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Talks on the European and U.S. trade agreement start this week and are being hailed by both sides as a way to strengthen their lagging economies. But for consumers, lowered trade barriers too often mean the crippling of vital public health and safety rules.
The danger — as we’ve seen in past trade agreements, including NAFTA — is that the effort to lower trade barriers will result in a regulatory race to the bottom where both sides’ health and safety laws roll back to the lowest common denominator. This “harmonization” approach to regulations would eliminate any safety rules on either side that could interfere with the free trade of products.
One extremely dangerous impact could be on the regulation of medical devices — everything from medical clamps and surgical tools to pacemakers. Millions of patients in America depend on an ever-widening array of these devices for diagnosing and managing their diseases and disorders.
The FDA is generally stricter than its EU counterpart, the European Medicines Agency, which relies on a decentralized approach to regulation that has allowed faulty and dangerous medical devices to reach European consumers.
For example, the EU recently approved — with only limited testing — a new type of stent graft to repair aortic aneurysms. When U.S. approval was sought for the same stent grafts, the FDA found that the devices presented risks to patients, including blood clots, graft failure, and ruptured aneurysms.
The FDA also found 11 other EU-approved high-risk devices that posed significant risks to patient health. These faulty medical devices were withdrawn from the EU market, but only after thousands of patients were harmed. None of these dangerous devices hurt people in America, thanks to our rigorous approval process.
Beyond their fragmented approval process, the EU also lacks the FDA’s extensive system for tracking problems when they occur. Here, if a medical device fails or causes harm, that information is reported back to the FDA and posted on a searchable database called MAUDE (Manufacturer and User Facility Device Experience). Across the pond, not only is the European version of our database closed off to the public, there’s also inconsistent data analysis to identify problems.
The FDA has developed invaluable systems for making sure that the drugs and medical devices in this country are safe to use. If we are forced to roll back these rules to match the EU’s versions, the results for the public health of Americans could be devastating.
As our decision makers embark on these trade negotiations, they must ensure that the result is not a regulatory race to the bottom. In the U.S., American patients can rely on the safety of the medical devices they need. In an attempt to restore the lagging economy, we should not carelessly throw out vital consumer protections that affect the quality of life of Americans.
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