Senate Bill 340
116th Congress(2019-2020)
A bill to promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products.
Introduced
Introduced in Senate on Feb 5, 2019
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
340
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
Creating and Restoring Equal Access to Equivalent Samples Act of 2019 or the CREATES Act of 2019
This bill generally allows the developer of a drug or biological product, such as a generic or biosimilar version of a drug, to bring a civil action against the license holder of an approved medication if the holder refuses to make available sufficient quantities of the approved medication for the developer's testing. The bill also establishes affirmative defenses to such a civil action.
In addition, the bill authorizes drug manufacturers seeking Food and Drug Administration approval for a generic drug to use alternative methods to develop elements assure safe use of a drug.February 6, 2019
02/06/2019
Read the second time. Placed on Senate Legislative Calendar under General Orders. Calendar No. 22.
02/05/2019
Introduced in the Senate. Read the first time. Placed on Senate Legislative Calendar under Read the First Time. (Sponsor introductory remarks on measure: CR S868-869)
02/05/2019
Introduced in Senate
Public Record
Record Updated
Jan 14, 2022 4:32:21 PM