January 16, 2009
Report Criticizes F.D.A. on Device Testing
By GARDINER HARRIS
WASHINGTON — Most medical devices have never been shown to be safe or effective, and for the riskiest devices this must change, Congressional investigators concluded in a report released Thursday.
The Food and Drug Administration has promised for decades that it would fix the problem. It has not, leading the Government Accountability Office to state in the report that “it is imperative that F.D.A. take immediate steps” to fix its system for approving devices.
Consumer advocates responded that the agency was failing to protect the public, and industry groups acknowledged that the system was flawed in many areas.
In recent years, the accountability office, Congress’s auditing arm, has chastised the F.D.A. as failing to put into effect its own plan to protect the nation’s food supply, as failing to adequately inspect the foreign drug plants that provide most of the nation’s medicines and as being so hobbled by bureaucratic infighting that it fails to detect emerging drug dangers.
Each time, the agency has largely agreed with the investigators’ findings and promised to do better. The difference this time is that nine scientists within the agency’s device division are echoing critics’ claims of a corrupted review process.
The scientists have written letters to Congress and to President-elect Barack Obama seeking significant changes at the agency. The agency and Congress are conducting investigations into their claims.
In a news conference on Tuesday, the agency’s commissioner, Dr. Andrew C. von Eschenbach, a urologic oncology surgeon, likened the agency to a cancer patient.
“It is a great shock and surprise when someone says you have cancer,” said Dr. von Eschenbach, whose last day on the job will be Friday. “The truth of the matter is that process has been going on for a long time before it became apparent in that particular way.”
As recently as April, Dr. von Eschenbach had declared that the agency was “eminently successful up to this period of time” and that its budget was largely adequate. After repeated drubbings before Congress, he acknowledged that the agency was falling short and that it needed a major and rapid infusion of new money and staff members.
Asked why the Bush administration needed nearly eight years to recognize this crisis, Dr. von Eschenbach said that “sometimes it takes a crisis before” such recognition occurs.
Most medical devices are given quick approvals with minimal testing because manufacturers tell the F.D.A. that the products operate just like older devices that had already been approved.
“So on the one hand, the manufacturer wheels in their new Ferrari to the F.D.A. and says, ‘Look, it’s a car just like the Model T,’ ” said Dr. Peter B. Bach, a pulmonary physician at Memorial Sloan-Kettering Cancer Center in New York and a former senior adviser to Medicare and Medicaid. “Then they go out in the marketplace and say to doctors, ‘Why would you drive anything but a Ferrari?’ This drives up the cost of care without any necessary actual improvement in outcomes.”
Created in 1976, the F.D.A.’s process for approving devices divides the products into three classes and three levels of scrutiny. Tongue depressors, reading glasses, forceps and similar products are called Class I devices and are largely exempt from agency reviews. Mercury thermometers are Class II devices, and most get quick reviews. Class III devices include pacemakers and replacement heart valves.
Congress initially allowed many of the Class III products to receive perfunctory reviews if they were determined to be nearly identical to devices already on the market in 1976 when the rules were changed. But the original legislation and a companion law enacted in 1990 instructed the agency to write rules that would set firm deadlines for when all Class III devices would have to undergo rigorous testing before being approved.
The agency laid out a plan in 1995 to write those rules but never followed through, the accountability office found. The result is that most Class III devices are still approved with minimal testing.
Agency officials told the accountability office investigators that writing the new rules was still important.
“When asked for their time frame for doing so, however, the officials did not provide one,” the report stated.
Dr. Susan Alpert, the chief regulatory officer of Medtronic, the leading maker of heart devices, said that many of the Class III devices that currently receive less scrutiny before approval would, once the agency completed its overhaul, be reclassified as less risky Class II devices.
“So the impression that F.D.A. is approving new technologies with little review is erroneous,” Dr. Alpert said.
Still, she said, “there is no question” that F.D.A. needs to fix its reclassification process.
Dr. Peter Lurie of the consumer group Public Citizen said that the accountability office’s report “shows the agency has turned a blind eye to many devices, some of them dangerous, by ignoring the statute and failing to reclassify them.”