The FDA's system for approving some moderate- to high-risk medical devices is beyond repair and needs to be replaced by a new system, according to a new report from the widely-respected Institute of Medicine (IOM). As the New York Times notes, the panel that produced the report "included physicians, academics and two lawyers who had worked for device makers on regulatory issues."
The group of medical devices in question are those that present a high level of risk to patients—what the FDA deems Class II or Class III devices. Class III devices are things like metal-on-metal hip joints, external defibrillators, dental implants and cranial electrotherapy stimulators. All of these devices seem like something that should require clinical trials before being marketed, but the FDA has a 35-year-old process called 510(k) that allows devices like these to skip all clinical trials and head right to consumers as long as the manufacturer shows they are similar to already-available devices, even if those devices are made by another company.
The FDA commissioned the report from the Institute of Medicine to look at the 510(k) process and figure out if it was working well and if not, how it could be improved. The FDA requires a “reasonable assurance of safety and effectiveness” before a device can be sold to consumers. However, the 510(k) process doesn’t evaluate anything about a device except whether it is substantially equivalent to previous devices. Thus it can’t really ensure the safety and effectiveness of these devices.
In 2009, POGO Executive Director Danielle Brian and POGO Staff Scientist Ned Feder sent a letter to the commissioner of the FDA pointing out the problems of the 510(k) process in connection with a syringe made by AM2PAT, Inc., that turned out to be infected with bacteria. The syringes were linked to deaths and serious illnesses in patients and eventually led to prison sentences for two AM2PAT employees.
The letter noted that the 510(k) process was actually shielding potentially harmful devices from oversight:
By making use of the 510(k) mechanism, new companies like AM2PAT are allowed to put potentially deadly devices on the market quickly and with little regulatory oversight by the FDA.
Congress introduced the 510(k) process in 1976 with the Federal Food, Drug, and Cosmetic Act and later amended the process. Of course there were already a large number of medical devices on the market before this approval process was created, but the FDA decided it couldn’t go back and re-evaluate every device. Now medical companies making new devices can argue their product is substantially equivalent to old devices—ones that were never approved by the FDA—and usually skip clinical trials or other thorough assessments.
The 510(k) process is still around because it’s fast and cheap. Medical device makers like it because it allows their products to get to the market quickly without a long approval process. The FDA likes it because their meager budget doesn’t allow the agency enough staff to carry out a comprehensive review of every Class II and Class III device. The 510(k) serves both the industry and the regulators, but occasionally it is a great disservice to consumers who end up with an internal defibrillator with defective leads attached to their heart or who end up receiving IV fluids from a bacteria-infected syringe.
AM2PAT submitted a two-page form arguing the similarity of its syringe to past syringes. The company asserted that “test data have been generated” without showing any of that data, and soon their syringe was off to market—and unsuspecting patients were off to the ICU or the grave.
The FDA does have an in-depth system in place for evaluating medical devices. It’s called premarket approval (PMA) and it is much more lengthy and costly for both the FDA and device companies than the 510(k) process. The base fee for device manufactures for a PMA application is $236,298, while the 510(k) process costs $4,348. And on the regulators’ end of things, it costs the FDA $870,000 to process a PMA application and $18,200 for a 510(k) application. The FDA lists 19 steps in the PMA process, including clinical trials, studies of the device’s engineering and shelf life, panel meetings and data reviews. PMA applications are supposed to be reviewed in 180 days compared to 90 days for 510(k).
The Government Accountability Office (GAO) examined the 510(k) process in a pair of 2009 reports. In January 2009, GAO concluded “In establishing device classes in 1976, Congress envisioned that all class III devices would eventually be required to undergo premarket review through the more stringent PMA process.”
But the GAO report showed that between 2003 and 2007, the FDA cleared 228 Class III devices through the 510(k) process. Again, Class III devices have a potential for high risk and include implantable products.
The Institutes of Medicine report, which came under fire from the medical device industry before it was even released, aims to push the FDA to make drastic reforms in the 510(k) process. This could bring FDA approval of Class III devices into line with the original intent behind the law. However, the FDA has a history of slow responses. As the GAO points out, the FDA had already committed to approving Class III products through the PMA process 14 years before the GAO called them out for their use of the 510(k) process in 2009.
The GAO report noted that the FDA was “committed” to reforming the 510(k) process but would not provide a time frame for when they would enact that reform.” Our question at POGO is: Will the FDA’s delay be measured in years or decades?
Andre Francisco is a POGO Associate.
Image: YIM Hafiz.