H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act

114th Congress · introduced 2015-02-02 · Crime and Law Enforcement · Latest: Became Public Law No: 114-89.

federal

Follow this bill, step by step

Where it came from: introduced 2015-02-02 · official record
Who proposed it: Rep. Pitts, Joseph R. [R-PA-16] · what a sponsor is
What happened next: no floor votes in our records yet. Why?
Where it stands now: Became Public Law No: 114-89. (final step reached)
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

Improving Regulatory Transparency for New Medical Therapies Act

Plain summary

(This measure has not been amended since it was passed by the Senate on October 26, 2015. The summary of that version is repeated here.) Improving Regulatory Transparency for New Medical Therapies Act (Sec. 2) This bill amends the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to delay the effective date of approval of a drug, biological product, or animal drug for which the Food and Drug Administration (FDA) recommends controls under the Controlled Substances Act until the Department of Justice (DOJ) issues a final interim rule for the drug. This delay also applies to conditional approval and indexing of animal drugs. This bill amends the Controlled Substances Act to require the DOJ to issue a final interim rule for a drug product recommended for controls by the FDA not later than 90 days after DOJ receives a recommendation for controls or the FDA approves the drug. The final interim rule is effective immediately. For purposes of submitting an application to extend a patent, a drug product recommended for controls is considered to be approved and have permission for commercial marketing and use on the date of FDA approval or the date an interim final rule is issued, whichever is later. (Sec. 3) Timelines are established for DOJ to either register an applicant to manufacture a controlled substance for a clinical trial or serve an order to show cause upon the applicant. (Sec. 4) This bill amends the Controlled Substances Import and Export Act to allow exported controlled substances to be re-exported within the European Economic Area.

Congressional Research Service summary (Public Law), quoted unchanged (nonpartisan). Read the source.

What a vote does

A “Yea” vote

If it passes both chambers and is signed, it becomes law.

A “Nay” vote

If it is not passed, current law stays as it is.

PSI Sci description of the legislative step (not an opinion).

What does this mean? (plain words)

Official text

Improving Regulatory Transparency for New Medical Therapies Act

Source: Congressional Research Service summary (Public Law)

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The strongest published arguments

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Alternatives

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

Officials and money

Sponsor: Rep. Pitts, Joseph R. [R-PA-16] · 3 cosponsors

Cost estimate: CBO cost estimate: H.R. 639, Improving Regulatory Transparency for New Medical Therapies Act (2015-03-17)

Cosponsors on this site

Frank Pallone, Jr. (D-NJ)

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 (2)

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).
Rulemaking: The process agencies use to write regulations that carry out laws passed by Congress or a legislature. Usually an agency publishes a proposed rule, takes public comments, then publishes a final rule.

Plain meanings written from linked sources. All words.

Sources

Congressional Research Service summary (Public Law)
Congress.gov
Data: GovInfo BILLSTATUS bulk data (Library of Congress), BILLSTATUS-114hr639.xml <https://www.govinfo.gov/bulkdata/BILLSTATUS/114/hr>

Record fed-us-cong114-hr639 · catalog fed-us-congress-bills-cong114 · updated 2026-11-15 by psicol fed-bills-cong114