With the off-label/intended use controversy still simmering, a bill has debuted in the U.S. House of Representatives that would restrict the federal government's ability to pursue charges against manufacturers of drugs and devices based merely on "actual or constructive knowledge" on the part of the manufacturer that the drug, device or biologic will be used outside the FDA-approved labeling. Should the bill pass into law, it would close the book on one of the most hotly contested areas of commercial speech law in recent memory, but there are skeptics about the need for such legislation. Read More
