Update: HHS Reverses Course, Declines to Exclude Drug Co. CEO

We noted a few weeks ago impending action by the Inspector General of the Department of Health and Human Services to exclude Forest Labs CEO Howard Solomon from government contracts for his company’s plea of guilty to federal law violations.  Mr. Solomon hadn’t been charged with any crime nor did he personally plead guilty to any crime.

This past Friday, it was reported that HHS had decided not to pursue such a course of action against Mr. Solomon. A Business Week story related some interesting and certainly troubling news about what else the government was considering with regards to the Forest Labs guilty plea:

A judge yesterday unsealed court filings showing regulators considered starting an exclusion effort against eight of the drugmaker’s executives over illegal sales of one of the company’s medicines.”

The Delaware judge had ordered the documents to be released pursuant to a legal action by the Icahn Group, which is waging a proxy battle with the Forest Labs board.

Governor Rick Perry Puts “Off-label” Medical Therapy on Stage

A beneficiary of off-label medicine

Cross-posted by Forbes.com at WLF’s contributor page

Texas Governor Rick Perry is the latest beneficiary of so-called off-label medical therapy. Earlier this week, USA Today reported that Perry’s back surgery last month involved a stem cell therapy that is currently approved by the Food and Drug Administration (FDA) solely for bone marrow transplants.  The procedure went smoothly, however, and Perry’s health is now much improved thanks to his doctor’s knowledge of the therapy’s off-label application.

Unfortunately, off-label success stories like Perry’s are less common than they should be.  The reason is simple:  drug companies are prohibited from pro-actively sharing information about their products for uses beyond what the FDA has approved.  If a drug company discovers that its drug can be used to treat disease X, but it has only been FDA approved for disease Y, the company has to essentially remain mum about its solution to X.  Without this useful information, doctors are less likely to know about the drug’s beneficial alternative applications.  This ban on off-label communication is an offense to both American patients and American notions of free speech. Continue reading “Governor Rick Perry Puts “Off-label” Medical Therapy on Stage”