Patient Beware Of FDA Fast-Track Policy

Posted on October 27, 2008 in Our Blog,Patient Care,Public Safety

Does the Food and Drug Administration’s fast-track policy for new medical devices help or hurt? According to an article in the New York Times from October 27, 2008, the FDA approval process for medical devices is simple at best. The FDA does not check for evidence of effectiveness but only that the device performs as stated and is not dangerous. After a medical device is approved, medical facilities are free to use the devices and are not obligated to reveal information about the newness of the technology to patients.

The example provided in the article is a breast cancer radiation device known as MammoSite. The FDA approved it in 2002, but the new radiation treatment administered by the MammoSite is still experimental and unproven. One patient was referred to a radiation center that uses MammoSite but was unaware of its experimental status until she opted for a second opinion.

The FDA argues that patients should have access to medical innovations and stands by its approval policy. Critics say patients are the ones who suffer, since the devices are not checked for effectiveness. Patients, critics argue, believe devices are effective when they learn of FDA approval.

What it all comes down to is information. Be sure you are privy to all information, and do your own research!