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OLR Bill Analysis
sSB 262
AN ACT REQUIRING MANUFACTURERS OF BRAND NAME
PRESCRIPTION DRUGS TO PROVIDE SAMPLES OF SUCH
DRUGS TO MANUFACTURERS OF GENERIC PRESCRIPTION
DRUGS.
SUMMARY
This bill requires state-registered drug manufacturers and
wholesalers to make a drug distributed in the state available for sale to
an “eligible product developer” for certain purposes at no more than
“wholesale acquisition cost.” The bill defines an “eligible product
developer” as a person that plans to seek drug or biological product
approval under certain provisions of the federal Food, Drug, and
Cosmetic Act (FDCA) or federal Public Health Service Act (PHSA).
Under the bill, drug manufacturers and wholesalers must make
available to these developers the drugs that they manufacture or
develop for the purpose of conducting the tests required to support
such approval. Manufacturers and wholesalers cannot impose
restrictions on these reference sample sales that are inconsistent with
FDCA § 505-1(f)(8) and block or delay an eligible product developer’s
application for drug approval. (For information on these FDCA and
PHSA provisions, see BACKGROUND.)
Eligible product developers that obtain drugs at or below wholesale
acquisition cost must, when subsequently selling the product that they
develop, charge Connecticut consumers the same price or less.
Manufacturers, wholesalers, or eligible product developers that
violate the bill’s provisions are subject to enforcement action under the
Connecticut Unfair Trade Practice s Act (CUTPA) (see
BACKGROUND). Federal law creates a similar right of action for
generic developers that cannot obtain reference samples (see
BACKGROUND). 2021SB-00262-R00-BA.DOCX
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Lastly, the bill specifies that manufacturers and wholesalers that
make products available to developers under these provisions are not
liable for injuries caused by products they did not manufacture or sell.
EFFECTIVE DATE: October 1, 2021
DUTY TO MAKE AVAILAB LE
Under the bill, drug manufacturers and wholesalers must make
drugs available to an eligible product developer for the purpose of
conducting the tests required to support an application or license
under FDCA §§ 505(b) or (j) or PHSA § 351 at no more than the
“wholesale acquisition cost.” The bill defines this as the
manufacturer’s list price for a brand-name or generic drug, per person,
year, or course of treatment when sold to wholesalers or direct
purchasers in the United States, excluding discounts or rebates. The
cost calculation is based on the most recent month for which
information is available.
LIABILITY
Under the bill, manufacturers and wholesalers that make drugs
available to eligible product developers under the bill’s provisions are
not liable for injuries allegedly caused by the developer’s failure to
include adequate safety warning labels or by product design defects, if
the product was not manufactured or sold by such manufacturer or
wholesaler.
BACKGROUND
Connecticut Unfair Trade Practices Act
The law prohibits businesses from engaging in unfair and deceptive
acts or practices. CUTPA allows the Department of Consumer
Protection commissioner to issue regulations defining what constitutes
an unfair trade practice, investigate complaints, issue cease and desist
orders, order restitution in cases involving less than $10,000, enter into
consent agreements, ask the attorney general to seek injunctive relief,
and accept voluntary statements of compliance. It also allows
individuals to sue. Courts may issue restraining orders; award actual
and punitive damages, costs, and reasonable attorney’s fees; and 2021SB-00262-R00-BA.DOCX
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impose civil penalties of up to $5,000 for willful violations and $25,000
for violation of a restraining order.
FDCA § 505(b) & (j) and PHSA § 351
Sections 505(b) and (j) of FDCA establish abbreviated approval
pathways for generic drugs (e.g., by allowing applicants to rely, in
part, on data for previously approved drugs). The traditional pathway
for new drug approval is also established in § 505(b).
Like FDCA §§ 505(b) and (j), PHSA § 351 includes an abbreviated
approval pathway for biologics that are biosimilar to a previously
approved biological product.
FDCA § 505-1(f)(8)
Section 505-1(f)(8) prohibits owners of previously approved drugs
from imposing certain restrictions on a drug’s distribution to block or
delay an application submitted pursuant to the abbreviated approval
pathways established in FDCA §§ 505(b) and (j).
Federal Private Right of Action to Obtain Reference Samples
In December 2019, a new federal law (P.L. 116-94, § 610) allowed
generic drug developers to bring lawsuits in federal court if they
cannot obtain brand product (reference) samples needed to support
the generic drug application at a price no higher than the drug’s
wholesale acquisition cost, as defined by federal law.
COMMITTEE ACTION
General Law Committee
Joint Favorable
Yea 16 Nay 3 (02/16/2021)