The FDA Approval Process for New Medical Devices Should be Stronger

If the public knew what goes on in the world of the multi-billion dollar medical device manufacturing industry with regard to seeking approval, they would be very concerned, to say the least.

Lobbyists are hired by the industry, working overtime, hoping the Food and Drug Administration will quickly approve their medical devices, putting millions of lives at risk.  The approval process of a medical device should be thorough and complex, not hurried and made weaker. The public has no idea what goes on in Congress or at the FDA.  That is why these companies hire lobbyists who control what happens in Washington.

The weak regulation of medical devices is causing serious health and safety problems for the public. Just recently we reported about the defective artificial hips manufactured by Johnson & Johnson/DePuy. Approximately 40,000 American patients, as well as tens of thousands of patients worldwide, required additional, painful, costly revision surgeries after the implants were recalled. The metal-on-metal hip implants were recalled after it was discovered that they carried the risk of releasing metal toxins into hip tissue, causing pain, inflammation and serious internal damage. If the medical device approval process were stronger, the public would be safer.  These lobbyists that represent the powerful medical device industry are trying to persuade lawmakers to quickly approve these devices before adequate testing is done. Once again, they are putting their profits before safety.

According to a review by an Institute of Medicine panel, it was recommended that the FDA dismantle the 510(k) program for expediently approving medical devices because it does not guarantee their safety or efficacy, as reported by the AP/Washington Post.  The panel said that some medical devices considered by the FDA to be “predicate devices” have been on the market since before certain medical device amendments, meaning new devices are being approved because of their similarity to older ones that never were found to be safe and effective. The panel also said that it found “substantial problems” in how devices are examined after their approval by FDA. They recommend that the FDA develop a new regulatory framework instead of dedicating its resources to fixing the current process.

Another serious issue is the approval process of prescription drugs. New prescription drugs are rushed to market, being approved by the FDA without adequate testing.  This is referred to as the Fast-Track by the FDA. Hundreds of drugs are rushed into production only to be recalled due to serious health and safety issues.  The public is not safe and we are badly in need of an FDA overhaul. The public should not settle for anything less.

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