NRC for Women & Families responds to FDA’s proposed changes to the review of medical devices

Diana Zuckerman, President of the National Research Center for Women & Families

January 19, 2011

When the FDA announced their intention of improving the safety standards for thousands of new medical devices, well-paid lobbyists fought back.  Unfortunately, whether they are foreclosure companies, coal mines, or medical device makers, there are companies that would rather spend millions on lobbyists to fight safety measures than spend that same money to improve safety and save lives.  Industry lobbyists won, and the public lost.  As a result, FDA has backed down on important safety measures that would have saved lives.  I have spoken with men and women across the country whose children and loved ones were killed by unsafe medical devices.  They feel betrayed because these products were not proven safe or effective in clinical trials, and FDA allowed them to be sold anyway.

If the FDA implements its proposals to improve the standards for medical devices, patients will live longer, happier lives.  It is tragic that as a result of lobbyists fighting FDA’s proposed safeguards, lives will be ruined.

Reading the FDA report gives the impression that FDA backed down on several safeguards as a result of unfavorable comments.  FDA decisions should not be based on a popularity contest, especially since lobbyists rig the results.  The FDA’s job is to protect us by ensuring that all medical products are proven safe and effective before they can be sold to you or me or to people we care about.   The FDA can do that by helping companies meet high standards that protect patients and companies from harm.