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FDA must split focus on duties
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From The Buffalo (N.Y.) News, March 29

The Food and Drug Administration is 103 years old. That’s a long time for even the most agreeable siblings to remain together. It’s time now for both of them to move out on their own and take on the much more complicated duties each of them faces.

The FDA rose in response to public outrage about rats in the meat and about medicines that did nothing but clean out the patient’s wallet. Now, the public is still concerned with food that will make you sick and drugs that won’t make you well. But the task of protecting us has become a lot more complicated.

Foodstuffs and medicinal preparations come from many more places around the world and can be a lot more complicated, both in what they contain and what they purport to do. But the FDA is so understaffed and overstressed that food we shouldn’t eat still gets onto our shelves.

Witness all the poisoned peanut butter products that recently killed a few, sickened many and did significant harm to the business of the peanut butter makers who didn’t serve as a salmonella delivery system.

And, over on the drug side of the agency, the problem has two equally troublesome edges. An agency that has too much to do and too little staff to do it with has allowed onto the market drugs that should not be used, or at least should not be used in the ways their makers are marketing them. And the same agency has held up the development and release of medicines that could, properly prescribed and used, ease suffering and save lives.

It’s time to break the agency in two and, by assessing fees to the industries that benefit from a credible and efficient safety system, operate the new parts in a way that makes them more efficient and our lives safer.

As it is, the FDA’s drug portion is less a quality-control system for the multinational giants that develop, manufacture and distribute a dazzling array of medicines and medical devices than it is an impediment. The agency, in turn, is too dependent on those same corporations to devise, carry out and report the results of their experiments, prerelease clinical trials and post-marketing research. It’s a situation that benefits neither the pharmaceutical companies nor the public.

The food portion, meanwhile, cannot keep up with all the inspections it needs to do, and farming the job out to the various states has proven no improvement. The recent tainted peanut butter product outbreak grew under the noses of state inspection regimes in Georgia and Texas.

Establishing new agencies with firm lines of authority is necessary to keep up with the ever-more-complicated world of food and medicine, which has changed so much over the last century.
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