May 1 (Reuters) - Healthcare and drug industry groups on
Wednesday urged a U.S. appeals court to revive their challenge
to a law requiring manufacturers to negotiate the prices of some
drugs with the U.S government's Medicare health insurance
program or pay heavy penalties.
Pharmaceutical Research and Manufacturers of America
(PhRMA), the Global Colon Cancer Association and the National
Infusion Center Association (NICA) sued the government last
year, claiming the program, a signature initiative of Democratic
President Joe Biden, violated the U.S. Constitution by giving
too much power to federal regulators and imposing excessive
fines on companies that refuse to participate.
But the arguments before a three-judge panel of the 5th U.S.
Circuit Court of Appeals in New Orleans hinged on a narrower
issue: whether a Texas judge was right to throw out the case
after concluding that he lacked jurisdiction over it.
U.S. District Judge David Ezra in Austin, Texas, ruled in
February that NICA can only pursue its claims through an
administrative process for challenging Medicare reimbursement
decisions. The organization has said that its infusion center
members' Medicare reimbursements are tied to the prices of drugs
they administer, meaning that a ceiling on prices could lead to
lower reimbursements.
Because NICA is the only plaintiff based in Texas, the judge
said, the other plaintiffs cannot go forward with their lawsuit
there without it.
John Elwood of Arnold & Porter Kaye Scholer, arguing for the
plaintiffs, told the 5th Circuit panel that the administrative
process, which begins within the U.S. Department of Health and
Human Services, cannot address NICA's constitutional claims. He
also said it was the negotiation program itself, rather than any
loss of money, that the group was challenging.
"We are injured by the decision-making process that is
constitutionally invalid," he said.
Catherine Padhi, a lawyer for the government, said there was
no right for healthcare providers to be involved in the
government's decisions about Medicare.
Circuit Judge Jennifer Elrod, who was appointed by
Republican former President George W. Bush, appeared sympathetic
to the plaintiffs' arguments. She said the government was using
"monopsony power" by forcing companies to negotiate, pay heavy
fines or leave Medicare altogether, and that "the (Federal Trade
Commission's) heads would explode" if a private company acted
similarly.
"This is challenging a novel, unprecedented price-setting
program in a setting where the government is the 800-pound
gorilla," she told Padhi, later asking, "How would this at all
be lawful in any way?"
Padhi stressed that the appeal concerned only the claims of
NICA members, who do not sell drugs directly to the government,
and not drugmakers' claim that the program is unlawfully
coercive and punitive. But she also rejected the idea that
drugmakers' rights were violated.
"There's certainly no right to sell a product to the
government at any price you wish," she said.
The other two members of the panel - Circuit Judges Kyle
Duncan, who was appointed by Republican former President Donald
Trump, and Irma Ramirez, who was nominated by Biden, a Democrat
- did not ask any questions.
The argument came two days after a New Jersey judge rejected
challenges by Johnson & Johnson and Bristol Myers Squibb to the
drug pricing program, which is part of the 2022 Inflation
Reduction Act. So far all four federal judges to rule on
lawsuits over the program have rejected them.
If the price negotiations are allowed to go forward, the
negotiated prices for the first set of drugs chosen for the
program would be set in September, with more drugs added in
future years.
The chosen drugs include Merck's ( MRK ) diabetes drug Januvia,
Bristol Myers Squibb ( BMY ) and Pfizer's ( PFE ) blood thinner Eliquis and
AbbVie's ( ABBV ) leukemia treatment Imbruvica.
The program aims to save $25 billion in drug costs annually
by 2031. Industry analysts have said that the negotiated
discounts could be steep, ranging from the statutory minimum of
25% to as much as 60%.
The case is National Infusion Center Association v. Becerra,
5th U.S. Circuit Court of Appeals, No. 24-50180.
For plaintiffs: John Elwood of Arnold & Porter Kaye Scholer
For the government: Catherine Padhi of the U.S. Department
of Justice
Read more:
J&J, Bristol Myers lose challenges to US drug price
negotiation program
Pharmaceutical group's lawsuit over Medicare drug price
program dismissed
Pharmaceutical trade group sues US over Medicare drug price
negotiation plans
(Reporting By Brendan Pierson in New York)