The U.S. Food and Drug Administration (FDA) is considered by many to be the premier safety and health regulator in the world. The agency oversees about one-quarter of all products Americans consume including food, drugs and medical devices. Most Americans assume they are safe with the FDA at the helm.
But how can the agency serve two masters and claim it is working on behalf of the public?
Besides the public, the other master is the very industry it is supposed to be regulating. In a year-end blog, FDA Commissioner Dr. Margaret Hamburg is not shy about announcing the dual-focus of the agency.
In her essay “Driving Innovation Is a Key Part of Our Mission” she makes the assumption that the public is clamoring for more “innovation.” Consumers Union asked Americans just that question in a poll the consumer group conducted in March 2012. Americans responding overwhelmingly supported strong medical device safety oversight, despite pressure by the device industry to push for “innovation.”
Recent disasters with surgical mesh and metal hip implants show what happens with “innovation,” another word for fast-tracking approvals, puts the FDA into a regulatory lapdog position over the watchdog it is supposed to be.
There are countless examples of the FDA’s association with industry.
The Medical Device Amendments of 1976 were intended to avoid the overregulation of medical devices. Federal regulations spell it out – the FDA must ask for the “least burdensome” valid scientific evidence to prove a medical device is safe and effective. But least burdensome on whom? Certainly not to the poor patients we represent who have metal ions corroding viable tissue and poisoning their blood from metal hip implants.
The Medical Device Innovation Consortium (MDIC) is a private-public collaboration that was announced a year ago with the end goal of speeding up the approval of new devices. The group was formed to counter a slow, thoughtful approach to medical device approvals because that approach was hurting industry. Besides the FDA, members include the Mayo Clinic, the University of Minnesota, Boston Scientific, Becton Dickinson and Medtronic among others. There is no mention of patient safety.
Deputy FDA Commissioner Joshua Sharfstein had ordered a high-level probe into corruption at the Center for Devices and Radiological Health, the medical device arm of the FDA. That was in July 2009. Sharfstein left the agency the next year after Big Pharma and its friends in Congress made it clear in a memo “Anybody but Sharfstein.”
Margaret Hamburg says in her blog that when the FDA is vigilant on behalf of consumers and patient safety and it’s done right, it “can be a key driver of innovation throughout society.” Thoroughness, when done right, takes time, money, focus and personnel. It speeds up nothing.
It’s hard to believe Dr. Hamburg is so proud of the agency’s role as a driver of innovation. Is that really the message that Americans want to hear?