OIG will investigate off-label claims

Share this article:
The HHS Office of the Inspector General (OIG) says in its FY 2008 work plan that it will "assess FDA's oversight and review of allowable off-label drug promotion and enforcement." Lately, the federal government has won numerous pharmaceutical company settlements under the False Claims Act that are centered on off-label drug uses.

The work plan also says CDER's generic drug approval process will come under the microscope in 2008, particularly the reasons for the growing backlog of submissions.

“We will review FDA's timeframes for reviewing original generic drug applications and identify factors that affect the timely review of these applications,” it says.

Despite regulations mandating review actions within 180 days after submission, over 1,000 generic drug applications are currently pending, with one-third of these exceeding the statutory time limit.

Share this article:
close

Next Article in Features

Email Newsletters

More in Features

Antidote: On Cystic Fibrosis treatments

Antidote: On Cystic Fibrosis treatments

Recent treatments in CF, including the inhaled antibiotic Tobramycin, have increased lifespan well into adulthood.

The $3 generic and the $1,000 pill: pharma outsiders just don't get it

The $3 generic and the $1,000 pill: pharma ...

What do you call the people who treat medical breakthroughs as if they were bank heists? Malicious? Uninformed? Not with it?

Leadership Exchange Uncut : The Agency-Client Relationship

Leadership Exchange Uncut : The Agency-Client Relationship

Click the above link to access MM&M's first Leadership Exchange Uncut e-book, "The Agency-Client Relationship"