Tuesday, February 26, 2008

Lucentis Congressional Oversight Hearing Put On Hold

Genentech will get a reprieve from lawmakers investigating the company’s pricing practices for its age-related macular degeneration drug ranibizumab (Lucentis).

The Senate Special Committee on Aging, which has been conducting the investigation, has decided not to initiate an oversight hearing on the issue.

“I don’t think that we’re going to schedule a hearing at this time,” says a Senate investigator. “However, we may have some staff findings on this matter which we may make public in the near future.”

While the committee aims to win the battle of public opinion, it’s a welcome development for Genentech knowing that one of their executives won’t be called in front of a Congressional panel—along with the television cameras—for intense questioning.

Last October, Senate Special Committee on Aging Chairman Herb Kohl (D-Wisc.) sent a letter to the Centers for Medicare and Medicaid Services asking why Medicare was paying a steep premium for Lucentis when the “chemically similar” cancer drug bevacizumab (Avastin) can be used off-label for AMD at a fraction of the cost.

The committee then launched a formal investigation in November with letters to FDA and Genentech. To read the specifics, click here.

CMS responded to the October 2007 committee letter at the end of February, according to the Senate investigator. Staffers intend to put together a staff memo containing findings from the investigation.

The staff identified “interesting details” in the FDA inspectional papers, e-mails and interviews, as well as noteworthy findings on the issue of whether Genentech promised to provide free Lucentis for the NIH/National Eye Institute-sponsored, head-to-head CATT study evaluating microdoses of Avastin compared to Lucentis (more on this later).

The findings of the investigation could be made public in a few weeks.

1 comment:

Anonymous said...

I personally think that it is pretty convenient, a drug almost identical in makeup costing 20 times more. This is what I call "having your cake and eating it too".