The present target in the bomb-sights of Congress is the Federal Food & Drug Administration (FDA). They are preparing to cripple the agency by weakening the agency's power to oversee drug manufacturers, medical devices and food additives. How will this affect you, you ask? I'm glad you brought it up.
This measure will allow pharmaceutical companies to promote their products and medical devices for uses other than those that have been proven safe and effective. Perhaps you remember the hormone DES that was prescribed to prevent miscarriages, not its original tested purpose, and resulted in an epidemic of cancers in the female offsprings?
The House version would "privatize" many FDA functions. It will repeal reporting requirements the FDA and doctors use to flag problems that the manufacturers would just as soon not share. It will only mandate that drug companies notify the FDA when tests on human subjects begin and remove all FDA oversight completely thereafter.
But not to worry, my friends. The act provides for our safety through the creation of industry sponsored and controlled review boards. Of course, you can rest assured that the drug industry will provide open and honest critiques of themselves.
The bill provides that the industry submit only research summaries of their findings in tests rather the raw data so necessary to ferreting out negative effects. Without the raw data, the trends which indicate possible injuries or even deaths can be hidden and kept from the FDA and the public.
When it comes to the actual manufacturing of the drugs and devices, your best interests will be covered, as well, since the FDA will no longer be allowed to monitor the process. Instead, the separate companies will be allowed to hire private contractors for this need. Now that makes you feel warm all over, doesn't it?
Even in those instances where the FDA will continue to enjoy some small oversight the bill hobbles the agency by mandating that missed deadlines on approval could mean the product will be approved by default. Do you think that the industry might drag its feet in order that deadlines cannot be met by the agency and then their barely tested products approved by fiat? Nah! Not a chance, huh?
Finally, a "national uniformity" clause pre-empts state law and will make it difficult, if not impossible, for consumers to sue the manufacturer of defective or contaminated products. Now there is a section we can all be proud of.
So let's review. The FDA will transfer over to the industries nearly all of its power to control the testing, manufacturing and uses of drugs, medical devices and food additives. When the products begin killing or injuring vast numbers of Americans there will be no recourse for the consumer.
An interesting footnote to this is that President Clinton is apparently sending signals that he will sign this bill in order to appear more "business friendly". Just how far Clinton is willing to go to become more "Conservative" is yet to be seen, though.
The part that truly breaks my heart, though, is that there will be so many who read this and wonder why I'm even bringing the subject up. These folks honestly believe that this type of legislation must be acceptable solely because it is a Republican effort and that the business community must have our best interests at heart since that is what all the TV commercials claim.
I can only hope that the citizens of this country will eventually realize that neither the government that supposedly represents them nor the business community that lusts after their wallets will do anything progressive out of the goodness of their hearts. Only with the direct intervention of the power of the federal government do we stand any chance of continuing the history of safe and effective medical products. You can hate regulations but, as with airline and S&L deregulation, it's foolish to sacrifice safety for political purposes.
Well, the rest is up to you. I know you'll make me proud and write or call your representative about this foolishness. My job is to inform you, your job is to let your representative know your opinion. If you don't, the future is your fault.
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