News & Analysis as of

Advisory Opinions Prescription Drugs Food and Drug Administration (FDA)

Baker Donelson

OIG Permits Pharmaceutical Manufacturer to Offer Free Drug to Patients in Advisory Opinion 21-01

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In its March 18, 2021 Advisory Opinion (AO), AO 21-01, HHS Office of Inspector General (OIG) determined that a pharmaceutical manufacturer that produces a drug as a one-time, potentially curative treatment (the Drug) may...more

Holland & Knight LLP

Healthcare Law Update: April 2021

Holland & Knight LLP on

William F. Gould In United States v. Merino, No. 19-50291, 2021 WL 754589 (9th Cir. Feb. 26, 2021), the court of appeals reversed the conviction of Marina Merino of conspiracy to commit healthcare fraud in violation of 18...more

Bass, Berry & Sims PLC

OIG Issues Favorable Advisory Opinion (No. 21-01) on Free Drug Program

On March 18, the Office of Inspector General (OIG) issued a favorable Advisory Opinion No. 21-01 (Opinion) regarding a free drug program sponsored by a pharmaceutical manufacturer of a personalized cell and gene therapy...more

King & Spalding

OIG Issues Favorable Advisory Opinion Regarding Free Drug Provided by Pharmaceutical Manufacturer to Patients

King & Spalding on

On March 18, 2021, OIG issued Advisory Opinion 21-01, addressing whether a pharmaceutical manufacturer may provide a personalized medicine made from a patient’s own cells as a one-time, potentially curative treatment (the...more

King & Spalding

OIG Issues Four Advisory Opinions

King & Spalding on

From December 23, 2020 through December 31, 2020, the OIG issued several advisory opinions. The advisory opinions analyzed (1) a program for a pharmaceutical manufacturer to provide financial assistance to certain patients,...more

Baker Donelson

OIG Okays Assistance Arrangement Offered to Drug Patients in Advisory Opinion 20-02

Baker Donelson on

In Advisory Opinion 20-02, the Office of Inspector General (OIG) approved certain lodging and travel assistance offered by a pharmaceutical manufacturer to patients being administered a drug manufactured by the pharmaceutical...more

Mintz - Health Care Viewpoints

OIG Advisory Opinion Permits a Pharmaceutical Manufacturer to Provide Financial Assistance to Needy Patients Receiving Risky Cell...

The Office of Inspector General for the U.S. Department of Health and Human Services (OIG) recently issued a favorable Advisory Opinion regarding a proposal by a pharmaceutical manufacturer (Requestor) to provide financial...more

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