Two separate studies of the premarket approval (PMA) of heart medical devices finds they often receive Food and Drug Administration approval without requiring high quality clinical data seen in the FDA’s drug approval process.
The acting director of the FDA’s device division says that tightening up the approval process is ahead.
The FDA has taken heat from lawmakers and patient advocates for the standards it uses to approval medical devices, especially in light of the U.S. Supreme Court’s Riegel decision that shields device makers from patient lawsuits over defective products approved by the FDA.
One report in the December 30, 2009 Journal of the American Medical Association (JAMA) reviewed cardiovascular devices approved by the FDA between January 2000 and December 2007.
Author, Dr. Sanket Dhruva of the University of California, San Francisco says, “The findings in this study raise questions about the quality of data on which some cardiovascular device approvals are based. There is a balance between getting new drugs and devices to market quickly and ensuring the evidence of benefit is sufficient before FDA approval and marketing.”
He says the bar for medical devices should be higher because they are implanted and cannot be discontinued as drugs can.
The authors find that 65 percent of pre-market approvals were approved on a single clinical study. Only about half of the primary measures were compared to the outcomes from the control groups.
The authors found that FDA approval was “often based on studies that lack adequate strength and may be prone to bias.”
In a separate study, Dr. William Maisel at Beth Israel Deaconess Medical Center in Boston, working with FDA scientists, reviewed the approval of cardiovascular device PMAs between January 1, 2000 and December 31, 2007. They were looking at the quality of clinical investigation submitted by the manufacturers.
Their results are published online in the December 29, 2009 American Journal of Therapeutics.
In all the researchers evaluated 88 cardiovascular device PMAs the majority (77.3%) were for implantable devices. The researchers found gaps in high quality subject accounting finding omissions in reports about cardiovascular morbidity, artery disease, diabetes, tobacco use.
The American Journal of Therapeutics study found about 40 percent of heart and blood vessel studies failed to account for what happened to patients enrolled in the research and lacked precise targets for measuring safety. Dr. Maisel told the New York Times the potential for problems related to the devices and lower-quality data exists.
The Wall Street Journal talked to an official at AdvaMed, which is a device industry trade group. She says the FDA spends 1,200 hours looking at medical device applications and there is much data to be reviewed by an approval is granted.
The FDA may soon begin setting for defined targets to define success and require companies to conduct more follow-ups on patient outcomes, according to an article in the New York Times.
Medical Device Safety Act
Referring to the U.S. Supreme Court’s Riegel decision, which preempts lawsuits against defective device manufacturers, the JAMA article states, “The importance of FDA device approval is magnified as it preempts consumer lawsuits on device safety.”
The American Association for Justice, in news release “If device manufacturers are using flawed studies to gain FDA approval for potentially dangerous devices, then they need to be held accountable for the safety of their products,” said AAJ President Anthony Tarricone. “Passage of the Medical Device Safety Act is critical for patient safety, especially when medical devices have not gone through rigorous premarket testing and post-market monitoring.”
The Medical Device Safety Act (H.R. 1346/ S. 540) would remove the prohibition on the injured to file actions against the makers of defective heart defibrillators, artificial valves and hip and knee replacements. #