There is growing evidence that the Center for Drug Evaluation and Research, the part of the agency that regulates prescription drugs, has become the servant of the industry it regulates. This has resulted in the sale of drugs of uncertain benefits, some with serious side effects, and in the agency’s failure to respond promptly to evidence that a drug is dangerous.

The FDA’s current approach to drug oversight in the postmarketing setting is not sufficiently systematic and does not ensure that it assesses the benefits and risks of drugs consistently over a drug’s life cycle.

How did we get to a point where we can't trust the equipment doctors use for—and in—our bodies?

GAO recommended that all class III devices—implantable, life sustaining, posing significant risk to the patient—go through the more stringent Premarket Approval (PMA) process and not the Premarket Notification 510(k) process.

Food and Drug Administration (FDA) officials bowed to political lobbying and circumvented normal process to approve Menaflex, a knee implant made of cow collagen, over staff scientists' objections. Other FDA scientists have called public attention to systemic political interference in the approval of medical devices.

The FDA’s slow and secretive response to drug approvals based on fraudulent studies by Cetero Research was not an anomaly.

Merck yanked Vioxx on Sept. 30 because a new study had found a higher rate of heart attacks and strokes in patients taking the drug than in those on a placebo. But the new Vioxx study was not the first to raise concerns about heart attack and stroke risk.

A new study found that for new oncology drugs between 2003 and 2010, the median time for FDA approval was six months, compared to nearly as long for the EMA.

A review of the data suggests instead that it takes the same amount of time or less for patients to gain access to innovative, high-risk medical devices in the U.S. as it does in the four largest European markets (Germany, France, Italy, and Britain) — largely because patient access is generally delayed until reimbursement decisions are made, which often takes substantially longer in Europe than in the United States.

One year on from a breast implant scandal that shook confidence in Europe’s light-touch system for regulating medical devices, lawmakers and manufacturers are at loggerheads on ways to protect patients from shoddy products.