Senate Bill 3271
116th Congress(2019-2020)
Fairness in Orphan Drug Exclusivity Act
Introduced
Introduced in Senate on Feb 11, 2020
Origin Chamber
Senate
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
3271
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.
No Senate votes have been held for this bill.
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 must consider the sales of all drugs from the sponsor that are covered by the same orphan drug designation.
February 11, 2020
02/11/2020
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
02/11/2020
Introduced in Senate
Public Record
Record Updated
Feb 9, 2022 12:55:56 AM