Approval process for devices blasted
The government’s system for regulating many medical devices like artificial hips should be abandoned and replaced because it fails to examine their safety and effectiveness before sale, according to a report released yesterday by one of the nation’s top scientific groups.
The report’s unequivocal finding was unexpected, and it unleashed reactions including outright rejection by industry officials, an embrace by patient groups, and seeming disbelief from federal regulators, who had commissioned the review.
The report by the Institute of Medicine follows several high-profile recalls of medical devices in recent years, like one involving so-called metal-on-metal artificial hips that have failed in thousands of patients, crippling some of them. In its report, the panel found that existing rules used to approve many devices were never intended to play the critical role of screening out dangerous or ineffective products.
The panel urged the Food and Drug Administration to devise a new approval system for so-called moderate risk devices – a category that now includes artificial hips, external heart defibrillators, and hospital pumps – concluding that the current one was not fixable.
“If you want to make sure that a product is safe and effective, you have to start by asking the question whether it is safe and effective,’’ said William Vodra, a member of the 12-person panel assembled by Institute of Medicine and a lawyer who has worked closely with device producers. The Institute of Medicine, a part of the National Academy of Sciences, is a prominent organization that is asked to review many complex public health issues.
It is not immediately clear what impact, if any, the report will have or how its findings can be implemented; the recommendations are only advisory to the FDA. But at a minimum it quickly defined the boundaries of what is likely to be a high-powered Washington lobbying battle in coming months over the outlines of future device regulation.
Even before the report’s release, industry allies had waged an aggressive campaign to discredit it and had taken legal steps intended to bar the FDA from adopting its recommendations.
Yesterday, the Advanced Medical Technology Association, a trade group that represents device industry giants like Medtronic, Boston Scientific, and Johnson & Johnson, dismissed the report, saying it did not deserve serious consideration from Congress or the White House.
- Barry Meier – Study Faults Approval Process for Medical Devices (earlsview.com)
- 510(k) approval process is ‘too big to fail – no matter how flawed it may be (medcitynews.com)
- FDA 510K Process – Another Issue – Risky pelvic mesh highlights worries about FDA process (earlsview.com)
- Will the DePuy Pinnacle Bring the Next Wave of Lawsuits? (earlsview.com)
- Institute of Medicine – Public Health Effectiveness of the FDA 510(k) Clearance Process (earlsview.com)
- Study Faults Approval Process for Medical Devices (nytimes.com)
- 510(k) reforms: FDA downplays the impact of the IOM study on the eve of its release (earlsview.com)
- Report: IOM review of the FDA 510(k) process due Friday (earlsview.com)