Sen. Hillary Clinton Pushes for Faster FDA Approvals?

Contact:     Jody Clarke, 202.331.2252

Washington, D.C., November 18, 2005—On her trip to Israel this week, Senator Hillary Clinton (D-NY) took part in a photo-op where she was shown using a device that assists in CPR.  A photo of the demonstration made the Tuesday Washington Times front page.  The Senator probably didn’t know it, but the device she was handling, the CardioPump, is illegal in the United States because the Food and Drug Administration refuses to approve it.  In 1995, the CardioPump became a symbol of the campaign to reform FDA when Newt Gingrich used it to illustrate the agency’s heavy-handed approval process.

The CardioPump is a relatively simple device, consisting of a suction cup that enables paramedics to administer CPR more effectively.  Studies supporting the device have appeared in major peer-reviewed medical journals, and the device is used in a growing number of foreign countries.  FDA has not approved the device due to disputes over the supporting data, but even critics of the CardioPump admit that it poses no new risk to cardiac arrest victims undergoing CPR.

“The fact that the CardioPump is still unapproved in this country indicates that FDA reform has a long way to go,” says Sam Kazman, general counsel at the Competitive Enterprise Institute. “Here we have a device supported by peer-reviewed data, utilized widely abroad, and posing no risks. Why shouldn’t hospitals and doctors be able to make their own decision on whether or not to use it? This is FDA engaging in deadly overcaution.”

Besides Israel, the CardioPump is used in Austria, Australia, Canada, Chile, England, France, Germany, Japan, and Sweden, among others.

For more information on the CardioPump, please see:

Feel a Heart Attack Coming? Go to France; CEI Statement on the CardioPump before the FDA