The FDA Safety and Innovation Act passed the House Wednesday on a voice vote. Consumer advocates had mixed reactions since the bill left out some critical patient safety protections but could have been a lot worse given the political muscle of medical industry lobbyists.
For Consumers Union, the most disturbing issue that was left unaddressed by the bill is a dangerous loophole in the FDA’s 510(k) clearance process, which is used to review over 90 percent of all medical devices. By law, the FDA can only consider whether the new device is similar to one that has already been cleared and no evidence of clinical testing is required – even when the device it is based on is one that has been recalled by the manufacturer due to safety problems. Representative Ed Markey of MA introduced an amendment to prohibit recalled devices from being used to clear new ones but opposition from the medical device industry kept it out of the bill. We sent over 200,000 letters to Congress from their constituents and placed an ad in Politico to draw attention to the loophole.
On the plus side, the final bill included some stronger reforms that were included in the version of the bill passed by the Senate earlier this year. But overall, the final bill more closely reflects the agenda of the medical device industry than what’s needed to protect patients. Consumers Union’s Lisa McGiffert noted:
“This bill includes some important reforms that will improve the FDA’s ability to monitor medical devices on the market and to notify patients and require stricter testing when safety problems arise,” said Lisa McGiffert, director of Consumers Union’s Safe Patient Project. “But there is clearly more work that needs to be done to ensure that the FDA has all the tools it needs to ensure medical devices are safe and effective before they can be used on patients.”
With little enthusiasm for Rep. Markey’s amendment, we promoted a stripped down version amendment so the FDA would merely have the authority to require manufacturers of new devices to prove that the new device has fixed the flaws in a recalled predicate device that is used for clearance based on its similarity to the flawed device. But industry lobbyists managed to block that too.
Consumers Union found early in the negotiations the formidable pressure on Congress from the device industry and the need for consumer voices and advocacy organizations to promote patient safety. We sponsored a lobby day in Washington D.C. where people who have been harmed by faulty medical devices (surgical mesh, joint replacements and defibrillators) lobbied their Representatives and Senators.
As the final bill was being negotiated by House and Senate leaders, Consumers Union sent these lawmakers a story a day about people who have been harmed by a medical device in an effort to keep the medical device safety provisions in the bill.
Good provisions in the bill include:
- a deadline for creating a Unique Device Identifier (UDI) system for implants and high-risk devices. It’s extremely important that the FDA implement a system to identify each individual device implanted in a patient so if a device is recalled, the patient can be notified quickly.
- gives the FDA the authority to more easily reclassify problematic devices so that subsequent, similar devices must undergo more safety scrutiny before they can be used on patients.
- adds some provisions to improve post-market oversight, including adding medical devices to the “Sentinel Initiative” which pulls together different databases to help the FDA analyze patterns and more quickly identify safety problems with a device.
Ultimately the law gives the drug and device industries what they wanted: to speed up the approval of new products, getting them on the market quicker. To counter balance the problems with medical devices that were not identified before approval, there are some new tools that the FDA can utilize to monitor the safety of devices once they are on the market. Consumers Union would rather see life-saving and implantable devices thoroughly studied before they are allowed on the market to identify potential safety problems that can harm patients.
Throughout the course of our campaign, we’ve encountered many advocates who want to continue working with us to improve medical device safety. One of them is Dwight S. from Bellevue, Washington. Next week, Dwight is going to DC to attend an FDA advisory panel examining the safety of metal-on-metal hip implants and will share his wife’s story about her recalled metal-on-metal hip. The FDA received almost 16,800 adverse event reports about metal-on-metal hip implants from 2000-2011. Stay tuned for our blog post about the FDA meeting.