Sept 23 (Reuters) - A federal judge on Tuesday refused
to block Maine from enforcing a new state law requiring
drugmakers to offer discounts on drugs dispensed by third-party
pharmacies that contract with hospitals and clinics serving
rural, low-income populations.
The ruling by U.S. Magistrate Judge John Nivison in Portland
marked the latest setback in the pharmaceutical industry's
efforts to challenge similar laws that about 20 states have
adopted to safeguard access to the federal 340B Drug Pricing
Program.
The judge declined to issue a preliminary injunction sought
by drugmakers Novartis and AbbVie ( ABBV ) that would prevent the Maine
Protect Health Care for Rural and Underserved Communities Act
from taking effect on Wednesday as scheduled.
The companies did not respond to a request for comment.
Democratic-led Maine's law, like its counterparts
nationally, was designed to ensure hospitals can use contract
pharmacies while participating in the federal 340B discount
program.
The program requires drugmakers to offer discounts on drugs
to hospitals and clinics serving low-income populations as a
condition to receive funds from government health insurance
programs like Medicare and Medicaid.
Many hospitals and clinics eligible for the 340B program
contract with outside pharmacies to dispense prescription drugs,
so that they do not have to maintain in-house pharmacies.
The drugmakers argue that the rising use of contract
pharmacies has resulted in improper discount claims,
contributing to spending on the 340B program jumping from $6.6
billion in 2010 to $124 billion by 2024.
In 2020, many drugmakers began imposing restrictions on 340B
drug sales using contract pharmacies.
After courts ruled that the Health Resources and Services
Administration, a division of the U.S. Department of Health and
Human Services, lacked the authority to bar such policies,
states including Maine began adopting their own laws.
Lawyers for Novartis and AbbVie ( ABBV ) argued that Maine's law was
preempted by the federal law governing the 340B program, which
does not include any requirement that hospitals be allowed to
use contract pharmacies.
But Nivison noted the statute's silence on how 340B drugs
are delivered and pointed to rulings by two federal appeals
courts in similar cases "as reflecting that Congress did not
intend to preclude state involvement."
Those rulings came in decisions by the 5th and 8th U.S.
Circuit Courts of Appeals, which rejected industry challenges to
similar laws adopted by the states of Arkansas and Mississippi.
Nivison said the state and federal laws worked in "harmony,"
as the state law was designed to prevent limits on the methods
of distribution of drugs while the 340B program was designed to
ensure eligible health care providers could obtain medications
at discounted prices for under-served patients.
"The Court discerns nothing in 340B to suggest that Congress
intended to limit the number of patients for whom covered
entities may prescribe drugs at the discounted rate," Nivison
wrote.
The case is AbbVie Inc ( ABBV ) v Frey, U.S. District Court for the
District of Maine, No. 1:25-cv-00416.
For Novartis: Susan Cook of Hogan Lovells
For AbbVie ( ABBV ): Matthew Owen of Kirkland & Ellis
For Maine: Sean Magenis of the Maine Office of the Attorney
General
Read more:
Judge blocks West Virginia's 340B contract pharmacy law
US Supreme Court will not hear drug industry challenge to
Arkansas contract pharmacy law
Judge won't block Maryland law mandating discounts for
hospitals' outside pharmacies
Judge won't block Mississippi law on discounts for
hospitals' contract pharmacies
Lawsuits pile up over state laws on discounts for hospitals'
contract pharmacies
(Reporting by Nate Raymond in Boston)