Game over? Never. A nursing home FCA case gets a fifth look and OTCs shoot for a new target audience

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I’m Kevin Yankowsky, and this is Norton
Rose Fulbright’s The Pharma 5.

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Number five on our list this month,

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Fifth time is the charm. A
A nursing home kickback case.

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A whistleblower is getting
a fifth bite at the apple.

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The nursing home will now allege that

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the pharmacy service provider PharMerica 
offered below market drug prices to nursing

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homes’ Medicare Part A patients, in exchange
for the opportunity to provide

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the same drugs, at market rate,
to their Part D patients.

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A New Jersey Federal Court has decided
to allow the amendment on

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the theory that submitting “prescription drug
event” data electronically to CMS in

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and of itself amounts to a “claim” under
the False Claims Act, simply

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because CMS relies on the data.

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Number four on the list is something
new to worry about.

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The FDA has now jumped into a new enforcement
area—manufacturer obligations to

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report clinical trial status to
the ClinicalTrials.gov website.

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The agency just issued its
first ever trial report,

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Notice of Noncompliance to Acceleron
Pharma for its failure to report on an

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efficacy trial for a new kidney cancer drug.

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Number three on our list is a little
bit of bad news on preemption;

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this time out of the Northern
District of Georgia.

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Georgia Attorney General’s office brought
an action against a stem cell clinic,

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asserting that the clinic falsely
represented the safety and

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the efficacy of its non-FDA
approved products.

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The clinic remove the matter to Federal
Court on the grounds of FDCA preemption.

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However, a Georgia Federal Court remanded,

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citing <i>Wyeth’s</i> admonition that
“Congress created room

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for state law remedies to further consumer
protection under the FDCA.”

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Our number two item takes us into the
ever-exciting world of Indian law.

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And yes, that is still the proper term

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for jurisprudence dealing with
Native American tribes.

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The D.C. Circuit Court of Appeals drew
boundary lines in a dispute over

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whether the Indian Self-Determination and
Education Assistance Act requires

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the federal Indian Health Service
to pay the administrative

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and overhead costs of healthcare
programs operated by

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a Native American tribe.

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The court held it does not so require.

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The D.C. Circuit affirmed the dismissal
of the Swinomish Indian Tribe’s action,

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noting that the tribe had actually
paid the claimed administrative

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and overhead costs with funds it received
from alternative sources.

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In this particular case, federal
Medicaid and Medicare funds.

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The court reasoned that the Act does not
require IHS to reimburse these additional

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costs “when a tribe spends money it actually
received from other sources...

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like insurance providers.”

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Our number one item is a bit of fun news.

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In a first, as far as we know,

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a medicine manufacturer has made
a move to reach out directly to

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the video gaming community, a population
that has certainly grown recently

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and definitely during the pandemic,

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with surveys reflecting that even old fogies

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and medical manufacturers are getting in
on the Fortnight and Call of Duty fun.

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GSK’s Excedrin brand is now touting not
only its pills as pain relief,

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but it also creates a full mindfulness
routine for gamers with tips like eye breaks,

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deep breathing exercises and ways to
maintain a positive attitude in

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the face of Bad Omens. Excedrin is spreading
the word with well-known professional gamers

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on social media sites like the more than
aptly named Twitch. Expect to see more such

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community outreach from other medical
providers in the future.

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Well, that's all the news they've told me
is fit to read. Thanks for watching.

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We’ll see you next time on the next edition
of Norton Rose Fulbright’s The Pharma 5.