Bill Sponsor
House Bill 4712
116th Congress(2019-2020)
Fairness in Orphan Drug Exclusivity Act
Active
Active
Passed House on Nov 17, 2020
Overview
Text
Introduced
Oct 17, 2019
Latest Action
Nov 18, 2020
Origin Chamber
House
Type
Bill
Bill
The primary form of legislative measure used to propose law. Depending on the chamber of origin, bills begin with a designation of either H.R. or S. Joint resolution is another form of legislative measure used to propose law.
Bill Number
4712
Congress
116
Policy Area
Health
Health
Primary focus of measure is science or practice of the diagnosis, treatment, and prevention of disease; health services administration and funding, including such programs as Medicare and Medicaid; health personnel and medical education; drug use and safety; health care coverage and insurance; health facilities. Measures concerning controlled substances and drug trafficking may fall under Crime and Law Enforcement policy area.
Sponsorship by Party
Democrat
Pennsylvania
Democrat
New Jersey
Democrat
New York
Republican
West Virginia
House Votes (1)
Senate Votes (0)
checkPassed on November 17, 2020
Status
Passed
Type
Voice Vote
Voice Vote
A vote in which the presiding officer states the question, then asks those in favor and against to say "Yea" or "Nay," respectively, and announces the result according to his or her judgment. The names or numbers of senators voting on each side are not recorded.
Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote.(text: CR H5807)
Summary

Fairness in Orphan Drug Exclusivity Act

This bill limits which orphan drugs may be granted a market exclusivity period by the Food and Drug Administration (FDA). (Generally, an orphan drug is one that is not economically viable because of the rarity of the disease that it treats; the sponsor of an FDA-designated orphan drug may be granted various incentives, such as a seven-year period in which the FDA may not grant market approval to a different sponsor for the same drug to treat the same disease.)

Specifically, when determining whether to grant an exclusivity period to a drug that has orphan status due to low expected sales, the FDA shall consider the sales of all drugs from the sponsor that have the same core molecule or ion that is responsible for the drug's physiological or pharmacological action.

Text (4)
November 18, 2020
November 17, 2020
November 16, 2020
October 17, 2019
Actions (16)
11/18/2020
Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
11/17/2020
Motion to reconsider laid on the table Agreed to without objection.
11/17/2020
On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H5807)
11/17/2020
Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote.(text: CR H5807)
11/17/2020
DEBATE - The House proceeded with forty minutes of debate on H.R. 4712.
11/17/2020
Considered under suspension of the rules. (consideration: CR H5807-5809)
11/17/2020
Mr. Pallone moved to suspend the rules and pass the bill, as amended.
11/16/2020
Placed on the Union Calendar, Calendar No. 470.
11/16/2020
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 116-572.
07/15/2020
Ordered to be Reported (Amended) by Voice Vote.
07/15/2020
Committee Consideration and Mark-up Session Held.
03/11/2020
Forwarded by Subcommittee to Full Committee (Amended) by Voice Vote .
03/11/2020
Subcommittee Consideration and Mark-up Session Held.
10/18/2019
Referred to the Subcommittee on Health.
10/17/2019
Referred to the House Committee on Energy and Commerce.
10/17/2019
Introduced in House
Public Record
Record Updated
Jan 11, 2023 1:44:19 PM