Sunday, May 29, 2011

Society of Hospital Medicine eyed in Senate Finance Committee Report

---along with others concerning their petition to the FDA to delay the approval of generic Lovenox. I first blogged and offered my opinions about the controversy here. Health Care Renewal has posted an update here. The full committee report is here.

As I said before, conflict of interest aside, I wish SHM would articulate the scientific rationale for their petition to the FDA. From reading the report I gather the thinking is that for complex molecules such as LMWHs, the copying and producing of bioidentical products is unreliable, such that clinical trials for generics are warranted, just as if they were entirely new drugs. I have no idea whether that claim is true.

No comments: