General Law Committee
JOINT FAVORABLE REPORT
Bill No.: SB-262
AN ACT REQUIRING MANUFACTURERS OF BRAND NAME PRESCRIPTION
DRUGS TO PROVIDE SAMPLES OF SUCH DRUGS TO MANUFACTURERS
Title: OF GENERIC PRESCRIPTION DRUGS.
Vote Date: 2/16/2021
Vote Action: Joint Favorable
PH Date: 1/28/2021
File No.: 12
Disclaimer: The following JOINT FAVORABLE Report is prepared for the benefit of the
members of the General Assembly, solely for purposes of information, summarization and
explanation and does not represent the intent of the General Assembly or either chamber
thereof for any purpose.
SPONSORS OF BILL:
General Law Committee
REASONS FOR BILL:
To define "eligible product developer" as a person that plans to seek drug or biological
product approval under provisions of the FDCA or PHSA. Requires state-registered drug
manufacturers and wholesalers to make drugs distributed in the state available for sale to
these developers without restrictions on the reference sample sales.
RESPONSE FROM ADMINISTRATION/AGENCY:
None
NATURE AND SOURCES OF SUPPORT:
Senator Martin M. Looney supports the drug. The bill requires brand name pharmaceutical
manufactures in the state to comply with federal law and make their samples available to the
generic and biosimilar developers. The bill would allow the Attorney General to bring legal
action against those manufacturers that do not comply. The bill does not require the brand
manufacture provide the samples at no cost but at a fair market value.
NATURE AND SOURCES OF OPPOSITION:
Biotechnology Innovative Organization opposes the bill. As the largest trade association
representing biotechnology companies this legislation would require a manufacturer or
wholesaler of prescription drugs to provide samples. The bill would pose potential legal
complications under the Prescription Drug Marketing (PDMA).
Pharmaceutical Research and Manufacturers of America opposes the bill The bill would
require manufactures of branded medicines to provide products to another drug or geologic
manufactures which is duplicative of and in conflict with recently enacted federal laws.
Because of existing statutory and regulatory federal framework state law is unnecessary.
Reported by: Pamela Bianca Date: March 1, 2021
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