In its first year of auditing 340B facilities for compliance with drug discount rules, the HHS agency is investigating 45 randomly selected entities and six “targeted” entities that are the subject of specific allegations of non-compliance. About 250 hospitals have been decertified from 340B and may have to pay back discounts to drug makers.
The HHS Office of Pharmacy Affairs has launched on-site audits of 51 health care facilities that receive the federal 340B program’s deep discounts on outpatient drugs to ensure that they are in compliance with program regulations.
“OPA this year has selected 51 sites for audit,” OPA Director Krista Pedley said at the Annual 340B Coalition Conference in Washington, D.C., on July 9
Decision in AstraZeneca’s lawsuit against the Health and Human Services Department is a precedent-setting victory for the government and a blow to manufacturer efforts to block the price negotiation program.
Advisory committee for Capricor’s deriamocel planned, regenerative medicine advanced therapy designations proliferate for osteoarthritis, and the ranks of dual RMAT/breakthrough therapy designation holders grow.
Pink Sheet editors discuss the appointment of Vinay Prasad as the new director of the Center for Biologics Evaluation and Research and revelations that FDA layoffs now are hindering development of guidance documents.
Agency staff once again have access to the Lexis-Nexis legal and news database, but are still waiting for access to journals, and laid off librarians have not been reinstated.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
President Trump's ongoing interest in the policy, which would ensure the US government pays no more for prescription drugs than the lowest price available in comparable countries, continues to gain attention.
HHS Secretary Robert F. Kennedy Jr. regularly decries the “conflicts of interest” he believes abound in advisory committees, but his concerns, as well as a recent “policy directive” eliminating industry representatives, seem driven by a misunderstanding of the panels’ jobs.
