Last week Senators on a key committee voted on a bill that will determine the safety of a medical device you or a member of your family may need someday—the committee’s bill includes some improvements that reflect actions of consumer activists have had an impact. In the past several months, Safe Patient Project activists have met with key Congressional members in DC and visited members in their home states; shared hundreds of stories about harm from flawed devices, some of which have been featured in news stories; sent thousands of emails and hundreds of calls to their elected officials; and testified before Congress.
Let’s get one thing straight: once device applications are sent to FDA, over 90% of them are OK’d for sale on a “fast track” that does not require the companies to show that the devices have been clinically tested for safety. As long as they show that this new device is similar to one already on the market, the FDA has to “clear” it for sale, even when the old device has been recalled for safety reasons. The FDA can’t even ask the device maker if its new device has corrected the flaws of the recalled device.
An amendment to the Senate bill offered by Senator Merkley from Oregon would have put an end to this practice of basing new devices on recalled ones. Unfortunately he did not have the support needed to adopt his amendment, but he will try again when the bill moves to the Senate floor.
The Senate committee bill is kind of a mixed bag – for example:
- It doesn’t address the problem of allowing new devices to be sold because they are like a recalled device, which we think is critical. However, when the FDA identifies a safety problem with a device, the bill helps the agency to more quickly “upclassify” that device to a higher risk status so that similar devices will no longer be “fast tracked” and will receive more scrutiny before they get to patients.
- Five years ago Congress authorized a unique device identifier system, similar to a car’s VIN number, but it’s never been put in place. The bill sets a timeline for putting this program in place so that FDA can track problematic devices and make sure patients are warned about safety problems. It’s about time!
- Currently the FDA can order a device maker to conduct follow up studies when patients and doctors identify safety issues – but the device maker can take as long as it wants to complete the study. In the meantime, these devices are being used and implanted in people. The bill sets a timeline for these studies to begin so that the FDA is able to react quicker to protect patients.
- Five years ago consumer advocates, including us, fought to limit the participation of experts with financial ties to the drug and device industry in FDA advisory panels. The Senate bill removes those limits, which we oppose. But the bill does require public reporting on conflicted panel members and requires FDA to beef up their effort to recruit non-conflicted experts.
We will continue to urge members of Congress to close the safety loopholes in the medical device bill as it continues to be debated and pushed to the final vote, expected in late July.
The medical device industry has taken notice of what consumers want improved, and we need your help to counter their well-funded lobby effort to sway Congressional votes in their favor and weaken safety oversight.
Between 2009 and 2011, medical device companies spent $86 million lobbying Congress and the Obama administration, according to data compiled by the Center for Responsive Politics and commissioned by the Union of Concerned Scientists. Over the same period, elected officials on a House subcommittee and a Senate committee with oversight over FDA received nearly $6.3 million in campaign contributions from drug and medical device companies.