Whether on toothpaste or breakfast cereal, you can bet that when a "New and Improved!" label appears on a package, it means you'll pay more and get less.
Congress has learned this art of deceptive packaging, too. Hence, Newt Gingrich's 1995 proposal for a new tax giveaway to the privileged was labeled the "Job Creation Act." Likewise comes the "FDA Modernization Act of 1997" -- a twisted bit of legislation that "modernizes" the Food & Drug Administration's consumer-protection regulations like a tornado modernizes a trailer park.
This bill was not even written by a member of Congress. Instead, it's primarily the product of lobbyists for the giant manufacturers of drugs and medical devices. The industry put up $34 million in campaign contributions and, in turn, the Republican leadership of Congress allowed the lobbyists to "modernize" the laws regulating their own industry. No consumers were allowed to participate in this rewrite and no public hearings were held. The Health Research Group of Public Citizen, a consumer-watchdog organization, looked into it and found these uglies written into the new law:
Instead of the FDA reviewing safety claims of a medical device, now the manufacturer can select and hire its own private tester -- a brother-in-law deal if I ever saw one!
It used to be that at least two clinical investigations were necessary to OK a drug's effectiveness and safety; now, only one is required.
The rewrite also says that keeping track of the performance of heart valves and other high-risk medical devices is optional, rather than mandatory.
Finally, the new law tilts the regulatory process itself against us consumers and patients.
To learn more about this regulatory gut job, call Public Citizen's Health Research Group: (202) 588-1000.
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