05292017Headline:

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Consumer Reports Criticizes FDA Medical Device Approval Process

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Consumer Reports, the organization behind the magazine famous for its “Best and Worst Cars” annual issue, now is taking issue with the U.S. Food and Drug Administration (FDA) approval process for medical devices, such as hip implants. Is it any surprise that Consumer Reports, a non-profit based in Yonkers, New York, has scrutinized the FDA's “Fast Track” approval process, also known as “Pre-market Notification", or 510(k) – the numbered section of the Food, Drug and Cosmetic Act – approval process that blesses devices to be implanted in millions of Americans?

The magazine, which has 8 million subscribers and hosts the website www.ConsumerReports.org, is critical of the FDA's attempts at protecting consumers, by "doing too little to protect consumers from hastily approved devices” which, once approved by the FDA, get in the medical device market, become implanted in patients and often harm or kill recipients. In the recent past, “Millions of devices, including artificial hips, … heart stents, and pacemakers” have been recalled, adding up to about 700 different products a year.

Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, himself noted that changes in the approval process should take place. The medical device industry, however, would like to leave the process as is or continue to streamline it—making it easier for devices to get on the market. Approximately 4,000 new devices were approved by the Fast Track process in 2009. Whether hip devices—some of which have caused damage to the central nervous system—or surgical mesh implants which have been in the news recently, devices that are similar to previously approved devices move through the process quicker and get on the market without what many authorities feel is adequate testing.

Presently “Congress is reviewing fees that industry pays to the FDA in exchange for speedier review times,” but this is a challenging inquiry because “fees from makers of drugs and medical devices provide more than a third of the FDA’s funding.” One might call it device payola. Approximately 93,000 people throughout the world have Johnson & Johnson/DePuy’s ASR hip system (the one recalled because of the defective metal on metal design) implanted in their bodies— there are thousands of lawsuits already pending because of this defective device. The ever-present argument of benefit vs. risk is the underlying theme of the current concern over the device approval process. In this writer's view, the Fast Track-approval process needs to be reviewed; often, when the manufacturers are left essentially unchecked, and when those manufacturers are faced with stiff competition and short deadlines to get competing devices (or drugs) out into the market, shortcuts are taken – like not thoroughly testing a device, or "ignoring" test data – that result in an unsafe product getting on the market. The ultimate cost to the recipient, in pain, suffering, inconvenience, and economic expense, combined with the cost to the manufacturer, is too great.