Archive

Another Bad Report Card for the Beleaguered FDA

By Gordon Schnell The Food and Drug Administration (FDA) admittedly has a lot on its plate.  Tasked with regulating the country’s food and medicine supply, not to mention the ever-evolving array of medical devices and procedures, the FDA is the federal agency perhaps most responsible for ensuring our health and well-being.  If the agency does not perform up to task, a lot of people are affected.  So it is no...

CVS Sub Caught Duping Consumers in Prescription Drug Purchases

By Marlene Koury In one of the first False Claims Act settlements involving Medicare's "Part D" prescription drug program, CVS Caremark subsidiary, RxAmerica, agreed to pony up $5.25 million to resolve charges that it submitted false pricing information to the Centers for Medicare & Medicaid Services (CMS).  This is the government body that oversees the Medicare and Medicaid programs.  It also makes available the...

The Fraud Behind the Fraud of Off-Label Drug Marketing

By Gordon Schnell It has been one of the most common means for drug companies to get around what can be the very rigorous and time-consuming process of securing FDA approval for selling drugs.  That is, taking drugs that the FDA has approved as safe and effective for one particular use and marketing them to the medical community and the public for an entirely different set of uses.  This so-called off-label...

FDAGate -- The Latest Lapse in Government Enforcement

By Gordon Schnell In what quickly has become the most recent "gate" scandal in Washington, the evidence continues to mount that the FDA acted to stifle whistleblowers within its own ranks.  It all began several years ago when a half-dozen FDA scientists and doctors objected to certain imaging devices for mammograms and colonoscopies because of the high levels of radiation they believed the equipment emitted.  The...