Critics Say F.D.A. Rushes Approval of Medical Devices



Food and Drug Administration documents that are part of an internal investigation show that many of the front-line scientists working there have had serious concerns that the agency’s managers have become too lenient with the industry they are supposed to regulate.

Nine agency scientists first complained to F.D.A. commissioner Andrew C. von Eschenbach last May, and criticize the medical device approval process. They say too many devices gain F.D.A. approval without extensive testing, as well as state that an agency supervisor forced the scientists to alter reviews of one device in particular. The group has also written letters to Congress, which announced they would begin an investigation last November, and to President-elect Obama’s transition team.

Imaging Device

The device at the center of this is called the iCAD SecondLook Digital Computer-Aided Detection System for Mammography. It is an imaging device that helps radiologists detect breast tumors. It is made by Fujifilm Medical Systems and based in Stamford, Connecticut. While F.D.A. scientists were looking at the device, they were also asking the manufacturer to test it more rigorously. This was holding up the approval process. As a result, Fujifilm Medical Systems representatives called their district’s Congressional offices and spoke with then-Congressman Christopher Shays. Shays then called the F.D.A. demanding action. However, Shays says that he merely asked the F.D.A. to make a decision, and not to request approval.

Agency scientists say the iCAD was never tested by those who would use it under the conditions it was meant to be used. “This,” they say in the letter, “is the most basic and fundamental requirement of all F.D.A. submissions.” They say that device risks include missing cancer, or causing unnecessary biopsy or surgery, as well as unnecessary radiation.

Lax Oversight

Critics outside the agency say situations such as this are the result of minimal oversight, and a product of the Bush administration that has, according to Diana Zuckerman, president of the National Research Center for Women and Families, “finally made the devise approval process so meaningless that it’s intolerable to the scientists who work there.” Zuckerman adds, “Virtually everything gets approved, no matter what.”

Some scientists tend to agree with critics like Zuckerman. According to them, F.D.A. managers consistently insisted that medical devices go through an abbreviated review instead of the extensive clinical trials they should have gone through. Last year, only 41 devices went through the extensive and rigorous process while over 3,000 were given abbreviated reviews.

This includes a device manufactured by an Israeli company called Shina Systems. They had applied for approval for a medical device that combines x-rays with CT images, and is used to help cardiac surgeons during stenting procedures and angioplasty. They also wanted an abbreviated review. An F.D.A. supervisor asked scientists to consider this shortened process after discussing the matter with Shina representatives.

Dr. Brian Lewis, a cardiologist with the F.D.A., believes an extensive review is necessary since, “should the images be misleading F.D.A. could expect immediate misguidance of catheters and possibly puncture of coronary vessels or overaggressive, inappropriate or inadequate stent or balloon use.”