In response to the ruling, Senator Barbara Boxer (D-CA) introduced a bill last week that would bring greater accountability and transparency to the Food and Drug Administration’s (FDA) regulation of all medical devices. Millions of Americans are implanted with devices ranging from pacemakers to breast implants, yet don’t realize that medical devices are not rigorously approved like pharmaceuticals. The bill (S.3020), the Food and Drug Administration Accountability and Transparency Act, will provide the FDA with several tools to help ensure the safety of these devices. Because of less stringent safety approval mechanisms, the FDA allows manufacturers to conduct post-approval studies. But in many cases these studies are altered or not completed and consumers are left in the dark about safety problems. “The FDA has been charged with a central role in safeguarding the health of our nation. Since the creation of this agency more than 100 years ago, the role of the FDA has expanded to ensuring the safety of foods, drugs, medical devices, and even cosmetics. Too often, however, the FDA lacks the authority or the resources to safeguard the health of our nation….[this act] would give the FDA several tools to ensure the safety of medical devices, including larger fines to hold these companies accountable,” Senator Boxer said. Medical device manufacturing is a $75 billion industry, with considerable lobbying power, which enables them to secretly waive or alter post-approval agreements with the FDA, without informing consumers. This bill would end this practice by requiring such changes to be placed in the Federal Register.
Senator Boxer also stated: “If the Secretary of Health and Human Services determines that a manufacturer’s failure to conduct post-market surveillance is a risk to public health, this legislation give the Secretary the authority to notify health professionals that have been using these devices about any safety concerns.”
Sybil Niden-Goldrich, a long-time advocate of the breast-implant issue, applauded Senator Boxer: “More than 360,000 women received breast implants last year—a 40% increase over the last five years. Yet none of these women knew silicone implants were approved on the basis of post-approval studies that subsequently were watered down by FDA and aren’t being conducted. Senator Boxer’s bill would correct these grave injustices.”