Sen. Harkin: Need to Examine FDA's Medical Device Approval Process

The following is the statement of Senator Tom Harkin (D-IA) at the HELP Committee hearing on "Medical Devices: Protecting Patients and Promoting Innovation."

“This is the third hearing we have convened as part of our ongoing process to reauthorize FDA user fee legislation. This hearing examines FDA’s regulation of medical devices.

“As the author of the American’s with Disabilities Act, I recognize that these devices often enable individuals to live their lives to the fullest.  It is hard to imagine modern medicine functioning without them, and countless patients have had their lives changed for the better by medical devices.  Accordingly, it is essential that we encourage the continual development and improvement of medical devices, and that efficient regulatory processes get innovative devices to patients as quickly as possible.  However, there is no virtue in getting devices to patients quickly if the devices don’t work or, worse, if they cause injury or death.

“Most Americans would be shocked if they understood the current process we use to approve most medical devices. People probably imagine that for every moderate or high-risk device – certainly anything implantable – experts at FDA examine clinical data and conclude that the device has been demonstrated to be safe and effective.  But that’s not what happens.  Most devices are “cleared” by FDA through a process in which a device must merely be shown to be “substantially equivalent” to another device already on the market, even if that predicate device, and its predicate device, and so on, were cleared the same way.

“This process gets devices to patients more quickly, but sometimes with catastrophic consequences for patients. Recently, for example, all-metal hip implants were cleared through the 510(k) process, in many cases without clinical data.  As it turns out, when the metal ball rubs against the metal socket, tiny metal particles can wear off and cause damage to the bone and tissue surrounding the implant, and the metal ions can get into the bloodstream and cause problems in the heart, nervous system, and thyroid gland.  Today, there are around a half million Americans walking around with a dangerous hip implant and no great options – do they have surgery to have the implant removed, or keep it and risk becoming another victim of the rush to get these products to market?

“There’s been a great deal of talk lately about promoting innovation.  I’m all for that, especially when innovation leads to the creation of jobs and even entirely new industries.  But promoting innovation doesn’t just mean willy-nilly getting products to the market so that device companies can make profits.  In a recent article, Dr. Gregory Curfman made the point that “true innovation” is not just a matter of getting products to market quickly, but also of ensuring that they are safe and effective.  A device is only a worthy innovation if it works, and if it doesn’t hurt people.  Speeding medical devices to market without adequate data and testing might be good for business in the short-term, and it might even create jobs at first.  But if the device is faulty, patients will pay the price, the business will be hurt, and the jobs will disappear.  As Dr. Curfman noted in his article: “Our regulators should not be in the business of creating jobs in the manufacture of dangerous devices.”  That is not a good business model at all.  I want to do everything possible to help US manufacturers to create innovative and safe devices, and get them to market as expeditiously as possible.  To that end, the FDA must strike the appropriate regulatory balance.

“At a minimum, FDA should reserve its streamlined 510(k) process for devices that are truly of moderate risk. Any high-risk device should be required to submit a premarket approval application.  Over 20 years ago, in the Safe Medical Devices Act of 1990, Congress made it clear that FDA should use its premarket approval process for high-risk class III devices, or it should reclassify them to a lower-risk category.  Despite this direction from Congress, high-risk devices continue to slip by this requirement.

“If we’re going to retain a system in which devices can be cleared based on substantial equivalence to predicate devices, we need to create assurance that the predicate device is safe, and works.  We need to follow cleared devices throughout their lifecycle so that we know how they perform in the real world.  That way, when a follow-on device seeks approval based on a predicate, we know something about how that predicate worked, and we will be more confident that “substantial equivalence” tells us something about safety and effectiveness.  Certainly, if a device turns out to be dangerous – if it is withdrawn or recalled for safety reasons – it is absurd to continue to allow that dangerous device to be used as a predicate for later products.  I intend to work with FDA and my colleagues on this Committee to strengthen and improve FDA’s postmarket authorities, so that we can all have more confidence in the 510(k) system’s ability to ensure patient safety."