As we wrote a couple of months ago, the FDA has proposed that some gravely ill people get experimental drugs faster than the normal approval process allows. Now, the feds have issued guidelines for device makers to get their wares approved quickly, if they fill the unmet needs of people with life-threatening conditions.
The idea isn’t exactly new. Since the 1980s, the FDA has had a fast-track program for medical devices that it deems “substantially equivalent” to existing devices. The reasoning behind what’s known as the 510(k) process is to dispense with all or most of the clinical testing required by completely new products in order to get worthy new devices to market more quickly.
The guidelines provided earlier this month for the FDA’s Expedited Access Pathway Program (EAP) promise to fast-track medical devices to market without bypassing the pre-market approval (PMA) application process.
On the agency’s blog, FDA Voice, Dr. Jeffry Shuren, director of the FDA’s Center for Devices and Radiological Health, explained how the EAP, a voluntary program, is supposed to work. The FDA would work with a device’s developers during the approval process, and would require a Data Development Plan that shifts some data now collected during pre-market approval to post-market use. That means the manufactures wouldn’t have to provide some of their data about safety and effectiveness until the devices are already on the market.
If that sounds like a really bad idea, the feds justify the potential risk by saying they would limit the program to products “likely to predict clinical benefit,” according to Shuren. “Under the EAP, FDA may accept a greater degree of uncertainty if it is sufficiently balanced by other factors, including the probable benefits to having earlier access to the device.”
The program went into effect last week, and eligibility is limited to medical devices intended to treat or diagnose a life-threatening or irreversible and debilitating disease or condition. A device sponsor must submit an acceptable draft Data Development Plan and the device must meet at least one of these criteria:
- There is no other appropriate alternative treatment or means of diagnosis.
- It uses breakthrough technology that gives it a clinically meaningful advantage that existing technology lacks.
- It offers significant, clinically meaningful advantages not achievable by existing technology.
- Its availability is in the best interest of patients.
Skeptics question the value of the EAP because the FDA routine is criticized for its lousy track record of collecting high-quality, useful post-marketing data. AboutLawsuits referred to a study by the Pew Charitable Trust last year that showed how most FDA-approved medical devices classified as high-to-moderate risk lack publicly available scientific data proving their safety or effectiveness.
The feds have been accused of approving products before requiring their manufacturers to conduct post-marketing studies (post-approval studies, or PAS), so companies often begin selling devices after getting approval and blowing off the follow-up studies.
Most of the time, the Pew research suggested, the FDA doesn’t bother to ask for the post-approval studies and exercises little oversight of them. AboutLawsuits said, “The report found that from 2005 through 2011, the FDA ordered 223 studies for 158 medical devices. Only 48% of those devices deemed high risk were subject to such a study.”
Tellingly, when there is adequate PAS data, the FDA requires the company to change the product label more than half the time.
The “substantially equivalent” requirements of the 510(k) process have been expanded to include products that advertise using new technologies and techniques, and they can be radically different from their predecessors, say FDA critics. They say the term “substantially equivalent” has become meaningless. If the feds couldn’t keep the old fast-track process safe for patients, why are we supposed to believe this one is any better?
Lots of previously fast-tracked products have been recalled because they were found to be dangerous only after they were implanted in patients.
Many metal-on-metal hip replacements and transvaginal surgical mesh products, AboutLawsuits pointed out, found their way onto the market under the “substantial equivalent” test. There was little pre-market testing to ensure their safety.
Their manufacturers, of course, promoted them as “revolutionary” and vastly improved over older devices.
The 510(k) process originally was intended to speed noncritical devices to market; things like bandages and tongue suppressors, not the more invasive, more complicated devices that are implanted permanently into a human body.
The FDA knows it has a problem with fast-track approval. Last summer On July 28, it issued guidance about the definition of “substantially equivalent” to older devices. Shuren’s blog post said the agency is trying to address these concerns in various ways, and promised that the EAP’s priority review process and other aspects of the program should reduce the development cycle for critically necessary medical devices without a lowering of the FDA’s safety and efficacy standards.
We hope so.