H.R. 1576: Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015

114th Congress · introduced 2015-03-24 · Health · Latest: Referred to the Subcommittee on Health.

federal

Follow this bill, step by step

Where it came from: introduced 2015-03-24 · official record
Who proposed it: Rep. Burgess, Michael C. [R-TX-26] · what a sponsor is
What happened next: no floor votes in our records yet. Why?
Where it stands now: Referred to the Subcommittee on Health. Not final yet: this can still change. We check for updates every day.
If it becomes law and spends money: follow the money to money laws, then agencies and contracts and grants.

What does this mean?

Official title

Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015

Plain summary

Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015 This bill requires the Government Accountability Office (GAO) to study whether generic versions of certain complex drugs or certain biological drugs face significantly different challenges in meeting the approval standards of the Food and Drug Administration (FDA) than generic versions of small-molecule drugs. (Complex drugs and biological drugs can be composed of large molecules that are more difficult to fully characterize than small molecules, so it can be more difficult to demonstrate that generic versions of these drugs are the same as the brand name versions.) If the GAO determines that these generic drugs face significantly different challenges, then the GAO must also determine: (1) the evidence that should be required to demonstrate that one of these generic drugs is sufficiently similar to the brand name drug in safety, composition, and activity; (2) whether the Federal Food, Drug, and Cosmetic Act should be amended to address the approval of these generic drugs; and (3) whether the FDA should develop a policy document on the evidence that is necessary to obtain approval of these generic drugs.

Congressional Research Service summary (Introduced in House), quoted unchanged (nonpartisan). Read the source.

What a vote does

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A “Nay” vote

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What does this mean? (plain words)

Official text

Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015

Source: Congressional Research Service summary (Introduced in House)

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How did my representative vote? · This bill's floor votes

Officials and money

Sponsor: Rep. Burgess, Michael C. [R-TX-26] · 7 cosponsors

Cost estimate: No cost estimate published yet.

Cosponsors on this site

Gus M. Bilirakis (R-FL), Richard Hudson (R-NC)

No linked floor roll calls in our collected records yet. This does not mean the bill has never had a vote. Check the official bill history.

Words on this page, explained (1)

Bill: A proposed law. It becomes law only if it passes the legislature and is signed by the president or governor (or a veto is overridden).

Plain meanings written from linked sources. All words.

Sources

Congressional Research Service summary (Introduced in House)
Congress.gov
Data: GovInfo BILLSTATUS bulk data (Library of Congress), BILLSTATUS-114hr1576.xml <https://www.govinfo.gov/bulkdata/BILLSTATUS/114/hr>

Record fed-us-cong114-hr1576 · catalog fed-us-congress-bills-cong114 · updated 2026-11-15 by psicol fed-bills-cong114