Studies on the FDA Approval of PMA’s

Recent studies on the FDA approval of PMA’s indicate that FDA approved the devices without key info. The studies revealed that important patient information was lacking and safety targets not spelled out:
From an AP release on Dec. 29, 2009, the two study shortfalls in the FDA approval process included heart pacemakers and cardiac stents.

The FDA has been under scrutiny and criticism for the FDA's medical devices division. There were allegations that FDA scientists were pressured to approve certain products.

The year began with congressional investigators saying the FDA should take immediate steps to make sure the riskiest devices are approved through the most stringent process.

The FDA has already been in the process of redefining the medical research guidelines for devices. The new guidelines will be released in 2010 and the industry will be expected to adhere to these stiffer guidelines.

Additionally, the researchers from the Beth Israel Deaconess Medical Center and from the University of California, San Francisco studied the FDA approval process for heart and blood vessel medical devices. Both studies looked at devices approved from 2000-2007.

The researchers questioned the use of “foreign only” clinical studies using small groups of patients. Also, many of the clinical research lacked the standards most scientists expect: randomization and clearly defined study goal.

It is interesting to note that neither of the new studies didn't examine the safety of the approved devices, and didn't look for differences in the approval process for products that were later recalled.

The study’s conclusions stated that "Companies need to better define precisely what they're measuring and at what time point they intend to measure it," said study co-author Dr. William Maisel, director of the nonprofit Medical Device Safety Institute at Beth Israel Deaconess Medical Center. The analysis looked at the research behind 88 heart and blood vessel devices.

It is also interesting to know that Maisel was an FDA consultant and another Beth Israel author was in an FDA fellowship program when the study was done. The FDA cleared their participation after conflict-of-interest screening. Three other authors are FDA staffers. Does this represent any conflict?.

The second study appeared in Dec. 30th, 2009, Journal of the American Medical Association . Researchers from the University of California, San Francisco, examined summaries of the research behind 78 heart and blood vessel devices. They found that many devices were approved based on small studies — 300 patients on average — and two-thirds of devices were approved with results of just one study.

The study researchers stated, "We were surprised at the number of devices approved without high quality evidence.” The research was supported by the university's medical school.

There is much at stake with device approvals. In a US Supreme Court decision in 2008, it was found that federal law bars patients from suing manufacturers for injuries caused by FDA-approved devices. This does not hold true for the drug industry. Consumers can sue drugmakers over FDA-approved drugs. Drugmakers submit rigorous studies when seeking approval of new drugs, generally they must submit large randomized studies.

The studies under this evaluation only included the PMA reviews and not the 510(k) submissions. The FDA has asked the Institute of Medicine to evaluate its 510(k) reviews, following criticism from safety advocates and government watchdogs.

In looking at the studies the FDA did make the following comments, “the University of California researchers looked only at summaries of device approvals, rather than the full research.” The FDA also went on to state that the researchers also made faulty assumptions about device research, which is inherently different from drug research.

The most rigorous research randomly assigns patients to get either the experimental treatment or a standard treatment, or sometimes a placebo. Patients and sometimes doctors are "blinded," meaning they don't know which patients receive the experimental treatment.

FDA officials said requiring randomized studies for second and third generation devices would delay bringing engineering refinements to the market. They said it's often impossible to conduct blinded studies with devices.

It would appear that trying to apply the standard study approach used for drugs to devices is not appropriate in most cases and would not be practical.
It will be interesting to see what 2010 will bring to the device industry. But, with the present regulatory policies and with the Democratic controlled Congress, the change that may be coming may not be very comforting to the industry.

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