H.R. 6241: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2016

114th Congress · introduced 2016-09-28 · Health · Latest: Referred to the Committee on Energy and Commerce, and in addition to the Committee on Rules, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.

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Follow this bill, step by step

Where it came from: introduced 2016-09-28 · official record
Who proposed it: Rep. DeSantis, Ron [R-FL-6] · what a sponsor is
What happened next: no floor votes in our records yet. Why?
Where it stands now: Referred to the Committee on Energy and Commerce, and in addition to the Committee on Rules, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned. 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

Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2016

Plain summary

Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2016 This bill amends the Federal Food, Drug, and Cosmetic Act to establish a reciprocal marketing approval process that allows for the sale of a drug, biological product, or medical device that has not been approved by the Food and Drug Administration (FDA) if the product is approved for sale in another country. For a product to be granted reciprocal marketing approval, the product's sponsor must submit a request to the FDA that demonstrates: (1) the product may be sold in at least one country from a specified list of countries, (2) the FDA and listed countries have not withdrawn approval of the product because of safety or effectiveness concerns, and (3) there is a public health or unmet medical need for the product. The FDA may: (1) require postmarket studies of a product granted reciprocal marketing approval, or (2) decline to approve a product that is not safe and effective. The FDA must grant or decline reciprocal marketing approval not later than 30 days after receiving a request. During that period, the FDA and product sponsor must negotiate and finalize product labeling and, for a medical device, classify the device. Congress may pass a joint resolution to grant reciprocal marketing approval to a product that the FDA declines to approve through this process. User fees apply to requests for reciprocal marketing approval. The FDA must encourage the sponsors of potentially eligible products to request reciprocal marketing approval.

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

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

A “Nay” vote

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What does this mean? (plain words)

Official text

Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2016

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. DeSantis, Ron [R-FL-6] · 1 cosponsors

Cost estimate: No cost estimate published yet.

Cosponsors on this site

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).
Joint resolution: In Texas, the type of measure the Legislature uses to propose a constitutional amendment (marked HJR or SJR). The governor does not sign or veto it; the voters decide. In Congress a joint resolution can also be used like a bill. In Florida, a joint resolution passed by three-fifths of the members of each chamber puts a constitutional amendment on the ballot.

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-114hr6241.xml <https://www.govinfo.gov/bulkdata/BILLSTATUS/114/hr>

Record fed-us-cong114-hr6241 · catalog fed-us-congress-bills-cong114 · updated 2026-11-15 by psicol fed-bills-cong114