US OIG's first-ever rescission means the advisory is revoked retroactively to its date of issue, which could lead to anti-kickback enforcement actions against behavior by the charity and manufacturer donors since then.
The US HHS Office of Inspector General is rescinding an advisory opinion concluding that a copay assistance program for Medicare beneficiaries does not raises anti-kickback concerns because it discovered the group running the program provided pharmaceutical manufacturer donors the ability to steer patients to certain drugs.
"We have determined that the public interest requires us to rescind" the opinion, OIG announced Nov. 28. The advisory opinion...
The US FDA Commissioner pushed for a rebalancing of the US’s pharmaceutical supply chains while also stressing that there is a role for US-China commerce that would be risky to compromise.
A total of 748 key medicines are now affected by the four-month stock requirement, compared with 422 in 2021.
The UK regulator approved 16 medicines containing a new active substance in the first half of this year, while the European Commission issued marketing authorizations for 20 NAS-containing drugs.
Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’
Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.
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