June 19, 2009

Legislation Sought To Increase FDA Oversight

In a review of the FDA's oversight of medical devices, a Government Accountability Office (GOA) discovered a high level of deficiency, which would expose the public to potentially harmful and defective medical devices. The report was submitted yesterday as testimony at a congressional hearing about possible legislation that would give the patient the ability once again to file lawsuits against the makers of medical devices.

In order to provide patients with better protection from safety risks, experts say the U.S. Food and Drug Administration's approval process for medical devices needs a major overhaul.

Pallone, the Democrat who chairs a House Energy and Commerce subcommittee said, "There is evidence of an approval system that is broken -- that its standards, its procedures and its rules don't meet modern needs of getting medical devices to those in need with confidence in their safety."

The GAO report reveals gaps in the FDA reviewing process, inadequate postmarket surveillance, and irregularly inspected medical device manufacturing facilities. Advocates of the new legislation refer to the report as substantial evidence that the FDA is incapable of guaranteeing safe medical devices, and that manufacturers must then be required to be wholly accountable for their product safety and effectiveness.

Healthcare director for the nonpartisan Government Accountability Office Marcia Crosse said that she found various deficiencies in regards to the FDA's pre-approval reviews and post-approval monitoring "that are necessary for ensuring the safety and effectiveness of medical devices."

Crosse told lawmakers that a closer examination of the FDA in recent years found that a rigorous review process was not required for all of the most potentially harmful devices and that the agency had a difficult time analyzing the tens of thousands of reports received every year claiming injury from devices.

Cardiologist William Maisel, who is in charge of the nonprofit Medical Devices Safety Institute, said that recent recalls of defibrillator wires and other devices raised doubts as to whether the FDA has the ability to quickly identify safety problems.

Over 20% of all automated external defibrillators (AED) have been recalled by FDA, and defective AED's have resulted in 370 deaths between 1996 to 2005.

Maisel told a House of Representatives Energy and Commerce subcommittee, "Additional consumer safeguards are needed. Only by demanding more thorough, scientific device evaluations can the FDA hope to reestablish consumer confidence in its ability to protect the public's health."

The device industry rose to the FDA's defense, insisting that it provided stringent oversight of thousands of medical devices every year.

"FDA has comprehensive authority to regulate medical devices through a combination of premarket and postmarket controls," said president of the Advanced Medical Technology Association, known as AdvaMed Stephen Ubl.

"It is important to remember that millions of Americans benefit from" devices each year, he said in a statement.

Republican lawmakers were critical of the fact that not one FDA official was asked to testify at the hearing.

FDA spokeswoman Mary Long said that the agency "takes its regulatory responsibilities over medical devices seriously" and was willing to answer all questions from lawmakers.

New FDA Commissioner Margaret Hamburg told Reuters earlier this week she would examine the use of a truncated approval process that criticized as being used for devices that necessitate a more comprehensive analysis.

Some lawmakers insist that issues could be better addressed with competent management, enforcement and more funding.

The FDA's own reviews have stated that both a lack of resources and increasing technical complexity of medical devices are to blame for their inability to maintain medical device safety standards.


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