcomes caused by bacterial drug resistance.

Upon approval of antibacterial products, the FDA must identify susceptibility test interpretive criteria (the drug concentrations where a type of bacteria is categorized as susceptible, intermediate, or resistant) and update the criteria as needed based upon evidence of changes in patient outcomes.

To be eligible for an exclusivity period extension, a qualified infectious disease product must be demonstrated to produce superior outcomes over available therapies.

The FDA must issue guidance on the development of target product profiles for antibacterial drugs.

What's happening now February 13, 2015

Referred to the Subcommittee on Health.

Bill text 1 version