American Enterprise Institute (AEI) scholar Scott Gottlieb, MD a former senior adviser to the Center for Medicare and Medicaid Services (CMS) warns that a new ruling by CMS will force people to get open-heart surgeries that might have been avoidable.

Today, URL Pharma was acquired by Takeda for nearly $800M.  The story here in brief is that for hundreds of years, colchicine was used for the treatment of gout and other conditions; it was an effective drug but had to be used carefully. URL invested in the formulation development and clinical studies required for colchicine, and ultimately received FDA approval in 2009. 

This is an all too familiar story, the FDA impeding useful innovations in the US entrepreneurs here are forced to test promising medical devices in costly animal studies for years before they can advance their products into clinical trials. In response, American device makers are moving their business overseas.

Here is another good news/bad news column about the 112th Congress.

Requirements to test new drugs against older medicines would add a major hurdle to the development and approval of new medicines. Equally important, the proposed mandates are unnecessary.