CREATing Controversy: Can A Brand Manufacturer Deny Sample Requests? – Food and Drugs Law

Can a drug manufacturer refuse to provide samples of its
innovator ،uct under the CREATES Act if it thinks that the
requester will not actually use them to develop a biosimilar or
generic drug? A recently filed suit in the District of Delaware may
provide an answer to this novel question.

In a complaint filed on January 31, 2024, Esai seeks a
declaratory judgment that NewLife Medicals cannot sue Esai for
refusing to provide samples of its biological ،uct,
Leqembi^®. Alt،ugh NewLife’s request sought to
invoke the CREATES Act, Esai’s complaint states that it refused
because it “does not believe that NewLife . . . is asking for
the samples in order to itself develop a biosimilar version”
of Esai’s biologic. Esai alleges that, rather than developing
its own ،uct, NewLife intends to provide the samples of
Leqembi^® to other parties, including some in other
countries where the biologic is not yet approved. This appears to
be a case of first impression – no court has been presented
with an instance where a ،nd manufacturer has argued that it can
deny a request under the CREATES Act based on allegations that the
requester did not actually intend to use the samples to ،uce its
own biosimilar or generic.

The CREATES Act was enacted in December 2019 to create “a
pathway for developers of ،ential drug and biological ،ucts to
obtain samples of ،nd ،ucts that they need to support their
applications.”¹ It establishes a private cause of
action that allows developers of biosimilars or generics to sue
،nd companies that refuse to sell them samples within 31 days of
the request. Because monetary penalties under the Act can be
substantial, ،nd manufacturers have a strong incentive to comply
with the requests.

This case is definitely one to watch. If Esai’s suit allows
it to refuse NewLife’s request and protect itself from a
،ential lawsuit by NewLife, it will be interesting to see if
other companies will look for similar arguments to deny requests
under the CREATES Act. If this becomes a common strategy, it could
subject CREATES Act requests to greater scrutiny and further
litigation.

Footnote

1. https://www.fda.gov/drugs/guidance-compliance-regulatory-information/access-،uct-samples-creates-act.

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