Testimony by Brandel France de Bravo
December 5, 2012
I am Brandel France de Bravo, and I am pleased to have the opportunity to speak on behalf of the National Research Center for Women & Families. Our Center does not accept funding from device companies, and I have no conflict of interest.
Our nonprofit Center analyzes and reviews research on medical issues, and provides objective and understandable information to patients and providers. We are an active member of the Alliance for a Stronger FDA, a nonprofit coalition of corporations and nonprofit organizations that has successfully increased resources for the FDA by billions of dollars.
I have a Master’s in Public Health from Columbia University and have been working on health and safety issues for over 20 years.
After reviewing the safety and efficacy data on External Counter-Pulsating (ECP) Devices, we have concerns about the FDA’s recommendation to split the classification, down-classifying one limited indication to Class II with special controls, and requiring all other uses to be cleared through the Class III PMA process.
We agree that the research supporting the use of ECP devices for refractory chronic stable angina is convincing. It’s nice to know that something that’s been on the market and been used by at least 18,000 people with coronary artery disease a year for thirteen years or more actually helped some of them. There is no evidence of substantial harm.
We were disheartened, however, to see how little research had been done, or even collected and presented to the FDA, by manufacturers on the efficacy of ECP devices for the many other cleared uses, which range from cardiogenic shock to necrotizing cellulitis. The wide array of unsubstantiated cleared uses underlines the potential for the misuse of a medical device once it is on the market.
The FDA synthesis reported only one recall—Class II, moderate risk—but we found a second Class II recall by checking the Product Life Cycle. The recall described in FDA’s synthesis involved customer complaints and software errors. Assuming that no patients were physically harmed by recalled ECPS, continuing use of devices with no demonstrated efficacy contribute to the high cost of health care, which harms everyone.
While the safety profile of the device thus far—and I emphasize thus far—appears acceptable, we have reservations about the FDA’s proposal to split the classification regulation. A split can easily become a loophole: devices can legally be used off-label. Unfortunately, this week’s court decision (United States v. Caronia), says that companies have the right to promote their products for off label uses. That would certainly be harmful to patients, and would be reason enough to keep this product as a Class III device for all uses.
Secondly, even though the ECPs have been useful for refractory chronic stable angina, there is no guarantee that future modifications to ECPs for that purpose will be as safe or effective as the ones currently on the market. Without the safeguards of the PMA process, there is no way to know if new ECPs would be as good as the ones currently available. Clinical trials are needed—not just lab tests—to make sure that the new products are safe and effective. As the Institute of Medicine has stated, the 510(k) process does not require evidence of safety or efficacy.
In conclusion, we do not support the FDA’s recommendation to down-classify ECPs for refractory chronic stable angina. We would support allowing the ECPs that are currently on the market to be allowed to stay on the market with labeling to include the phrase “all 510(k) cleared ECPs are prohibited from being used for any indication other than refractory chronic stable angina.” We urge you to require all new versions of ECPs to be classified as Class III and go through the more rigorous PMA process for any uses.