The US Food and Drug Administration (FDA) plays a vital public health role. It oversees
human and animal medical products, food, dietary supplements, cosmetics, products that …

One of the most vexing problems in drug and device regulation is" off-label" promotion-when
a company markets uses for a product that have not been approved by the US Food and …

The Department of Justice (DOJ) and the US Attorneys' Offices enforce the criminal laws
which, among other things, prohibit pharmaceutical or medical device manufacturers from …

In recent years the federal government has collected billions of dollars from pharmaceutical
and medical device companies in criminal and civil penalties for" offlabel" promotion of their …

Imagine the board rooms of two pharmaceutical companies. Let's call them Company A and
Company B. Company A and Company B are identical in every respect, but they operate …

The False Claims Act (FCA)'has emerged as a key tool in the government's battle against
healthcare fraud. It has been routinely used against false or fraudulent claims made by …

For several years, the Food and Drug Administration (FDA) has been evaluating how best to
regulate manufacturer-sponsored efforts to deliver scientific information about new drug and …

The Food and Drug Administration (FDA) only allows drugs in the marketplace after
pharmaceutical companies prove that they are both" safe" and" effective." 1 Once the FDA …

When a physician prescribes a drug or uses a medical device, most patients would assume
that the drug or device has been approved by the Food and Drug Administration (FDA), the …

Recent changes in law and policies relating to" off-label" product communications by
manufacturers (OLPC) bring to mind the biblical parable of the Prodigal Son. 1 In the …