It's another science-versus-commerce face-off.
Last Friday, the Institute of Medicine released a report commissioned by the FDA that proposes a vastly different and more rigorous approval process for medical devices. In the wake of several recent, well-publicized recalls of devices causing grievous injury, such as hip implants, the report has generated attention well beyond the medical-regulatory nerd community.
As the IOM, an arm of the National Academy of Sciences, explained, "Devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the 510(k) process.... Some policymakers and patients have expressed concern about the ability of the 510(k) process to ensure that medical devices on the market are safe and effective. Other policymakers and patients, as well as the medical-device industry, have asserted that the process has become too burdensome and time-consuming and that it is delaying important new medical devices from entering the market."
So the FDA asked the IOM to answer two questions:
- Does the current 510(k) process protect patients optimally and promote innovation in support of public health?
- If not, what legislative, regulatory, or administrative changes are recommended to achieve the goals of the 510(k) process optimally?
The answers? No, and (we're paraphrasing here) you need a makeover.
"The IOM finds that the current 510(k) process is flawed right from its legislative foundation. Rather than continuing to modify the 35-year-old 510(k) process ... the FDA’s finite resources would be better invested in developing an integrated premarket and postmarket regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the device life cycle."
Before the report was released, the medical device industry issued a pre-emptive strike. As reported in the New York Times, the industry called the report biased, and claimed that a greater regulatory burden would retard innovation, cost jobs and harm patients. "An official of a group that represents surgeons who implant hips and other artificial joints," the paper reported, "has also voiced support for a recent filing by a pro-business organization that challenged the scientific report’s credibility and argued that the F.D.A. was statutorily required to ignore it."
If it's not surprising that device manufacturers would object to greater scrutiny and bureacracy, it's highly unusual for any business interest to orchestrate a campaign against a thoroughly vetted recommendation before its report has been published. The IOM, The Times said, "was unaware of a previous instance in which one of its reports, sight unseen, was the target of a similar effort to invalidate it."
Ralph F. Hall, a professor of law at the University of Minnesota who also represents the medical device industry, denied that the pre-publication diss was intended to undermine its message, but only to question the IOM's methods of review. “I could have waited until the report came out,” Hall told The Times. “That seems intellectually less than satisfactory with me.”
So, someone whose professional obligation is to thoughtfully and thoroughly examine circumstances and then carefully apply the law to them is OK with assumptions about something unseen and indictments of a 12-person panel of doctors, lawyers, and academics who did perform the necessary due diligence?
The FDA commissioned the report, but it isn't required to take its advice. In fact, as noted by MedPage Today, Jeffrey Shuren, M.D., and director of the FDA's Center for Devices and Radiological Health, said the agency isn't keen to dump the fast-track approval process for moderate-risk devices. "FDA believes that the 510(k) process should not be eliminated but we are open to additional proposals and approaches for continued improvement of our device review programs," Shuren said.
Still, the agency will invite the public to comment on the report, and hold a public meeting in the next few weeks.
Patient and consumer advocates applaud the IOM report. Diana Zuckerman, president of the National Research Center for Women and Families, told MedPage Today that there are four major problems with the 510(k) process:
- it doesn't require device-makers to submit clinical trials;
- it doesn't mandate inspections of manufacturing facilities;
- it doesn't require post-marketing studies;
- it doesn't give the FDA any authority to rescind approval if the device is found to be unsafe or ineffective.
Most devices, from low-tech tongue depressors to something more complicated, such as pacemakers -- are fast-tracked with 510(k) approval. That requires companies seeking approval for a low-to-moderate risk device to prove that it's substantially similar to another device on the market. Completely new and high-risk devices, such as an implanted heart defibrillator, must provide clinical data demonstrating safety and effectiveness.
As noted in The Times' story, so-called metal-on-metal artificial hips (the subject of much scrutiny and many lawsuits), seemed to work well when tested on mechanical simulators. But they failed when implanted in patients.
No one questions the fact that governmental oversight agencies can be inefficient and slow. But when the use of a product or device presents life-or-death issues, can you be careful enough?
To make your feelings known about the IOM report and to find information about recalled products and devices, contact the FDA's Center for Devices and Radiological Health:
(800) 638-2041; firstname.lastname@example.org
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993