The public should be up in arms over the ongoing activities by the global, multi-billion medical device manufacturing industry in our Nation’s Capitol. The industry has its lobbyists working overtime to get the Food and Drug Administration to take shortcuts in the approval process of the medical devices that would put millions of lives at risk. The medical device approval process should be made stronger and certainly not made any weaker. The only reason that folks are not greatly concerned over the lobbying activities is that they don’t know what goes on either in Congress or at the FDA. That is why it’s so easy for lobbyists to control what happens in Washington.
Weak regulation of medical devices causes serious health and safety problems for the public. For example, consider the defective artificial hips manufactured by the DePuy division of multinational pharmaceutical company Johnson & Johnson. Two years ago, the company’s metal-on-metal hip implants were recalled because they carried the risk of releasing metal toxins into the hip tissue, which caused inflammation and serious internal damage. Just a few years after receiving the hips, which were implanted in 40,000 patients in the United States (and tens of thousands more worldwide), many patients required costly, painful and risky operations to replace the devices.
This is just one of many examples of medical devices that fell through the cracks of our nation’s system for regulating these devices, injuring or killing thousands of patients. Catastrophic failures, such as the all-metal hip implants, show that the FDA approval process should be strengthened and not weakened. Shockingly, lobbyists representing the powerful medical device industry are trying to persuade lawmakers to make the already-insufficient approval process even weaker than it is. Their aim is to push their products through a weakened process and get them to market as quickly as possible, even without undergoing adequate testing to assure that they are reasonably safe for patients. In other words, they are putting profits first and neglecting safety.
Unfortunately, the regulatory problems are not confined to medical devices. New prescription drugs are often rushed to market – many being put on what is referred to as the Fast-Track by the FDA – and approved by the agency without being adequately tested. There are hundreds of examples of drugs that were approved, rushed to market and later had to be recalled because of serious health and safety issues. We are badly in need of an overall of the FDA, and the public should insist that Congress properly fund the agency. Only when that is done, can the FDA do its job.
Source: Public Citizen
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