Putting the Florida Legal Ruling in Perspective The media is full of stories this morning about the ruling yesterday of Judge Vinson, not only that the Individual Responsibility Requirement (IRR) of the ACA is unconstitutional, but also that the entire la

Word came last week from the Obama administration that the Community Transformation Grant program will begin “very soon,” despite the discussion of federal budget freezes. Speaking at the Families USA Health Action conference, an official said the adminis

In the first lawsuit over Johnson & Johnson's "phantom recalls," Oregon’s Attorney General John Kroger argues that Oregon consumers were left in the dark when the company hired parties to covertly buy up potentially defective Motrin from Oregon stores

This week’s news that the NIH is going to take up drug discovery where industry well, sort of left off, is big.  The proposed drug development hub, the National Center for Advancing Translational Studies, would move beyond the NIH’s current basic science

A Pyrrhic Victory The outcome of last week’s vote on repeal was a foregone conclusion from the outset, but the victory was a hollow one. Almost no Democrats broke from their party to vote for repeal. While a few more signed on to the “replace” resolution,

Wishful Thinking Part One: The Vanishing Voter Mandate for Repeal After a pause to remember those who were killed or wounded in Tucson, Congress is set to resume work this week, and the first order of business is a House vote to repeal the Affordable Care

This week Ed Silverman over at Pharmalot asked whether the FDA needed to get tough on some foreign active pharmaceutical ingredients (API) suppliers, citing some pretty hairy findings from inspections of Canadian and Indian factories that triggered the

Here is a blog from our partners at PostScript chronicling  the ground-breaking work by FDA under Dr. Joshua Sharfstein, the departing Deputy Commissioner who lead the agency's work on regulation of prescription drugs and devices.  Since early 2009, Sharf

As you’ve heard by now, FDA Deputy Commissioner Dr. Joshua Sharfstein is leaving his post at the FDA to become secretary of health and mental hygiene for Maryland. The blogosphere's abuzz over what Sharfstein’s move means for the FDA and industry at the t